(60 days)
The MultiWave XR Laser System is indicated for the following uses:
- The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face.
- The 755 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for I-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
- The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.
The MultiWave XR combines three laser outputs in a single device. It produces a long pulse laser light of 532 nm, 755 nm, and 1064 nm wavelengths. The laser head has two optical cavities containing an Alexandrite crystal rod (755 nm) and a Nd:YAG crystal rod (1064 nm) with optional frequency doubler installed (532 nm). Pulsed laser energy accomplished with a red aiming beam of low energy (5mW, 635nm) is delivered to a target via an optical fiber and a handpiece. Each laser outlet has own fiber and handpiece. Chilled air is delivered to the same target via jets in a handpiece.
This 510(k) submission for the MultiWave XR laser system does not contain the detailed, quantitative acceptance criteria and study data typically found in clinical validation reports for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) cannot be directly addressed from the provided text.
Here's an attempt to extract and describe what is available, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
This document does not present explicit "acceptance criteria" in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding quantitative results for the MultiWave XR itself. The "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices for the specified indications for use.
The "reported device performance" is essentially that it achieves similar therapeutic effects (permanent hair removal, treatment of vascular lesions, pigmented lesions, and wrinkles) as the predicate devices, as it shares identical technological characteristics and intended uses.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Implied by Equivalence) |
|---|---|
| Technological Equivalence: Flash lamp pumped Nd:YAG laser rod (1064 nm), Alexandrite laser rod (755 nm), optional frequency doubler (532 nm), optical fiber delivery system, aiming pilot lasers, microprocessor controlled, closed water-air cooling system. | MultiWave XR possesses these identical technological characteristics. |
| Intended Use Equivalence: Permanent hair removal, treatment of vascular lesions, pigmented lesions, and wrinkles. (Specific wavelengths for specific uses detailed in Indications for Use). | MultiWave XR is indicated for these same uses for its respective wavelengths. |
| Safety and Effectiveness: Does not raise new questions of safety and effectiveness compared to predicates. | The risk and benefits of the MultiWave XR laser system are comparable to the predicate devices when used for similar applications. No new questions of Safety and Effectiveness are raised. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) relies on substantial equivalence to existing predicate devices, not on a new clinical study with a test set of patient data from a specific provenance. The "test set" in this context refers to the comparison of the device's design and intended use against those of the predicate devices.
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)
Not applicable. Ground truth, in the context of clinical studies for AI/ML, isn't established here. The "ground truth" for this submission would be the FDA's prior clearance of the predicate devices, and the established safety and effectiveness of those technologies as understood by general medical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical adjudication of patient cases described in this 510(k) submission.
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
Not applicable. This device is a laser system, not an AI/ML-driven diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (laser system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for a new clinical study. The "ground truth" is the established safety and effectiveness of the predicate devices based on their prior FDA clearances and established clinical use.
8. The sample size for the training set
Not applicable. This pertains to AI/ML models, not a physical laser device.
9. How the ground truth for the training set was established
Not applicable. This pertains to AI/ML models, not a physical laser 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.