(39 days)
The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
Here's an analysis of the provided text regarding the Honeywell HomMed Genesis DM Monitor, focusing on acceptance criteria and study details.
Based on the provided document, there is no explicit mention of specific numerical acceptance criteria or a comparative study (like MRMC) for the device's performance in measuring vital signs. The document primarily focuses on regulatory compliance and the intended use of the device.
Here's what can be extracted and inferred:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Regulatory Compliance (General) | Compliance with applicable standards, guidelines, and regulations. | "Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards." |
| Software Validation | Compliance with FDA reviewer's guides and performance within specifications and functional requirements for software. | "The software validation results demonstrated that the Genesis DM Monitor was in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for software." |
| Intended Use Fulfillment | Ability to retrospectively monitor vital signs (noninvasive blood pressure, pulse rate, weight), transmit data, and extend capabilities with optional products. | The device is designed to fulfill these functions, and the regulatory approval implies it met the necessary requirements for this design and intended use. (No direct performance metrics are given, but compliance with standards suggests it meets expected operational capabilities.) |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size for any test set or the provenance of data used for performance testing. The 'performance data' section refers to general compliance testing (EMC, electrical, mechanical durability, safety, temperature/humidity) and software validation. These are typically engineering tests rather than clinical performance studies with patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. Given the nature of the tests described (EMC, electrical, mechanical, software validation), "experts" in the sense of medical professionals establishing a ground truth for diagnostic accuracy would not be applicable here. The ground truth for these engineering tests would be established by the specifications and standards themselves. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the types of engineering and software validation tests described. Adjudication methods are typically used in clinical studies where expert consensus is needed for ground truth. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done or reported. The device described is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. It's intended to collect and display vital signs retrospectively. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document mentions "software validation results demonstrated that the Genesis DM Monitor was in compliance... and that it performed within its specifications and functional requirements for software." This implies a standalone software validation was performed to ensure its functionality and adherence to specifications. However, this is distinct from a clinical performance study measuring diagnostic accuracy. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mentioned tests:- EMC, electrical, mechanical durability, safety, temperature/humidity testing: The "ground truth" would be the specific technical standards and regulatory requirements (e.g., IEC standards, UL standards, etc.) that the device was tested against.
- Software validation: The "ground truth" would be the pre-defined software specifications and functional requirements themselves, alongside relevant FDA guidelines for medical device software.
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The sample size for the training set:
Not applicable. The Honeywell HomMed Genesis DM Monitor is a vital signs monitoring device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of data-driven model development. The performance data refers to engineering and software validation tests. -
How the ground truth for the training set was established:
Not applicable for the same reasons as point 7. No training set for an AI model is mentioned or implied.
Summary of what the document does provide:
The document details the regulatory submission for the Honeywell HomMed Genesis DM Monitor. It states that the device primarily passed various engineering and software validation tests to demonstrate compliance with applicable standards and its own specifications. These tests ensure the device is safe, functions as intended, and meets regulatory requirements for its class. The device's intended use is retrospective monitoring of vital signs, not real-time or emergency monitoring, and it does not appear to involve AI or diagnostic interpretation that would require clinical performance studies with expert consensus or MRMC studies.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).