(23 days)
Central Station's intended use is to retrospectively receive; display and store monitored vital signs parameters and related data. Central Station displays the data and system alerts for review and evaluation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.
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. Central Station accepts data from Honeywell HomMed Patient Monitors (e.g. Sentry and Genesis) as well as the Honeywell HomMed MedPartner.
The provided text describes a 510(k) submission for the Honeywell HomMed Central Station version 4.0. It primarily focuses on the device's intended use and the general compliance of its software. However, it does not contain detailed acceptance criteria, specific device performance metrics, or a study that rigorously proves the device meets such criteria in a quantitative sense as typically expected for medical device performance evaluation (e.g., accuracy, sensitivity, specificity).
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Criteria: | Explicitly Stated Performance: |
| Software compliance with guidelines and standards referenced in FDA reviewer's guides | Demonstrated compliance with guidelines and standards. |
| Performance within specifications | Performed within its specifications. |
| Performance within functional requirements for software | Performed within its functional requirements for software. |
| Ability to retrospectively receive, display, and store monitored vital signs parameters and related data | Functions as intended: retrospectively receives, displays, and stores monitored vital signs parameters and related data. |
| Ability to display data and system alerts | Displays data and system alerts for review and evaluation by a healthcare professional. |
| Not intended for emergency use or real-time monitoring | Device explicitly states "not intended for emergency use or real-time monitoring." |
| Compatibility with Honeywell HomMed Patient Monitors (Sentry and Genesis) and MedPartner | Accepts data from Honeywell HomMed Patient Monitors (Sentry and Genesis) and MedPartner. |
Missing Information: The document does not provide quantitative acceptance criteria (e.g., specific accuracy thresholds, uptime requirements, response times, or error rates for display/storage) or specific performance metrics that would typically be a result of a direct performance study. The reported "performance" is a high-level statement of compliance with general expectations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The data refers to "monitored vital signs parameters and related data" but there is no information on the origin or nature of this data used for validation. The device's intended use is to "retrospectively receive; display and store" data, which implies it handles retrospective data, but this doesn't clarify the nature of data used for testing its own performance.
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)
- Number of Experts: Not applicable. The device is a "Patient Vital Signs Monitor Viewing Station" and its validation focused on software compliance, specifications, and functional requirements. It does not involve interpretation tasks where expert ground truth would be established for diagnostic accuracy, for example. The "review and evaluation by a healthcare professional" refers to the intended use of the displayed data, not the validation of the device itself by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The validation described is for software compliance and functionality, not for diagnostic or interpretive performance requiring adjudication of expert opinions.
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
- MRMC Study: No, an MRMC study was not done.
- Effect Size of Improvement: Not applicable. This device is not an AI-assisted diagnostic tool; it is a data display and storage system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The description of "software validation results demonstrated that the Central Station System was in compliance with the guidelines and standards ... and that it performed within its specifications and functional requirements for software" implies a standalone evaluation of the software's ability to process, display, and store data. However, it's not "algorithm only" in the sense of a predictive or diagnostic algorithm. It's a functional software system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated as "ground truth" in a clinical sense. For software validation, the "ground truth" would be the expected behavior or outcome based on the software's specifications and requirements. For example, if a vital sign reading is X, the "ground truth" for the display function is that it should display X correctly. The document only mentions that the software "performed within its specifications and functional requirements," implying that its output was compared against its design requirements for proper functioning.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. It is a software system for data display and storage.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.
In summary: The provided 510(k) summary focuses on the regulatory compliance and general functional validation of a software system designed to receive, display, and store vital sign data. It explicitly states that "the software validation results demonstrated that the 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 for software." This type of submission relies on demonstrating that the software meets its pre-defined design and functional requirements rather than clinical performance metrics often associated with diagnostic or AI-powered devices. The absence of quantitative performance data, expert reviews, or MRMC studies is consistent with the nature of this device as a data viewing station rather than a diagnostic tool.
§ 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).