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The Game Ready GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings or home settings.

The Game Ready GRPro 2.1 System and its accessories including Wraps is a medical device that helps athletes and patients recover from post-surgical and acute injuries to reduce edema, swelling, and pain. The Game Ready GRPro 2.1 System provides cold and compression therapy using ice and water in a portable device. The Game Ready GRPro 2.1 System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Unit through tubing to a Wrap that is designed for a specific body part (e.g., shoulder, elbow, knee, ankle, back) to treat pain and swelling from injuries and/or surgical interventions. The Game Ready GRPro 2.1 System is comprised of the following components:

• Control Unit ●
• AC Adapter (to convert line power to DC input power)
• . Connector Hose (connects Control Unit to the Wrap)
• Optional Carry bag ●
• Optional Battery Pack (Battery and AC charger) ●
• Wrap (Sleeve + Heat Exchanger) ●

The provided FDA 510(k) summary for the Game Ready GRPro 2.1 System does not contain any information about an AI/ML-based device or its acceptance criteria and study data.

This document is for a traditional medical device (a powered inflatable tube massager for cold and compression therapy) and focuses on demonstrating substantial equivalence to a predicate device. The performance data section refers to standard medical device testing like electrical safety, electromagnetic compatibility, software verification and validation, biocompatibility, and cleaning/disinfection.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these are not relevant to the device described in this 510(k) summary.

Specifically, to address your numbered points:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria in the context of an AI/ML model's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the device's adherence to safety and performance standards relevant to a physical medical device (e.g., temperature range, pressure levels, electrical safety, biocompatibility).
2. Sample sizes used for the test set and the data provenance: Not applicable. The document mentions "healthy volunteer human subjects" for a skin temperature measurement as required by guidance for heating and cooling devices, but this is a very limited human factors test, not a large-scale data set for model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood in AI/ML is not relevant to this device.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., actual temperature output, actual pressure, electrical safety compliance) verified through engineering tests, not expert consensus on medical images or patient outcomes data in an AI context.
8. The sample size for the training set: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a Class II medical device, the Game Ready GRPro 2.1 System, which provides cold and compression therapy. Its clearance is based on demonstrating substantial equivalence to a predicate device through engineering design verification and validation testing, not on the performance of an AI/ML algorithm.

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