(57 days)
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:
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Removal of unwanted hair, for stable long term, or permanent, hair reduction* through selective targeting of melanin in hair follicles;
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Removal or lightening of unwanted hair (with or without adjuvant preparation);
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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
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1, IEC 60601-2-22, IEC 60601-2-57 (safety) and IEC 60601-1-2 (EMC). |
| Software Verification and Validation | Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". |
| Technological Characteristics | "MT ONE has the same technological characteristics (energy source, laser/IPL source, control mechanisms) and specifications as its predicate devices." |
| Intended Use | "MT ONE device's Intended Use is the same Intended Use of its predicate device." |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.