(257 days)
The Diode Laser Hair Removal System 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 proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device are Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch.
The provided document is a 510(k) summary for a medical device (Diode Laser Hair Removal System). It describes the device, its intended use, and compares it to a legally marketed predicate device to demonstrate substantial equivalence.
However, the document does not contain information regarding detailed acceptance criteria for device performance, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in terms of efficacy or performance on hair removal.
Here’s a breakdown of why the requested information cannot be fully provided from the given text:
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Table of acceptance criteria and reported device performance: The document lists technical specifications for the proposed device and compares them to the predicate device (e.g., laser type, wavelength, spot size, fluence, frequency). However, it does not define specific acceptance criteria related to efficacy (e.g., "X% hair reduction in Y% of patients") nor does it present study data against such acceptance criteria. The "Remarks" column in Table 4 simply states "SE" (Substantially Equivalent) or "Discussion 1" if there's a difference in a parameter. "Discussion 1" clarifies that the proposed device's fluence range is within the predicate's, which doesn't equate to performance acceptance criteria.
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Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study data is presented. The document explicitly states: "No clinical study is included in this submission."
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical performance study requiring ground truth establishment is presented.
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Adjudication method for the test set: Not applicable, as no clinical performance study requiring adjudication is presented.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. The device is a laser hair removal system, not a diagnostic device requiring human reader interpretation or AI assistance in the same way.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
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The type of ground truth used: Not applicable, as no clinical performance study requiring ground truth is presented.
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The sample size for the training set: Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.
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How the ground truth for the training set was established: Not applicable, as this device does not involve machine learning or AI algorithms.
Summary of what the document does provide regarding acceptance and testing:
The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for approval. This typically involves showing that the new device has the same intended use, technological characteristics, and safety profile as a legally marketed device.
The non-clinical testing detailed in section 7 confirms that the device complies with relevant safety and electrical standards:
- IEC 60601-1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
- IEC 60825-1: Safety of laser products Part 1: Equipment classification and requirements
- IEC 60601-1-2: Electromagnetic compatibility
- ISO 10993-5: Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
- AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
The "acceptance criteria" here are implicitly the adherence to these standards and the demonstration of equivalent technical specifications (Table 4) and safety characteristics (Table 5) to the predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests that confirmed compliance with these standards and the comparison tables showing technical equivalence.
The document explicitly states "No clinical study is included in this submission." This means that the 510(k) clearance was based on demonstrating equivalence, not on providing new clinical performance data to meet specific efficacy acceptance criteria.
In conclusion, the document's purpose is to establish substantial equivalence based on technical specifications and safety standards, rather than proving performance against specific efficacy acceptance criteria via clinical trials.
§ 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.