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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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The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.

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The provided text is a 510(k) premarket notification letter for the Stayhealthy Body Composition Monitor-BCM. It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance reports, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the specific details requested in your prompt (points 1-9). The letter is primarily an FDA clearance notification, not a technical report detailing the device's validation.

Therefore, I cannot provide the requested information from this document.

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The Stayhealthy BC1 and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology.

The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time.

The BC1 and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT1 and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.

The Stayhealthy BC1 and Stayhealthy/ Fitness expert BC2, Body Composition Analyzer is a computer-operated and web enabled body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and lean body mass percent. Both devices are about 10 inches across. The BC1 has an oval shape and is about 3 inches thick. The BC2 has an almost square shape with rounded corners. Both devices are made of slate grey plastics with polished metal inserts that are held by the hands to emit and receive signals to and from the body. The BC1 has an RS232 output socket and the BC2 has a USB output socket. Both devices have a dock where the calorie tracker is docked to upload its data. The CT1 and CT2 are both about 2 by 3 inches and made of slate gray plastics with a single display window and a docking port. They can be attached to clothes on the body via a clip on the back.

Here's an analysis based on the provided text, outlining the acceptance criteria and study details for the Stayhealthy BC1/BC2 Body Composition Analyzers:

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner. Instead, it describes a clinical trial proving the device's accuracy and then concludes that the device is "safe, effective and perform as good as or better than the predicate device." Therefore, the reported device performance is aligned with the outcome of this study, aiming for a tight correlation and no significant difference from the "gold standard."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 72 subjects
• Data Provenance: The study was commissioned by Stayhealthy and performed by the University of East Tennessee. This suggests the data is likely from the United States.
• Retrospective or Prospective: Not explicitly stated, but clinical trials are typically prospective studies where data is collected for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in the traditional sense of expert review for medical imaging or diagnosis.
• Qualifications of Experts: The "gold standard" for body fat estimation used was hydrostatic immersion. This is a scientific measurement method, not typically performed by "experts" in the sense of physicians or radiologists making diagnoses. The specialists performing and interpreting hydrostatic immersion would be trained in this specific anthropometric technique. The document does not specify their roles or qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison was made between the device's measurements and the "gold standard" (hydrostatic immersion), which provides a direct quantitative measurement. There was no need for adjudication among multiple human reviewers for interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Was it done?: No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device against a "gold standard" measurement, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Was it done?: Yes, the described study is a standalone performance study of the Stayhealthy BC1 device. It compares the device's output (body fat percent via BIA) directly to a "gold standard" measurement (hydrostatic immersion), without human interpretation as part of the primary outcome assessment.

7. The Type of Ground Truth Used

• Ground Truth Type: A "gold standard" scientific measurement: Hydrostatic Immersion for estimation of body fat percent.

8. The Sample Size for the Training Set

• Sample Size: The document does not provide information about a specific training set size. The study described is a clinical validation study, likely for the already developed algorithm. The development and training of the BIA algorithm would have occurred prior to this validation study, and those details are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

• How Established: The document does not provide information on how the ground truth for any potential training set was established. Given the nature of BIA devices, the training of the algorithm typically involves comparing BIA readings against known body composition measurements (like DEXA, hydrostatic weighing, or other validated methods) in a diverse population to establish the predictive model. However, these details are absent from the provided text.

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