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Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

Radio Frequency Hand piece The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain.

Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.

Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.

The provided text is a 510(k) Summary for the A-FIT device, which combines a laser and radiofrequency (RF) handpiece. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for specific clinical indications.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted in the way typically found in a clinical trial report. However, I can summarize the information provided about the device's performance data and its regulatory compliance.

Here's a breakdown of what can be gathered from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical performance metrics for the device's clinical efficacy (e.g., success rate for acne treatment). Instead, it states that the device was tested against recognized performance standards for safety and essential performance. The "reported device performance" is essentially its compliance with these standards, indicating it meets safety and basic functional requirements.

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

The document does not describe a clinical test set in terms of patient numbers or demographic data. The "test set" in this context refers to the device itself being subjected to various engineering and safety tests according to the listed consensus standards. Therefore, specific sample sizes for a clinical test set and data provenance (country of origin, retrospective/prospective) are not applicable or provided.

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

This information is not provided. The "ground truth" for the non-clinical tests described is the established requirements of the referenced industry standards (e.g., IEC, ISO). There is no mention of external human experts establishing a clinical ground truth for device performance in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to a clinical study methodology. The tests conducted were against technical standards, not adjudicated clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned or described. This document is a 510(k) summary, which generally relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety, rather than providing comparative effectiveness data or human reader improvement with AI assistance. The A-FIT is a physical medical device, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance:

The document describes the performance of the A-FIT device in a standalone manner, meaning the device itself (laser and RF handpiece) was tested against various safety and performance standards. It does not refer to an "algorithm only (without human-in-the-loop performance)" because the A-FIT is a therapeutic device operated by a human, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for the reported performance data is the consensus international and national standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971, 21 CFR 1040.11) outlining safety, essential performance, EMC, usability, risk management, software validation, and biocompatibility for such medical devices. There is no mention of expert consensus derived from clinical cases, pathology, or outcomes data in this summary.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The A-FIT is not an AI/machine learning model whose performance is dependent on a 'training set'. Its design and functionality are based on established engineering principles and its manufacturing processes adhere to quality systems.

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

This question is not applicable, as there is no training set in the context of this device.

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