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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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NanoTherm Indications:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

VascuTherm Indications:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
• Decrease the risk of deep venous thrombosis (DVT).
• Aids the blood flow back to the heart.
• Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various single patient use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists of a reusable pump (VascuTherm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.

The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the therapy site to reduce pain and swelling and compresses the extremity to enhance performance and fluid transfer and treatment of edema and lymphedema.

The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.

The NanoTherm and VascuTherm systems utilize microprocessor control with multiple sensors to ensure safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to prevent patient injury. Possible unsafe situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.

This is a 510(k) premarket notification for the NanoTherm and VascuTherm systems, seeking to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial would for novel efficacy claims. Instead, it focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices.

Therefore, many of the requested points regarding acceptance criteria and studies are not applicable or cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or stated based on the provided text:

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

The document doesn't provide a direct "acceptance criteria" table for the new devices in the sense of performance metrics to be met by a study. Instead, it presents a comparison of the new devices' characteristics (NanoTherm and VascuTherm) against predicate devices to demonstrate substantial equivalence. The acceptance criterion for a 510(k) is typically substantial equivalence, meaning the device is as safe and effective as a legally marketed predicate device.

The tables (Table 1, Table 3, and Table 5) provide comparisons of various parameters:

Indications for Use (NanoTherm):

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Indications for Use (VascuTherm):

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
• Decrease the risk of deep venous thrombosis (DVT).
• Aids the blood flow back to the heart.
• Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) summary, which typically involves demonstrating substantial equivalence through comparison of technological characteristics and safety/performance data with predicate devices. It does not describe a clinical study or a test set with a specified sample size, data provenance, or patient population in the context of demonstrating performance against acceptance criteria for a novel therapeutic claim. The patient population for intended use is stated as "non-ambulatory adult".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert assessment to establish ground truth.

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

Not applicable. The document does not describe a study involving 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

Not applicable. The devices are intermittent, external pneumatic compression devices, not AI-powered diagnostic tools, so MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device operating as intended, which is implied by the comparison to predicate devices and adherence to safety standards.

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

Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than a clinical study requiring ground truth for novel performance claims.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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