(55 days)
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick 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.
The Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are two models included, EVOLUTION MEDICAL, M-I-X MEDICAL, the two models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm²), M-I-X MEDICAL (1-70 J/cm²).
The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device, which means the submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information typically associated with complex clinical studies and detailed acceptance criteria for AI/Software as a Medical Device (SaMD) is not present in this document.
However, I can extract the non-clinical acceptance criteria and the studies that verify them, as outlined in the document. The device in question is a physical laser device, not an AI-driven one, so many of the requested categories (like MRMC studies, ground truth for training data, etc.) are not applicable here.
Here's a breakdown of the available information regarding acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)2012 (Consolidated Text) | "Comply with ANSI/AAMI ES60601-1, IEC 60601-2-22" |
| (The document states compliance with the Electrical Safety standard for the proposed device, aligning with the predicate device's compliance.) | ||
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | "Comply with IEC 60601-1-2" |
| (The document states compliance with the EMC standard for the proposed device, aligning with the predicate device's compliance.) | ||
| Laser Safety | IEC 60601-2-22 Edition 3.1 2012-10, IEC 60825-1:2014 | "Comply with IEC 60601-2-22, IEC 60825" |
| (The document states compliance with Laser Safety standards for the proposed device, aligning with the predicate device's compliance.) | ||
| Biocompatibility - Cytotoxicity | ISO 10993-5 Third Edition 2009-06-01 | "No Cytotoxicity" |
| (The document states no cytotoxicity for the proposed device, aligning with the predicate device's performance.) | ||
| Biocompatibility - Sensitization | ISO 10993-10 Third Edition 2010-08-01 | "No evidence of sensitization" |
| (The document states no evidence of sensitization for the proposed device, aligning with the predicate device's performance.) | ||
| Biocompatibility - Irritation | ISO 10993-10 Third Edition 2010-08-01 | "No evidence of irritation" |
| (The document states no evidence of irritation for the proposed device, aligning with the predicate device's performance.) | ||
| Energy Output Accuracy | (Implicitly, to meet design specifications) | "Performance Testing for Energy Output Accuracy." |
| (Test was conducted, and implicitly, the device met the required accuracy for its specified fluence ranges: EVOLUTION MEDICAL: 1-77 J/cm²; M-I-X MEDICAL: 1-70 J/cm²). The comparison table highlights that the proposed device's fluence range is 'Similar' to the predicate, and analysis states these differences "will not affect the safety and effectiveness". | ||
| Software Verification & Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | "Software Verification and Validation Testing was conducted... and the level of concern was determined to be Moderate for the proposed device." |
| (Implies the software meets the necessary requirements for safety and functionality.) |
2. Sample size used for the test set and the data provenance
This information is not applicable as the document describes a physical laser device, not a diagnostic or AI device with a "test set" in the typical sense of evaluating performance on a dataset of images or clinical cases. The "tests" mentioned are primarily engineering safety and performance tests on the device itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI systems; for this physical device, compliance is measured against engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in clinical studies or AI evaluations to establish a consensus ground truth from multiple readers/experts. This is not reported for the non-clinical tests of this device.
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. This describes a physical laser hair removal device, not an AI software intended to assist human readers. No MRMC study was performed or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical laser system, not a standalone algorithm. Its performance is evaluated through its physical output and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the established international standards (e.g., IEC 60601-1, ISO 10993-5) and the design specifications for parameters like energy output accuracy. For biocompatibility, the ground truth is the chemical and biological response observed in standardized tests on the material.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for this physical device.
§ 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.