(69 days)
The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The MYTHOS 500™ system delivers pulsed infrared laser light with a 810nm±10% wavelength and a selectable fluence of 5-60J/cm2. The system enables two pulse modes: Long pulse and Pulse. The pulsed energy is delivered through a 10x12mm handpiece tip. The complete system consists of console and a handpiece connected to the system by an umbilical cord. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output the system requires simultaneous activation of the handpiece trigger and the footswitch. The handpiece tip is cooled to provide continuous skin cooling. Laser parameters and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.
The provided text describes the 510(k) summary for the MYTHOS 500™ Diode Laser System, which is intended for hair removal and permanent hair reduction. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the context of diagnostic accuracy (like sensitivity, specificity, or AUC) typically seen for AI/ML devices.
Therefore, many of the requested sections related to acceptance criteria, specific study designs, training/test set details, and expert ground truth establishment are not applicable or not provided in this type of submission. This document primarily addresses regulatory compliance, safety, and equivalence to a previously cleared device.
Here's a breakdown of the information that can be extracted or inferred, and what is not present:
Acceptance Criteria and Device Performance
The submission does not present acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be typical for an AI-enabled diagnostic device. Instead, "acceptance criteria" are implied by adherence to regulatory standards and demonstration of substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use/Indications for Use: Must be substantially equivalent to predicate device. | The MYTHOS 500™'s intended use and indications for use ("hair removal and permanent hair reduction; for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin") were previously cleared by FDA for the predicate device (LightSheer™). |
| Technical Characteristics: Must be similar to predicate device. | "The technical characteristics of the MYTHOS 500™ are similar to those of the LightSheer™." The MYTHOS 500™ delivers pulsed infrared laser light with an 810nm±10% wavelength and a selectable fluence of 5-60J/cm2, similar to the predicate. |
| Laser Output Values: Must be within previously cleared values of predicate device. | "Laser output values of the MYTHOS 500™ are well within previous cleared values of the LightSheer™." |
| Safety and Performance Testing: Must comply with relevant standards. | The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products. It also complies with European Medical Directive 93/42/EEC and voluntary standards IEC 60601-1, IEC 60601-1-2, IEC-60825-1, and IEC 601-2-22. |
Study Details (as inferable from the document)
This submission is a 510(k) premarket notification for a laser device, not an AI/ML diagnostic or prognostic tool. Therefore, a "study" in the sense of clinical trials to establish diagnostic performance against ground truth is not described or required for this type of submission focused on substantial equivalence. The "study" here refers to the engineering, performance, and safety testing to demonstrate that the device meets its specifications and is comparable to the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This information is not provided. The document states "Safety and performance testing" was conducted, but it does not detail specific clinical test set sizes, patient demographics, or data provenance. This is typical for a laser device submission focused on technical specifications and equivalence.
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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):
- N/A. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "truth" for a laser device is its adherence to technical specifications, safety standards, and its ability to achieve the intended physical effect (hair removal). These aspects are typically verified through engineering tests, not expert consensus on medical images or patient outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as there is no mention of a test set requiring adjudication in the context of diagnostic accuracy.
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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:
- N/A. This device is a standalone laser system, not an AI-assisted diagnostic tool. Therefore, no MRMC study, human reader comparison, or AI-assistance effect size is relevant or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in concept. The "standalone" performance here refers to the device's technical specifications and functionality, separate from a human operator's skill in applying it. The device itself (the laser, its wavelength, fluence, pulse modes) is tested for its intrinsic performance and safety. There is no "algorithm" in the sense of AI/ML.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical specifications, safety standards, and predicate device parameters. For a laser device, the "ground truth" would be the measured physical output (e.g., wavelength, fluence, pulse duration, temperature of cooling tip) against its stated specifications, and comparison against the known performance characteristics of the predicate device (LightSheer™). Compliance with regulatory and voluntary standards (21 CFR 1040.10, 1040.11, IEC 60601 series) serves as a form of "ground truth" for safety and basic performance. Long-term "outcomes data" to prove permanent hair reduction beyond what was shown for the predicate device would typically not be part of the 510(k) submission for substantial equivalence if the predicate's claims are adopted.
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The sample size for the training set:
- N/A. There is no "training set" in the context of machine learning. The device is a hardware product.
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How the ground truth for the training set was established:
- N/A. There is no "training set" or corresponding ground truth establishment process for this type of medical device submission.
§ 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.