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The Varaya Sport Mode 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.

The provided document is a 510(k) premarket notification for the Varaya Sport (Model 200), an infrared lamp. It details the device's characteristics, intended use, and a summary of safety and effectiveness testing. However, the document does not contain specific acceptance criteria, tabulated device performance data, detailed information about study designs (like sample sizes for test/training sets, data provenance), expert qualifications, ground truth establishment methods, or effect sizes of human reader improvements with AI assistance.

The document mainly focuses on establishing substantial equivalence to a predicate device (K112494, which is the same device) and confirming compliance with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, ISO 10993). It also mentions an "Over-the Counter Use Study" but provides only a high-level summary of its findings, not the detailed methodology or results needed to answer your questions.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from the provided text, nor can I provide the detailed study parameters you've asked for beyond what's explicitly stated.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance:

• This information is not provided in the document beyond a general statement of compliance with safety standards. No specific performance metrics or thresholds are listed.

2. Sample sizes used for the test set and the data provenance:

• For the "Over-the Counter Use Study," the document states, "Study participants were recruited solely from the general population, not specifically from a group of intended consumers. This was done to ensure an unbiased, naive sample representative of the general US population." However, no specific sample size is mentioned.
• The provenance (country of origin) is implied to be the US since the study aimed for a "representative of the general US population."
• The study appears to be a prospective user study focused on usability and label comprehension for over-the-counter use, rather than a clinical effectiveness study.

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

• Not applicable or not provided. The "Over-the Counter Use Study" was a user study about self-selection, usability, and label comprehension, not a diagnostic or AI performance study requiring expert ground truth in the traditional sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable or not provided. This was a user study, not an imaging diagnostic study requiring adjudication.

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. The document describes a traditional medical device (infrared lamp) and a user study, not an AI-based diagnostic device. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

• No. This is not an AI algorithm. The device is an infrared lamp.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "Over-the Counter Use Study," the "ground truth" was participant behavior and responses regarding self-selection, understanding of instructions for use, and potential risks of misuse. It was evaluated to confirm "a person was able to appropriately self-select themselves into using or rejecting the device" and that the "device design essentially mitigates anticipated risks of misuse and misunderstanding of the instruction for use." This is user behavior and comprehension, not medical diagnosis ground truth.

8. The sample size for the training set:

• Not applicable. This is not an AI device trained on data.

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

• Not applicable. This is not an AI device.

In summary, the provided document is a regulatory submission for an infrared lamp, focusing on demonstrating substantial equivalence and general safety/usability rather than the detailed performance metrics and study designs typically associated with AI/diagnostic device approvals.

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The Varava Sport Model 200 is indicated/intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and a control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adapter.

The provided 510(k) summary for the Varaya Sport Model 200 does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics through clinical trials. Instead, it relies on substantial equivalence to predicate devices and presents summary safety testing.

Here's a breakdown based on the information provided, highlighting the absence of the requested study details:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the submission. The submission states, "Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices." Therefore, no specific acceptance criteria for clinical performance (e.g., pain reduction scores, circulation improvement percentages) are outlined, nor is there any reported device performance data against such criteria.

The submission does mention:

• "The Varaya Sport Model 200 meets the required tissue heating requirements (tests provided)." - However, the specific requirements and results are not detailed in this summary.
• "Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided." - These are safety and electromagnetic compatibility standards, not clinical performance criteria.

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

Since no clinical performance study was conducted, there is no test set sample size or data provenance (country of origin, retrospective/prospective) for device performance against clinical acceptance criteria.

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

Given the absence of a clinical performance study, there were no experts used to establish ground truth for a test set regarding the device's clinical efficacy.

4. Adjudication Method for the Test Set

As no clinical performance test set was used, there was no adjudication method for such a set.

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

No MRMC comparative effectiveness study was conducted or reported. The submission explicitly states that formal clinical trials were not deemed necessary. Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone Study Was Done

No standalone study (i.e., algorithm only without human-in-the-loop performance) was conducted or reported, as this is a medical device for direct patient use, not an AI algorithm for diagnostic interpretation.

7. The Type of Ground Truth Used

For the purpose of substantial equivalence, the "ground truth" implicitly used is the established safety and efficacy profiles of the predicate devices. For safety testing (e.g., tissue heating, IEC standards), the ground truth would be adherence to specified engineering and safety standards. There is no clinical ground truth established through expert consensus, pathology, or outcomes data for this specific device's clinical performance.

8. The Sample Size for the Training Set

Since no clinical performance study was conducted, and the device is not an AI/ML algorithm that requires training data in the conventional sense, there is no training set sample size.

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

As there is no training set for an AI/ML algorithm, there is no method described for establishing its ground truth.

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