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The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.

The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of distinct "acceptance criteria" and "reported device performance" for each criterion. Instead, it describes performance characteristics related to safety and effectiveness, and how the subject device compares to predicate devices. The primary "acceptance criterion" demonstrated through testing is achieving a minimum skin temperature within a safe range.

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

• Test Set Sample Size: The document mentions that the measurement of the lowest skin temperature was "conducted with healthy volunteers." It does not specify the exact number of healthy volunteers used for this test.
• Data Provenance: The document does not explicitly state the country of origin where the skin temperature test was performed. The data is prospective, as it describes tests conducted for the submission. Other tests (electrical safety, EMC, software V&V, biocompatibility) are also described as prospective design verification and validation testing.

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

• Number of Experts: Not applicable/not stated. The skin temperature measurement was a direct physical measurement, not dependent on expert interpretation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the key performance test involved direct measurement (skin temperature), an adjudication method in the context of expert review is not relevant.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Although clinical studies were not needed to demonstrate substantial equivalence of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems..."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This device is a physical system combining cold and compression therapies, not an AI/algorithm-only device. The software controls pressure, displays battery level, and monitors/adjusts temperature, but its performance is integrated into the system's function, not evaluated as a standalone "algorithm only" product in the sense of AI.

7. The Type of Ground Truth Used

• For skin temperature measurement: The ground truth was established by direct physical measurement using sensors to record temperature on healthy volunteers.
• For other safety and performance aspects (Electrical Safety, EMC, Biocompatibility, Software): Ground truth was established through adherence to recognized international standards and regulatory guidance (e.g., IEC 60601, ISO 10993, FDA software guidance for medical devices).

8. The Sample Size for the Training Set

• Not applicable. This device does not involve AI/machine learning that requires a "training set" in the conventional sense for image analysis or diagnostic algorithms. The software's functionality is based on predefined control logic and algorithms for regulating temperature and pressure, not on learning from a large dataset.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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