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TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge,

In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling. which controls the temperature (2-4℃) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -19C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

The principle of pain relief through skin cooling is as follows: As the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.

Here's a breakdown of the acceptance criteria and the study information for the TargetCool™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states, "TargetCool Temperature accuracy tests were conducted targeting three different treas (wrist, arm, back of neck) by three physicians at three different temperature settings (-10, -5, 5 degree C)." This implies the "test set" for temperature accuracy involved 3 anatomical areas and 3 temperature settings. The number of individual measurements or subjects is not explicitly stated beyond these categories.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a prospective bench test/performance test conducted by the company to confirm device specifications rather than a clinical trial with patient data.

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

• Number of Experts: Three physicians were involved in conducting the temperature accuracy tests.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, specialty) of these three physicians are not specified in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. The study described is a performance test, not one that requires adjudication of expert interpretations. The physicians conducted the tests and observed the device's output.

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

• No, an MRMC comparative effectiveness study was not done. The document describes bench testing and a comparison to a predicate device based on technical specifications and indications for use, not a study evaluating human readers' improvement with or without AI.

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

• Yes, a standalone performance test was done. The "Performance Data" section details bench testing where the device's temperature accuracy and compliance with various standards were evaluated directly. This is a standalone performance assessment of the device's physical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the temperature accuracy tests, the ground truth was based on the measured skin surface temperature using presumably calibrated instruments in a controlled testing environment, compared against the device's set temperature. For the other performance criteria (electrical safety, EMC, etc.), the ground truth was adherence to established international standards (e.g., ISO, IEC).

8. The Sample Size for the Training Set

• Not applicable/not mentioned. The TargetCool™ device is a cryosurgical unit, a physical medical device that applies cold therapy. It is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" or development of the device would involve engineering design and iterative testing, not data-driven machine learning.

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

• Not applicable/not mentioned. As explained in point 8, this is not an AI/ML device requiring a training set with established ground truth from data.

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