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TargetCool™ (Cooling mode / Boosting mode) 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™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures

• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Lesions
• Genital Lesions
• Seborrheic Keratosis

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, nozzle, a guard, a filter, and a cartridge.

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ 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 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.

The provided text describes the 510(k) premarket notification for the TargetCool™ device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth establishment relevant to AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The performance data section refers to bench testing (compliance with standards, biocompatibility, hazard analysis) and mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient," but it does not provide specifics about these clinical studies in the context of acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred and what is missing:

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

Missing Information (Not found in the provided text):

2. Sample size used for the test set and the data provenance: Not mentioned. The document refers to "Clinical publications and clinical data" but does not detail the nature, size, or origin of this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 cryosurgical unit, not an AI/ML diagnostic or assistive device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI algorithm in the typical sense of standalone performance. Its performance relates to its physical parameters (temperature, flow rate) and clinical outcomes, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For clinical effectiveness, it would likely be based on clinical outcomes data (e.g., successful tissue destruction for freezing mode, pain/swelling reduction for cooling mode). However, the document doesn't specify how ground truth was established for the "clinical data" it refers to.
8. The sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of the Study and Evidence Presented:

The core of the submission (K230599) is a substantial equivalence (SE) demonstration for the TargetCool™ device against two predicate devices (K221234 - an earlier version of TargetCool™ and K203481 - CryoVIVE). The study to prove acceptance criteria primarily seems to be a combination of:

• Bench Testing: Demonstrating compliance with recognized standards (ISO 13485, IEC 60601-1, IEC 60601-1-2, ISO 10993 for biocompatibility-by-proxy). These tests verify the device's physical and electrical safety and performance parameters like temperature accuracy within specified ranges.
• Safety Features Validation: Proving the alarm system for low skin temperature functions as designed.
• Clinical Data/Publications Review: The document states that "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient." However, it does not elaborate on the specifics of these studies (e.g., study design, sample size, primary endpoints, results). This clinical evidence likely serves to support the overall safety and effectiveness claims rather than precise numerical acceptance criteria.

The substantial equivalence argument is based on comparing the intended use, technological characteristics, and principles of operation to the predicate devices. Differences, such as the Boosting mode and modifications to the freezing nozzle, are addressed by arguing they "do not raise new questions of safety and effectiveness."

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