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This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.

The provided text is a 510(k) Summary for a medical device (CWM-930S Radio Frequency Therapy System). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on studies involving AI or human reader performance.

Therefore, the document does not contain the information requested regarding acceptance criteria for AI device performance, sample size for test sets (in the context of AI models), data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI models, training set sample size, or how ground truth for training was established.

The "Performance Testing" section does mention some non-clinical performance tests for the CWM-930S device itself, but these are not related to AI model performance or human reader studies. Specifically, it mentions:

• Non-Clinical Test Summary [21 CFR 807.92(b)(1)]:

  • Electrical Safety, Electromagnetic Compatibility Testing: Compliance with IEC 60601 series standards.
  • Software Validation: CWM-930S has a MODERATE level of concern software that was designed, developed, verified, and validated according to FDA guidance.
  • Biocompatibility: Tested parts include the Cap, Electrode (needle and coating) made of SUS, and Neutral Electrode composed of Hydrogel, Cloth, Aluminum Film, Transparent Film, and Loctite Dura-Tak 129a. All showed biocompatibility for intact skin contact for limited duration (< 24 hours).
  • Sterilization, Shelf-life Testing: Ethylene Oxide Sterilization Test according to ISO 11135:2014/Amd 1:2018.
  • Performance Test: Validated output characteristics by load resistance, frequency, amplitude, duty cycle, and crest factor.
  • Thermal effect: Ex vivo animal testing using porcine abdominal skin to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post-treatment at low, mid, and high intensity. The study concluded that CWM-930 showed similar performance to predicate devices (VIVACE and SILKRO) regarding thermal effect.

• Clinical Test Summary [21 CFR 807.92(b)(2)]: States "No clinical studies were considered necessary and performed." This further confirms that no human reader or AI performance studies were conducted as part of this submission.

In summary, the provided document is a regulatory submission for an electrosurgical device, not an AI or imaging diagnostic device. Therefore, the information requested about AI performance acceptance criteria and study details is not present.

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