(50 days)
The HomMed Central Station intended use is to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within healthcare and home environments. Central Station, Version 3.3H includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature, and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, spirometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physicians and/or physician supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.
The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that accepts data from the HomMed Sentry Patient Monitors.
The provided text describes the HomMed Central Station, Version 3.3H, a device intended to retrospectively receive, display, and store physiological parameters. However, the document does not contain information regarding specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or how ground truth was established beyond a general statement of "software validation results."
The "Performance Data" section states that "The software validation results demonstrated that the HomMed Central Station 3.3H System 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." This is a high-level summary and does not provide the specific details requested in the prompt.
Therefore, I can only provide limited information based on the text.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. The performance is stated generally:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified) | Complied with guidelines and standards referenced in FDA reviewer's guides. |
| (Not specified) | Performed within its specifications and functional requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the provided document.
- Data provenance: Not specified in the provided document. The device itself retrospectively receives data, but the provenance of data used for validation is not mentioned.
3. 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)
- Not specified in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided document.
5. 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 is mentioned or implied. The device is a data display and storage system, not an AI-powered diagnostic tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies a standalone software validation was performed ("The HomMed Central Station is a software system... The software validation results demonstrated..."), but specific details on the methodology (e.g., comparison to a reference standard without human involvement) are not provided. The phrase "algorithm only" might not be fully applicable as it's a data management system, not a diagnostic algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not specified. The statement "performed within its specifications and functional requirements" suggests validation against predetermined software requirements and potentially functional testing, but the nature of the "ground truth" for the physiological parameters themselves is not detailed.
8. The sample size for the training set
- Not specified in the provided document.
9. How the ground truth for the training set was established
- Not specified in the provided document.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).