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Cold/Hot Compression combines cold, heat, contrast, and compression therapy. 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 post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

ColdHot Compression is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

The subject device is a prescriptive device, which combines cold/hot therapy and air compression. 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 post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

The subject device comes with the thermal-therapy wraps and the DVT wraps. The thermal-therapy wrap is nylon fabric on one side and velvet cloth on the other side; the DVT wrap is velvet on both sides. To avoid any potential adverse skin reactions such as redness, irritation, and cold/hot injury, the sock/clothing should be worn by the patient prior to use.

The subject device includes a main device and an optional DVT device, and has a limited shelf life of 3 years, based on the charge retention characteristics of the device's battery.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the typical sense.

Therefore, the information requested might not be fully available or explicitly stated in the provided text as it would be in a clinical study report.

Based on the provided text, here's what can be extracted and inferred:

1. Table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" here is primarily tied to demonstrating equivalence to the predicate device. The performance is assessed by comparing technical specifications.

Notes on Equivalence (as explained in the document):

• Note 1 (Cold Therapy): The subject device's cold therapy temperatures are within or similar to the range of the predicate/reference devices, and are adjustable by professionals. Differences are considered insignificant and do not raise new safety/effectiveness concerns.
• Note 2 (Heat Therapy): Similar to cold therapy, the heat therapy temperatures are within or similar to the predicate/reference devices and adjustable. Differences are insignificant.
• Note 3 (Edema Pressure): The subject device's lowest pressure is within the predicate's range and similar to the reference. The highest pressure is slightly higher but still adjustable by professionals. Differences are insignificant.
• Note 4 (DVT Pressure): The subject device's DVT pressures for calf and foot fall within or are slightly higher than the predicate/reference devices. Differences are insignificant.
• Note 5 (Cycle Length): The subject device's longest cycle length is similar to or longer than the predicate's, though shorter than the reference. Cycle length is adjustable. Differences are insignificant.
• Note 6 (Contrast Therapy Temp): The subject device's contrast therapy temperatures are either similar to the predicate or identical to the reference. No new safety/effectiveness issues.
• Note 7 (Contrast Cycle Length): The contrast therapy cycle length is slightly different from the predicate but identical to the reference. No new safety/effectiveness issues.
• Note 8 (Reservoir Fluid Capacity): The subject device's capacity is smaller than the predicate's but larger than the reference's. This difference does not raise new safety/effectiveness issues.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there is no test set in the sense of patient data from a clinical study. The "testing" involved non-clinical bench tests and comparison of specifications to predicate devices. The data provenance is from internal JKH Health Co., Ltd. testing and comparison to publicly available predicate and reference device information.

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment for a patient-based diagnostic or therapeutic outcome.

4. Adjudication method for the test set

Not applicable. There was no clinical test set 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

Not applicable. This device is a physical medical device (Cold/Hot Compression unit), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests would be the measured physical parameters of the device (e.g., actual temperature output, actual pressure levels, cycle times) against the device's design specifications and the specifications of the predicate devices. For safety standards, the ground truth is adherence to the requirements of the standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design was likely based on engineering principles and comparison to existing devices.

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

Not applicable. No training set was used.

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