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MT ONE DIAMOND AND ITS HANDPIECE IS INDICATED FOR USE IN AESTHETIC, SURGICAL AND COSMETIC APPLICATIONS AND IN SELECTIVE TREATMENTS REQUIRED IN THE MEDICAL OF DERMATOLOGY AND GENERAL AND PLASTIC SURGERY.

MT ONE DIAMOND WITH HR808 NM LASER HANDPIECE IS INDICATED FOR HAIR REMOVAL AND PERMANENT HAIR REDUCTION.

PERMANENT HAIR REDUCTION IS DEFINED AS THE LONG TERM, STABLE REDUCTIONS IN THE NUMBER OF HAIRS WHEN MEASURED AT 6, 9 AND 12 MONTHS AFTER THE COMPLETION OF A TREATMENT REGIME.

Device Description

MT ONE DIAMOND is a laser emitting device that is operated with handpiece in contact with the skin.

MT ONE DIAMOND comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch.

A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpiece:

-HR808 nm Laser diode.

AI/ML Overview

Acceptance Criteria and Device Performance for MT One Diamond

The provided document describes the MT One Diamond, a laser-emitting device intended for aesthetic, surgical, cosmetic applications, and specifically permanent hair reduction.

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Indicated for aesthetic, surgical, and cosmetic applications, and selective treatments in medical dermatology and general/plastic surgery. Specifically, with the HR808 nm laser handpiece, it is indicated for hair removal and permanent hair reduction.	The device's intended use is stated to be the same as its predicate device. This implies the MT One Diamond meets the intended use criteria by demonstrating equivalence.
Permanent Hair Reduction Definition	Long-term, stable reductions in the number of hairs when measured at 6, 9, and 12 months after the completion of a treatment regime.	The device follows this definition for permanent hair reduction, as stated in its Indications for Use. While direct performance metrics for hair reduction are not explicitly provided in the summary, the claim of substantial equivalence to predicate devices for this indication implies meeting the performance standards for permanent hair reduction.
Safety	Compliance with IEC 60601-2-22 standards for safety.	The system complies with the IEC 60601-2-22 standards for safety.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standard for EMC.	The system complies with the IEC 60601-1-2 standard for EMC.
Software Verification & Validation	Software verification and validation testing conducted as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").	Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance.
Technological Characteristics	Same technological characteristics (energy source, laser/IPL source, control mechanisms) and specifications as its predicate devices.	MT One Diamond has the same technological characteristics and specifications as its predicate devices.

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

The provided 510(k) summary does not explicitly state the sample size used for clinical testing (e.g., for hair reduction efficacy) or the data provenance (e.g., country of origin, retrospective or prospective). The performance data section focuses on safety, EMC, and software, and concludes that the device is substantially equivalent to predicate devices based on shared intended use and technological characteristics. For hair reduction, the summary only defines "permanent hair reduction" but does not provide clinical data from trials.

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

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth, particularly for the efficacy aspects of hair reduction. Given the focus on substantial equivalence through technological comparison and standard compliance, detailed expert review for clinical ground truth is not explicitly mentioned in this summary.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) used for a test set. This type of detail is typically found in clinical study reports, which are not fully provided in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study appears to not have been done or is not reported in this 510(k) summary. The document does not describe any human-in-the-loop performance studies or an effect size of AI assistance, as the device is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device.

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

The device is a physical laser surgical instrument. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as it applies to AI/software for interpretation is not applicable here. Performance testing focused on the physical device's safety, EMC, and software's proper function, not on algorithmic interpretation.

7. The Type of Ground Truth Used:

For the performance data presented:

Safety and EMC: Ground truth is established by adherence to international standards (IEC 60601-2-22 and IEC 60601-1-2).
Software Verification and Validation: Ground truth is established by adherence to FDA guidance for medical device software.
For the hair reduction indication, the summary implies that the ground truth for establishing "permanent hair reduction" would be based on clinical follow-up measurements (6, 9, and 12 months after treatment regime completion) showing stable reductions in hair count. However, no specific study data proving this for the MT One Diamond itself is presented in this 510(k) summary, rather equivalence to predicates is claimed.

8. The Sample Size for the Training Set:

This information is not applicable as the MT One Diamond is a physical laser device, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

This information is not applicable as the MT One Diamond is a physical laser device, not a machine learning or AI algorithm that requires a training set.

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