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A-tone systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Intense pulsed light system is a unit for general surgery and in dermatology using intense Pulsed Light system intended to cut, destroy, or remove tissue by light energy emitted by flash lamp. It is a light source with a wavelength range of approximately 530nm~1100nm.

This equipment is composed of the main body and a hand piece which is an irradiation device, and, as an accessory part, protective goggles for protection of the worker.

• Operation principle: This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment and on and off of the equipment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.
  Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will radiate light, which will be outputted after being filtered to a certain wavelength (530nm~1100nm) by the two filters of the hand piece.

The provided text describes a 510(k) premarket notification for the A-Tone IPL System, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment for a new study. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed devices.

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

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new clinical study. The device's "acceptance" is based on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.
• Reported Device Performance: No performance metrics from a specific clinical study for the A-Tone IPL system are reported in the document. The filing states "Clinical Performance Data: Not Applicable" and "Non-Clinical Performance Data: Not Applicable" in the context of this submission. The "Performance Data" section primarily lists compliance with voluntary recognized standards (e.g., EN 1041, EN 980, ISO 9001, ISO 13485, ISO 14971, EN 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. The submission states "Clinical Performance Data: Not Applicable," indicating no specific test set or clinical study was conducted for this 510(k) submission to demonstrate performance in terms of efficacy or safety with new data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. As no specific clinical test set was used, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set data is presented.

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 an IPL system, not an AI-assisted diagnostic tool. There is no mention of MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is an IPL system, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No new clinical data or ground truth establishment relevant to a study is discussed. The "ground truth" for the device's substantial equivalence is based on its similarity to legally marketed predicate devices and compliance with established safety and performance standards.

8. The sample size for the training set:

• Not applicable. This submission does not describe a machine learning model or a training set.

9. How the ground truth for the training set was established:

• Not applicable. This submission does not describe a machine learning model or a training set.

Summary of available information regarding performance and acceptance:

The "Performance Data" section confirms that the A-Tone IPL System:

• Complies with recommendations from the FDA guidance document "Guidance on the Content and Organization of a Premarket Notification for a Medical Laser."
• Adheres to several voluntary recognized standards, including:
  • EN 1041 [1998-02] Information supplied by the manufacturer with medical devices.
  • EN 980 [2003] Graphical symbols for use in the labeling of medical devices.
  • ISO 9001 (2008-12-15) Quality management systems.
  • ISO 13485 [2003-7-15] Medical devices Quality management systems.
  • ISO 14971 [2007] Medical devices Application of risk management to medical devices.
  • EN 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility.
  • IEC 60601-1-2 [2007] Medical electrical equipment- Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility.
  • IEC 60601-1-4 [2000] Medical electrical equipment- Part 1: General requirements for Safety 4th Collateral standard: Programmable electrical medical systems.
  • IEC 60601-2-22 [1996] Medical electrical equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser equipment.
  • IEC 60825-1 [2007] Safety of laser products Part 1: Equipment classification and requirements.

The submission concluded that "performance testing, including software validation testing, electrical and mechanical safety testing according to EN 60601-1, electromagnetic compatibility testing according to IEC 6060 1-1-2... demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns." This suggests that compliance with these standards and successful completion of specified performance tests served as the "acceptance criteria" for demonstrating safety and effectiveness in the context of this 510(k) submission, leading to the determination of substantial equivalence.

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