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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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The Med4 Elite™ combines cold, heat, contrast and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post traumatic and/or surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

The Med4 Elite™ (Model Number 650550) is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction and supervision of a licensed healthcare professional in rehabilitation facilities, outpatient clinics and athletic training settings. The device features iceless cold therapy, heat therapy, contrast (alternating heat and cold) therapy, and intermittent pneumatic compression therapy for one or two patients at a time. The device is designed to be compatible with the pre-existing portfolio of ergonomic Game Ready Wraps made for specific body parts (e.g., shoulder, elbow, knee, ankle, back, etc.). The Wraps are flexible water circulating garments that apply to the body to deliver cold, heat, or rapid contrast temperature and/or compression therapy. The wrap is comprised of an inner ATX Series Heat Exchanger and an Outer Sleeve. The Med4 Elite™ allows for treatment of one or two patients, or two anatomical locations simultaneously. The device is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. The physical description of the Med4 Elite™ is a compact unit with four caster wheels and a built-in handle. It has two separate, covered reservoirs - one for holding cold water and the other for holding hot water. The water reservoirs, pumps, cold engine, valves, power supplies and any other electronics are inside a covered enclosure made out of both plastic and sheet metal that can only be accessed with a tool.

The provided document is a 510(k) premarket notification for a medical device called "Med4 Elite™" by Cool Systems, Inc. (dba Game Ready). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed study results for a new device's performance against specific metrics, particularly in the context of an AI/ML diagnostic device.

Therefore, the information required to fully answer the request, especially regarding acceptance criteria for an AI device (like sensitivity, specificity, AUC), sample size, ground truth establishment for AI training/test sets, expert adjudication, or MRMC studies, is not present in this document. This device is a physical therapy device (a powered inflatable tube massager combining cold, heat, contrast, and compression therapies) and not an AI-powered diagnostic tool.

However, I can extract the information relevant to the performance testing and safety assessment of this specific device as presented in the document.

Here's what can be extracted from the provided text regarding the device's validation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the typical sense of quantitative performance metrics (like accuracy, sensitivity) that would be common for diagnostic AI devices. Instead, it describes various performance tests and their outcomes, primarily to demonstrate safety and functional equivalency to predicate devices. The "performance" is more about adherence to safety standards and functional operation within specified ranges.

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

• Test Set Sample Size: The document mentions "healthy volunteers" for the clinical study measuring skin temperatures (Table 3), but it does not specify the number of volunteers (sample size).
• Data Provenance: The study was a "clinical study" on "healthy volunteers" which implies it was prospectively collected. The country of origin is not explicitly stated, but as it's an FDA submission for a US company, it's highly likely to be US-based data.

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

This question is not applicable to the Med4 Elite™ device. The device is a therapy device, not a diagnostic device requiring expert interpretation of images or other data to establish "ground truth" in the AI sense. The "ground truth" for the skin temperature study was direct measurement of skin temperature. No experts are mentioned in this context for establishing "ground truth."

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. There was no expert "adjudication" in the sense of reconciling divergent interpretations for a diagnostic test set. The validation involved direct physical measurements and compliance with engineering/safety standards.

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 device is not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance was not performed and is irrelevant to this device type.

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

Not applicable. This is not an algorithm/software-only device. Its "performance" is based on its physical operation and thermal/compression outputs. The software component is described as a "Moderate Level of Concern" for control, not for independent diagnostic performance.

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

The "ground truth" for the clinical study was direct physical measurement of skin temperature on healthy volunteers using sensors, as well as adherence to established engineering and biocompatibility standards.

8. The sample size for the Training Set:

Not applicable. This device did not involve an AI model requiring a "training set" in the machine learning sense. The device's "training" would be its design and manufacturing process, and its "validation" is through engineering tests and a small clinical safety study.

9. How the ground truth for the Training Set was established:

Not applicable, as there was no AI model training set.

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