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The SubNovii is intended for the removal and destruction of skin lesions and coaqulation of tissue.

The SubNovii Advanced Plasma Technology is a handheld battery powered device that, when activated and placed in close proximity to the skin, generates an ionized electrical arc through the tip of an electrode (Tip) to the skin without the device or the electrode touching the skin. The SubNovii Advanced Plasma Technology consists of the SubNovii handpiece, single use disposable tips and a battery charger.

The provided FDA 510(k) summary for the SubNovii Advanced Plasma Technology references acceptance criteria and studies primarily focused on establishing substantial equivalence to a predicate device, rather than defining novel performance criteria for a diagnostic AI device.

Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The primary "test" to demonstrate substantial equivalence was a thermal effects study on animal tissue, not human clinical data or a test set in the traditional sense for an AI device.

• Sample Size for Test Set: The study was conducted on 4 Yucatan mini Pig tissues (liver, kidney, muscle, and skin).
• Data Provenance: The study was performed on Yucatan mini Pig tissues; the country of origin is not specified, but it represents pre-clinical, in-vitro/ex-vivo data, not human patient data.

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

• The ground truth for the animal tissue study was established through histological evaluation with nitro blue tetrazolium (NBT).
• The document does not specify the number or qualifications of experts who performed this histological evaluation. It is implied that qualified personnel performed these evaluations as part of standard practice for such studies.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method as it would apply to a clinical test set with human observers. The evaluation was a direct histological assessment of tissue damage.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

• No MRMC comparative effectiveness study was done. This submission is for an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No standalone (algorithm-only) performance was done. This device is a physical electrosurgical tool, not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth for the thermal effects study was histological evaluation of animal tissue to determine the extent of tissue damage.

8. The Sample Size for the Training Set

• This submission is not for an AI device, so the concept of a "training set" for an algorithm is not applicable. The device's performance was evaluated through engineering tests and animal tissue studies.

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

• As this is not an AI device, there is no training set or associated ground truth establishment in the context of machine learning.

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