(94 days)
The HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.
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 is an accessory to the HomMed Sentry Patient Monitors.
Here's a breakdown of the acceptance criteria and study information for the HomMed Central Station, based on the provided text:
Summary of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Functional Requirements | Intended use as defined: retrospectively receive, display, evaluate, analyze, and store certain monitored physiological parameters (NIBP, pulse rate, SpO2, temperature, weight). Not for emergency use or real-time monitoring. | "Software validation results demonstrated that the HomMed Central Station System... performed within its specifications and functional requirements." |
| Performance Specifications | Operation on commercially available PC systems with minimum performance specifications consistent with typical PC hardware. | "Software validation results demonstrated that the HomMed Central Station System... performed within its specifications and functional requirements." (Implies it met the PC requirements and overall performance). |
| Regulatory Compliance | Compliance with relevant guidelines and standards referenced in FDA reviewer's guides. Specifically mentioned: |
- Medical Software Validation Standards
- EN 60601-1 Medical Electrical Safety
- EMC Compliance IEC 601-1-2
- ISO 10993-5, 10-11 Biocompatibility (Though Biocompatibility might be for associated hardware, not directly the software, it's listed under compliance). | "Software validation results demonstrated that the HomMed Central Station System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides..." |
| Safety | General safety requirements for medical electrical systems. | "Software validation results demonstrated that the HomMed Central Station System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides..." (Likely covers safety implicitly). |
Study Information
Based on the provided text, the submission is a 510(k) Premarket Notification for the HomMed Central Station. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical efficacy trials typically seen for PMA applications.
Here's what can be inferred about the "study" mentioned for this device:
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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 states: "The software validation results demonstrated that the HomMed Central Station 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 indicates a software validation study was performed. However, no specific sample size for a "test set" of patient data is provided. The validation would likely involve testing various scenarios and inputs to ensure the software (Central Station) accurately receives, displays, evaluates, analyzes, and stores the physiological parameters from the HomMed Sentry Patient Monitors.
- Data provenance is not specified. Given the nature of a software validation, it would likely involve simulated or representative data, potentially from a variety of sources but not explicitly stated. The intent is to process data acquired "within healthcare and home environments."
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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):
- The document does not mention the use of experts to establish ground truth for a test set in the context of validating algorithmic performance. The validation appears to be centered on the software's functional correctness and adherence to technical specifications. The "healthcare professional is responsible for the interpretation of the monitored data."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The study described is a software validation, not a clinical study involving adjudication of interpretations.
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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, an MRMC comparative effectiveness study was not done. The HomMed Central Station is described as "a retrospective data view and analysis system" and an "accessory device used by the healthcare professional to display and evaluate the monitored patient data." It does not claim to incorporate AI or provide interpretations that would necessitate an MRMC study comparing human performance with and without AI assistance. The healthcare professional is explicitly stated to be "responsible for the interpretation of the monitored data."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the "software validation" serves as a standalone performance assessment of the algorithm/software's functionality. The validation assesses if the software, in isolation, correctly receives, processes, stores, and displays data according to its specifications. However, it's crucial to note that this "standalone" performance is within the context of a retrospective display and analysis system, where final interpretation remains with the human professional. The device is not making diagnostic decisions on its own.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a software validation of this nature, the "ground truth" would likely be derived from:
- Expected system behavior: Comparison of the software's output against predefined functional and performance requirements.
- Input data accuracy: Ensuring that known input physiological data is accurately processed and displayed by the system.
- Compliance with standards: Verifying that the software adheres to established software development and medical device standards.
- There is no mention of pathology, expert consensus on patient conditions, or outcomes data being used as ground truth for this software validation.
- For a software validation of this nature, the "ground truth" would likely be derived from:
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The sample size for the training set:
- Not applicable/Not mentioned. This device is not described as an "AI" or machine learning device that requires a training set in the typical sense. It is a data management and display software system.
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How the ground truth for the training set was established:
- Not applicable, as there is no indication of a "training set" for AI/ML processes.
§ 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).