(52 days)
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin type I-VI), including tanned skin. 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.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
The provided text describes the acceptance criteria and study proving the device's substantial equivalence to predicate devices, focusing on technical and safety aspects rather than clinical performance data with specific acceptance criteria related to a clinical outcome.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of clinical acceptance criteria. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical specifications and adherence to safety and performance standards. The "performance" reported is primarily the device's compliance with these standards and its technical similarity to the predicates.
| Acceptance Criteria (Implied from Comparisons & Standards) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (General) | Complies with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014. |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5:2009 (Tests for in vitro cytotoxicity). |
| Biocompatibility (Irritation & Skin Sensitization) | Complies with ISO 10993-10:2010 (Tests for irritation and skin sensitization). |
| Laser Product Safety (General) | Complies with IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification and requirements). |
| Laser Product Safety (Surgical/Cosmetic) | Complies with IEC 60601-2-22:2019 (Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment). |
| Software Validation | Complies with FDA Final Guidance-General Principles of Software Validation and IEC62304-2015. Level of Concern classified as Moderate LOC; validation confirmed no unacceptable risk. |
| Risk Management | Complies with ISO10993-1 Fifth edition 2018-08 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management). |
| System Operation | Met specified requirements (bench testing). |
| Wavelength | Met specified requirements and is similar to predicate devices (810nm nominal, similar to 808nm and 810nm nominal of predicates). Slight difference (808nm vs 810nm) deemed not to affect safety or clinical effectiveness based on absorption curves. |
| Single Pulse Laser Energy | Met specified requirements. |
| Repetition Frequency | Met specified requirements and is similar to predicate devices (1-10 Hz vs. 5-10 Hz/0.5-3 Hz and 1-10 Hz). |
| Laser Power Output | Met specified requirements. |
| Cooling Parameters | Met specified requirements. Employs Sapphire Contact and TEC Cooling, comparable to predicate and deemed to improve safety. |
| Fluence | 1-40 J/cm², lower than predicates (2-120 J/cm² and 10-125 J/cm²), implying "safety is better." |
| Pulse Duration | 3-160 ms, smaller than predicates (3.3-200 ms and 10-400 ms), implying "safety is better." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing and compliance with various standards, not a clinical study with a "test set" of patient data or a specific sample size of subjects. The verification tests were performed on the device itself.
Therefore, there is no mention of a "sample size" for a test set in the clinical sense, nor data provenance like country of origin or retrospective/prospective status as it pertains to 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 provided as the device's clearance is based on technical performance and safety standards, not on a clinical performance study requiring expert ground truth in diagnostics or treatment outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided because the submission focuses on technical specifications, safety, and substantial equivalence to predicate devices, not a clinical trial with a test set requiring adjudication of findings.
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 is not applicable. The device is a "Diode Laser Hair Removal Systems for Medical Use." It is a treatment device, not an AI-powered diagnostic tool used by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical laser system for hair removal. While it contains software, the "standalone" performance described in the context of AI algorithms is not relevant here. The software plays a role in the user interface and system control, validated according to general software principles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international and national safety and performance standards for medical electrical equipment, laser products, and biocompatibility (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series). The functional aspects (wavelength, energy, frequency, cooling) were verified through bench testing against specified requirements. For the software, the "ground truth" was established by validating it against FDA Final Guidance-General Principles of Software Validation and IEC62304-2015 to ensure it does not raise unacceptable risks.
8. The sample size for the training set
This is not applicable/provided. The submission does not describe an AI model or machine learning algorithm that requires a "training set" of data in the typical sense. The software validation refers to the software embedded within the device, not a separate AI algorithm trained on a dataset.
9. How the ground truth for the training set was established
This is not applicable/provided as there is no mention of an AI training set in the document.
§ 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.