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The Stayhealthy SH650 is intended to be used by the general public so that the user can measure his/her own blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and if the user may have color blindness. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. The user can also choose to print the data or send the data to a personal physician or a healthcare professional.

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The provided text from the FDA 510(k) clearance letter for the Stayhealthy Kiosk SH650 and SH650-C does not contain the specific details about the acceptance criteria and the study used to prove the device meets those criteria.

The letter acknowledges the substantial equivalence (SE) determination, which means the device is considered as safe and effective as a legally marketed predicate device. This determination is based on information provided in the 510(k) submission, which typically includes performance testing data. However, the clearance letter itself is a summary of the FDA's decision, not the detailed technical documentation of the device's performance study.

To answer your request, I would need access to the actual 510(k) submission (Tradition 510(k) or Special 510(k) - K123539) which would contain the study reports and acceptance criteria.

Based only on the provided text, I can infer the general type of device and its intended use, but not the specifics of its performance study.

Here's what I can extract/infer from the provided text, and what is missing:

Device Name: Stayhealthy Kiosk SH650 and SH650-C
Regulatory Number: 21 CFR 870.1130 (Noninvasive Blood Pressure Measurement System)
Primary Function (based on Indications for Use): Measures blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and color blindness.

Information NOT available in the provided text:

1. Table of acceptance criteria and reported device performance: This would typically be a table showing specific metrics (e.g., accuracy, precision) for each measurement the device performs (blood pressure, body composition, etc.) and the target values (acceptance criteria) vs. the actual measured values.
2. Sample size used for the test set and the data provenance: The number of subjects or samples used in the performance study, and whether the data was collected prospectively, retrospectively, or from a specific region/country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For blood pressure, this might involve human observers using a reference device. For body composition, it might involve DEXA scans or other gold standard methods read by qualified professionals.
4. Adjudication method: If a consensus was needed for ground truth, how disagreements were resolved.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study focuses on how AI assists human readers. Given the nature of a self-service kiosk measuring vital signs and body composition, an MRMC study is unlikely to be relevant, as it's not an AI-assisted diagnostic imaging interpretation device.
6. Standalone (algorithm only) performance: While the kiosk operates in a standalone manner for data collection, the term "standalone performance" often refers to an AI algorithm's performance without human intervention in a diagnostic context. Here, the device itself is the standalone measurement system. The performance would be assessed against a gold standard.
7. Type of ground truth used: For blood pressure, the ground truth is often established by simultaneous measurements with a validated reference device (e.g., mercury sphygmomanometer with trained observers). For body composition, it might be DEXA (Dual-energy X-ray Absorptiometry).
8. Sample size for the training set: Not applicable for a device like this unless it uses a machine learning model for certain measurements, and even then, this specific detail would be in the submission, not the clearance letter.
9. How the ground truth for the training set was established: Same as above.

Conclusion:

The provided FDA clearance letter is a regulatory document confirming substantial equivalence and does not detail the technical performance studies and acceptance criteria that were part of the 510(k) submission. To answer your specific questions, access to the full 510(k) submission for K123539 would be necessary.

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