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

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.

The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.

Specifically, the document lists:

• Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
• Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
• Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
• Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.

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