(240 days)
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin.
Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy.
- Multifrax is a non-ablative and non-invasive fractional laser device.
- Multifrax is a light portable laser combining a small laser unit and 2 long lasting rechargeable batteries equipped with a belt clip.
- Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.
The provided text describes the "Multifrax Laser System" and demonstrates its substantial equivalence to a predicate device, the "Fraxel Dual 1550/1927 nm Laser System," through non-clinical performance testing. However, it does not include any studies involving human subjects or AI algorithms. Therefore, I cannot provide information on acceptance criteria and device performance based on a study, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
The document focuses on non-clinical testing to demonstrate safety and performance against established standards, not on clinical efficacy or comparative effectiveness with or without AI.
Here's a breakdown of what is available in the document regarding performance:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical performance standards and states that the "Multifrax Laser System was found to meet the requirements." It doesn't provide specific quantitative acceptance criteria or detailed numerical performance metrics for each standard within the text. Instead, it refers to compliance with the standards themselves.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical safety per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Met requirements |
| Electromagnetic compatibility per IEC 60601-1-2 Edition 4.0 2014-02 | Met requirements |
| Usability per IEC 60601-1-6 2010, AMD 1: 2013 | Met requirements |
| Laser equipment safety per IEC 60601-2-22 | Met requirements |
| Laser safety per IEC 60825-1:2014 | Met requirements |
| Software validation and verification per IEC 62304:2006 | Met requirements |
| Biocompatibility per ISO 10993-23:2021, ISO 10993-10:2021, and ISO 10993-5:2009 | Met requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as the testing described is non-clinical (i.e., not performed on human subjects).
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)
This information is not applicable as the document describes non-clinical testing against engineering and safety standards, not clinical ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical testing.
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
This information is not applicable as the document does not describe any clinical studies, MRMC studies, or AI components.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a laser system, not an algorithm, and the document describes non-clinical performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the document describes non-clinical testing against engineering and safety standards, not clinical ground truth.
8. The sample size for the training set
This information is not applicable as the device is a laser system, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a laser system, not an AI 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.