Software as a Medical Device (SaMD)

From GM-RKB
(Redirected from SaMD)
Jump to navigation Jump to search

A Software as a Medical Device (SaMD) is a medical device that is medical software (it has been designed and developed to carry out medical functions without the need for computer hardware).



References

  • https://infomeddnews.com/5-software-as-a-medical-device-examples/
    • QUOTE: ... Here are five examples of SaMD to further explain how these devices assist medical professions in collecting the data they need to make better medical decisions to help patients recover from various types of health issues.
      • Patient Data SaMD: Several SaMD fall under this heading and include such things as the software used to collect patient data in real-time measurements that can be displayed and monitored remotely by a medical professional. The data may include heart rate stats, blood pressure readings, and other similar pieces of vital statistics.
      • Image Data SaMD: By analyzing and manipulating images and data collected from radiation-emitting imaging devices, this software can create 3D models. ...
      • Treatment Data SaMD: Patient information is analyzed with this type of new technology software that is used as an algorithm. ...
      • Sleep Data SaMD: Rather than using a sleep lab setting, this software analyzes the physiological signals collected when a patient is sleeping. ...
      • Breast Screening SaMD: This software uses the identical digital mammogram that radiologists use and calculates breast density percentage with it. ...

2019

2017

Clinical Evaluation
Valid Clinical Association Analytical Validation Clinical Validation
Is there a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition? Does your SaMD correctly process input data to generate accurate, reliable, and precise output data? Does use of your SaMD’s accurate, reliable, and precise output data achieve your intended purpose in your target population in the context of clinical care?
Figure 1 - Clinical Evaluation Process

2015

2015 SoftwareasaMedicalDeviceSaMDApp Fig1.png
Figure 1: SaMD Quality Management Principles: Leadership and Organization Support, Processes, and Activities.
  1. As identified by IMDRF SaMD WG N12 document

2014

State of Healthcare situation or condition Significance of information provided by SaMD to healthcare decision
Treat or diagnose Drive clinical management Inform clinical management
Critical IV III II
Serious III II I
Non-serious II I I
Criteria for Category IV –
i. SaMD that provides information to treat or diagnose a disease ]or conditions in a critical situation or condition is a Category IV and is considered to be of very high impact.
Criteria for Category III –
i. SaMD that provides information to treat or diagnose a disease or conditions in a serious situation or condition is a Category III and is considered to be of high impact.
ii. SaMD that provides information to drive clinical management of a disease or conditions in a critical situation or condition is a Category III and is considered to be of high impact.
Criteria for Category II –
i. SaMD that provides information to treat or diagnose a disease or conditions in a nonserious situation or condition is a Category II and is considered to be of medium impact.
ii. SaMD that provides information to drive clinical management of a disease or conditions in a serious situation or condition is a Category II and is considered to be of medium impact.
iii. SaMD that provides information to inform clinical management for a disease or conditions in a critical situation or condition is a Category II and is considered to be of medium impact.
Criteria for Category I –
i. SaMD that provides information to drive clinical management of a disease or conditions in a non-serious situation or condition is a Category I and is considered to be of low impact.
ii. SaMD that provides information to inform clinical management for a disease or conditions in a serious situation or condition is a Category I and is considered to be of low impact.
iii. SaMD that provides information to inform clinical management for a disease or conditions in a non-serious situation or condition is a Category I and is considered to be of low impact.

2013

Mobile apps that meet the definition above are considered SaMD.