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MT ONE and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.

MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.

MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of benign Pigmented and Vascular Lesions in skin types (I-V) to the Fitzpatrick scale.

MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) with Sub-Millisecond Technology (S.M.T.) is indicated for the treatment of erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).

MT ONE with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated Hair removal and permanent Hair reduction in all skin types (I-VI) to the Fitzpatrick scale

MT ONE with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

MT ONE with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:

· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

• · Removal or lightening of unwanted hair (with and without adjuvant preparation)
• · Treatment of pseudofolliculitis barbae (PFB)
• · Benign vascular 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.

MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:

• · Benign vascular and pigmented lesions, age spots
• Nevus spilus
• Tattoo removal

MT ONE with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for

· Post-operative Scars, Acne Scars, Skin Resurfacing, Striae

MT ONE is an Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin.

MT ONE comprises a main console unit and several handpieces that are triggered by means of footswitch or a finger switch.

The main console of MT ONE is the same, with no modification, of the predicated devices cleared by K172413. The difference is only in the addition of 4 new handpieces, see list below.

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 handpieces:

Handpieces that are already cleared by K172413

• -HR808 nm laser diode
• -AC415-950 nm Intense Pulsed Light
• -VPLP535-950 nm Intense Pulsed Light
• -SR580-950 nm Intense Pulsed Light
• -HR580-950 nm Intense Pulsed Light
• -HR635-950 nm Intense Pulsed Light
• -2940 nm ERBIUM YAG laser
• -1064 nm ND:YAGLP laser

Handpieces object of this submission:

• 532/1064 nm ND:YAG Q-Switched laser -
• -Fractional non-ablative 1540 nm Er:Glass laser
• -VPLP535-950 nm Intense Pulsed Light with S.M.T.
• -HR635-950 nm Intense Pulsed Light In Moving

The provided text is a 510(k) summary for the MT ONE device. It details various aspects of the device, its intended uses, and comparisons to predicate devices. However, it does not contain specific acceptance criteria, performance metrics, or study designs that would typically be found in a clinical study report. The "Performance data" section only mentions biocompatibility testing, electrical safety/EMC, and software verification/validation, which are engineering and regulatory compliance tests, not clinical performance studies.

Therefore, many of the requested details about acceptance criteria and clinical study performance cannot be extracted from this document. The document focuses on establishing substantial equivalence based on technological characteristics and safety standards rather than clinical efficacy studies with ground truth.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or specific levels of treatment success) or report device performance against such criteria. The performance data section focuses on engineering and regulatory compliance (biocompatibility, electrical safety, software V&V) rather than clinical outcomes.

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

• Cannot be provided: The document does not describe any clinical test set or study participants. The testing mentioned is related to engineering and software, not clinical trials.

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)

• Cannot be provided: No clinical test set or ground truth establishment process is described.

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

• Cannot be provided: No clinical test set or adjudication method is described.

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

• Cannot be provided: This document describes a laser and IPL device for various skin treatments, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI assistance is not applicable and not mentioned.

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

• Cannot be provided: As mentioned above, this is not an AI algorithm but a physical medical device.

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

• Cannot be provided: No clinical ground truth is described in the context of the performance data provided. The document outlines comparisons of technical specifications and intended uses to predicate devices to establish substantial equivalence.

8. The sample size for the training set

• Cannot be provided: The document does not describe any machine learning or AI components that would require a training set.

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

• Cannot be provided: Not applicable, as there is no mention of a training set for an AI/ML model.

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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.

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.

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:

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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MT ONE and its Hand Pieces are intended 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 with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with AC415-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick Scale.

MT ONE with VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with HR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with SR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with HR635-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick Scale.

MT ONE with Er-Yag2940USnm Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids;

Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

MT ONE with Nd:YAG1064(LP)USnm Laser Handpiece is indicated for:

• Removal of unwanted hair, for stable long term, or permanent, hair reduction* through selective targeting of melanin in hair follicles;

• Removal or lightening of unwanted hair (with or without adjuvant preparation);

• Treatment of pseudofolliculitis barbae (PEB).

*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.

MT ONE is an Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin.

MT ONE comprises a main console unit and several handpieces that are 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 handpieces:

• HR808USnm Laser diode;
• AC415-950USnm intense Pulsed Light;
• VLPL535-950USnm Intense Pulsed Light;
• HR580-950USnm Intense Pulsed Light;
• SR580-950USnm Intense Pulsed Light;
• HR635-950USnm Intense Pulsed Light;
• Er-Yag Laser 2940 nm;
• Nd:Yag LP Laser 1064 nm.

This FDA 510(k) summary for the MT ONE device, a laser and IPL system for aesthetic and surgical applications, does not provide the level of detail typically found in a study demonstrating acceptance criteria for AI/ML-driven devices. This document describes a traditional medical device and its equivalence to predicate devices, rather than an AI/ML algorithm.

Therefore, many of the requested fields cannot be filled as they pertain to algorithm performance evaluation, which is not present in this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

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

Study Details (as per request, with limitations due to device type):

The document describes the device as being "substantially equivalent" to predicate devices, rather than a clinical study establishing new performance metrics. The "performance data" section focuses on regulatory compliance and comparison to predicates, not specific clinical outcome metrics.

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 for this document. This document focuses on the device (a laser/IPL system) and its regulatory compliance and equivalence to predicate devices, not on the performance of a specific algorithm on a test set of 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. There is no mention of a test set requiring expert-established ground truth for an algorithm.

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

• Not applicable. No test set or expert adjudication process is described for an algorithm.

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 document is for a physical medical device (laser/IPL system), not an AI-driven diagnostic or assistive tool for human readers.

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

• Not applicable. This is not an algorithm-only device.

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

• Not applicable. The "ground truth" conceptually in this submission is the established safety and effectiveness of the predicate devices and the physical testing of the MT ONE device against relevant international standards (e.g., IEC 60601 series).

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned.

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

• Not applicable. No training set for an algorithm is mentioned.

Summary of what is present:

The document serves as a 510(k) summary for a medical device (MT ONE) that is a laser and Intense Pulsed Light (IPL) emitting system. The acceptance criteria and "proof" of meeting those criteria are framed in terms of:

• Compliance with recognized electrical safety and EMC standards (IEC 60601 series).
• Software verification and validation according to FDA guidance.
• Substantial equivalence to previously cleared predicate devices in terms of intended use and technological characteristics (energy source, laser/IPL source, control mechanisms, specifications).

The document's purpose is to demonstrate that the MT ONE device is as safe and effective as existing legally marketed predicate devices, not to establish novel performance metrics for a new AI/ML algorithm.

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