(195 days)
The SoloHealth Station is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision. SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.
The SoloHealth Station is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in indoor high-traffic commercial areas. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series for interactive screen and voice instructions. Additionally, the SoloHealth Station measures weight, screens clarity of central vision, and does a risk factor analysis. Users are advised to consult a physician. Upon completion, data may be stored by the user and accessed via a website or sent via electronic mail to the user.
The SoloHealth Station is an automated system intended for the general public to measure blood pressure and pulse rate, weight, and screen for clarity of central vision.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Component/Aspect | Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Blood Pressure | AAMI/ANSI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003 (Manual, electronic or automated sphygmomanometers) | Bench testing for AAMI SP10 was completed separately by the supplier of the blood pressure module. Verification testing performed by the supplier ensures compliance with AAMI SP10 for the blood pressure cuff. Both of these components are not altered when assembled in the SoloHealth Station. Clinical testing according to AAMI SP10 was completed by the supplier of the blood pressure module on the module itself. The module is not altered when assembled in the SoloHealth Station. Full AAMI SP10 testing protocol was executed in Duluth, GA on the final device design and has shown that the SoloHealth Station kiosk demonstrates compliance to AAMI SP10. Additionally, confirmatory testing was completed with the SoloHealth Station on a limited number of subjects to ensure that the use of an alternate cuff does not affect the results as compared to the AAMI SP10 testing on the module. |
| Electrical Safety | IEC 60601-1:1988+A1:1991+ A2:1995 (Medical Electrical Equipment Part 1-2: General Requirements for Safety) | |
| IEC 60601-2-30:1999 (Particular Requirements for Safety, including essential performance, of automatic cycling non-invasive blood pressure measuring equipment) | Electrical safety testing was completed in accordance with the specified standards. Several clauses indicated failures initially, but these were re-tested, resulting in satisfactory results, or justification was provided that the clauses were not applicable to the SoloHealth Station (located in an indoor environment). | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2001 (Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard: Electromagnetic Compatibility) | Electromagnetic compatibility testing was completed and passed in accordance with IEC 60601-1-2:2001. |
| Software Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) | |
| "Non-invasive Blood Pressure (NIBP) Monitor Guidance" (March 10, 1997) for a device of moderate concern. | Software validation has been satisfactorily completed according to the specified guidance documents. Device Risk Hazards Analysis, Software Requirements Specification Architecture Design Chart, Software Design Specifications, Traceability Analysis, Software Development Environment Description, and Revision History were completed. | |
| Vision Screening | Similarity to a licensed Optometrist | Vision Screening Validation of the SoloHealth Station demonstrates that the screenings of the SoloHealth Station are similar to a licensed Optometrist. |
2. Sample size used for the test set and the data provenance
-
Blood Pressure:
- The blood pressure module (component within the SoloHealth Station) underwent clinical testing according to AAMI SP10 by its supplier. The number of subjects for this initial testing is not specified in this document.
- Subsequently, "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects" in Duluth, GA. The exact number of subjects for this confirmatory study is not provided.
- Data Provenance: The confirmatory testing was done in Duluth, GA, presumably in the USA. It appears to be prospective data collection for the confirmatory study. The provenance of the supplier's clinical data is not specified.
-
Vision Screening: The document states that "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects." The exact sample size is not provided.
- Data Provenance: Testing was done in Duluth, GA, presumably in the USA. This appears to be prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Blood Pressure: For the AAMI SP10 clinical testing, the standard requires specific expertise for ground truth measurements. While not explicitly stated in this document, AAMI SP10 typically necessitates trained observers for auscultatory reference measurements.
- Vision Screening: The ground truth for vision screening was established by comparison to the "screenings of a licensed Optometrist." The number of optometrists is not specified.
4. Adjudication method for the test set
- The document does not specify a formal adjudication method (e.g., 2+1, 3+1) for either the blood pressure or vision screening test sets.
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 involving human readers with and without AI assistance is mentioned in the provided text. The device is a standalone kiosk for self-measurement and screening.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance testing for the SoloHealth Station (which includes the blood pressure and vision screening functions) appears to be focused on its standalone performance in comparison to established standards and human expert assessment. The device is an "automated system" for self-measurement by the general public.
7. The type of ground truth used
- Blood Pressure: The ground truth for blood pressure measurements is based on compliance with the AAMI SP10 standard, which involves comparison to reference methods (typically auscultatory measurements by trained observers).
- Vision Screening: The ground truth for vision screening is "similarity to a licensed Optometrist." This implies a comparison of the device's screening results to those obtained by a human optometrist.
8. The sample size for the training set
- The document does not provide information on a specific training set or its sample size. The focus is on the performance testing against established standards and human expert equivalents.
9. How the ground truth for the training set was established
- Given that no specific training set is outlined, information on how its ground truth was established is not provided. The development process would likely have involved data for algorithm development, but this document focuses on regulatory performance testing.
§ 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).