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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

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.

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CSI Model 9K Managed Health System Kiosk is an automated non invasive screening device intended for voluntary use by the general public. The device measures systolic and diastolic blood pressure, pulse and if optionally equipped, weight and temperature. Users may also manually enter or download blood glucose level. Data from the Model 9K may be stored by the user for tracking purposes. It is not a diagnostic device, and only furnishes data so users can consult their personal physicians.

The CSI Model 9K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in corporate lobbies and can be part of corporate wellness programs to track changes over time.

The device has a touch screen for user interface. The user may select from a menu of items. For instance, touching the button "Blood Pressure" on the touch screen will result in a sub menu that will direct the user to insert the arm in the cuff mechanism before pressing the "Start" button on the touch screen. The unit also consists of a "Release" push button that is separate from the touch screen. This "Release" button would result in the immediate deflation of the cuff and the aborting of the test. This well marked red button is meant for use in the event of an emergency. Other buttons on the main menu of the touch screen display would result in the user receiving the blood pressure (systolic and diastolic), heart rate, weight and temperature readings.

In addition to measuring the user's blood pressure, weight and temperature, the 9K may also be capable of accepting uploaded data from a One Touch Ultra Glucometer and playing videos on health topics. Data measured by the 9K or input into the 9K can be stored for tracking purposes. The 9K may also have the ability to display websites like WebMD, MayoClinic and corporate portals. Videos may present medical information and present symptoms but not diagnoses. The 9K may also be equipped with a scanner, printer, finger print reader and signature pad.

The provided text describes the CSI Model 9K Managed Health System, but it is a 510(k) summary for regulatory clearance, not a detailed study report. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics (especially for AI/algorithm performance) is not explicitly detailed in the document.

However, I can extract the information that is present and indicate where details are missing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to clinical evaluation and bench testing and "meets the requirements of AAMI/ANSI SP10:2002." This standard is for "Manual, automated, and the requirements for non-invasive sphygmomanometers," and specifies accuracy requirements for blood pressure measurements.

Specific quantitative acceptance criteria and the reported device performance against these criteria are not explicitly stated in a detailed table format within this document.

The document implies that the device achieved compliance with the following standards:

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the sample size used for the clinical evaluation (test set).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "clinical evaluation."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document, as it pertains to a clinical study design that is not detailed here. For blood pressure monitors, ground truth typically involves reference measurements taken by trained personnel using a validated method.

4. Adjudication method for the test set

This information is not provided in the 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

The CSI Model 9K Managed Health System is described as an "automated non-invasive screening device" that measures vital signs. It does not appear to be an AI-driven diagnostic device that assists human readers/clinicians in interpreting medical images or data. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device in the context of the information provided. The "AI" in this context refers to the automation of measurement, not interpretive assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" automated measurement kiosk. The document states, "The CSI Model 9K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate." And "It is not a diagnostic device, and only furnishes data so users can consult their personal physicians." This implies it operates independently to produce measurements. However, the performance evaluation would have been against a human-obtained reference.

7. The type of ground truth used

For blood pressure, the ground truth in clinical evaluations is typically established by simultaneous or near-simultaneous measurements using a recognized reference standard (e.g., auscultatory method with a mercury sphygmomanometer or another validated oscillometric device) performed by trained operators. This document does not explicitly state the method for ground truth, but it is implied by the adherence to AAMI/ANSI SP10:2002.

8. The sample size for the training set

The document refers to "the blood pressure, weight and pulse measurement systems used in Model 9K is exactly the same as the one used in the CSI Model 5K." This suggests a reliance on a previously cleared device. However, this is a hardware and core measurement technology statement, not a 'training set' in the context of machine learning. Since the device is not described as having an AI component that requires a training set, this information is not applicable in the AI/ML sense.

9. How the ground truth for the training set was established

As there is no mention of an AI/ML component requiring a training set in this summary, this information is not applicable.

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