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The FROZEN N, cryotherapy device using liquid nitrogen vapor, is for use when cold therapy 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).

The FROZEN N is a local cryotherapy device used for cooling down tissues by means of nitrogen vapors. Liquid nitrogen, whose boiling point is -196°C, inside the vessel changes into the gas form by heating from a rod-shaped immersion heater operated by AC power. The appearing difference in pressure between atmospheric pressure and the vessel provokes the flow of nitrogen vapors from the vessel to the hose finished with a nozzle mounted on handpiece. The nozzle discharge volume of nitrogen vapors is controlled in 5 levels by the operation time of heater. As the amount of nitrogen decreases, the device is off automatically when the temperature of the heater reaches 60°C where sensed via bimetallic thermometer embedded in heater module. The structural design of device is the movable cart equipped with a weighing system to check the amount of nitrogen in the vessel. Rapid cooling (thermal shock) in the temperature range of 2~4 ℃ occurs within 30-45 seconds when the spray sublimates as it contacts the skin. The device is controlled via touch screen keys of LCD where displays the timer, measured temperature, operating level and remains of nitrogen. Also, the touch key controls the aiming beams mounted on the nozzle side of handpiece that helps the user keeping a proper distance while the two laser beams meet each other. The LED on the hand-piece flickers when the measured drops below 5℃ and the device automatically shuts down when the measured temperature stays -1 ℃ or below for 1 second.

The provided text describes the 510(k) summary for the FROZEN N cryotherapy device, primarily focusing on its substantial equivalence to a predicate device (FROZEN C, K182392). The information does not detail a clinical study with specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) or human reader improvement with AI assistance, as it is a different type of medical device (cryotherapy) and the submission appears to be based on substantial equivalence rather than a new AI diagnostic algorithm.

However, the document does contain information about performance data and various tests. I will address the relevant sections of your request based on the available information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance tests conducted to demonstrate substantial equivalence, particularly concerning temperature.

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

The document mentions "skin temperature test on human subjects."

• Sample Size: Not explicitly stated beyond "human subjects."
• Data Provenance: Not specified, but generally, 510(k) submissions would involve testing conducted by the manufacturer or a contracted lab. The document does not specify country of origin or whether it was retrospective or prospective, though performance testing on a device implies prospective testing.

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

Not applicable in the context of this device and the type of performance testing described. Ground truth for a cryotherapy device's performance would be the direct temperature measurements, not expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. This device does not involve subjective assessment or image interpretation requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for AI image analysis or diagnostic support systems where human readers interpret medical images. The FROZEN N is a physical cryotherapy device. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the FROZEN N to its predicate device."

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

This question is not directly applicable to the FROZEN N device as it's a physical cryotherapy unit, not an AI algorithm. Its "standalone" performance is measured by its ability to deliver the intended temperature and operate safely and effectively. The performance tests ("skin temperature test," "temperature accuracy," "auto-off") confirm the device's functional performance.

7. The type of ground truth used

The ground truth for the performance claims (temperature, timing) was established through direct physical measurement. For instance, a "skin temperature test on human subjects" directly measured the skin temperature achieved by the device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" or development would involve engineering and design, followed by bench and human-subject performance testing.

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

Not applicable as there is no "training set" for an AI/ML algorithm in this context.

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