(361 days)
The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows:
1410 nm Indications for Use:
- Fractional skin resurfacing procedures
1927 nm Indications for Use - Fractional skin resurfacing procedures
LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously - Fractional skin resurfacing procedures
The Lumenis YandR Laser System consists of:
- System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts)
- Operator control panel with touch-screen technology (GUI)
- NAFR handpiece and single-use removable tips
- Footswitch and other laser safety accessories
The non-ablative fractional NAFR handpiece emits two wavelengths - 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.
The Lumenis Y&R Laser System is intended for fractional skin resurfacing procedures using 1410 nm, 1927 nm, or a combination of both wavelengths (LPTT mode).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic or AI device would typically have. Instead, the "acceptance criteria" are implied through the successful demonstration of:
- Safety and effectiveness comparable to predicate devices.
- Expected wound healing responses.
- Compliance with relevant standards and regulatory requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Comparable to Predicate Devices | The Lumenis Y&R Laser System is deemed "as safe and effective as the predicate devices." This is supported by: Similar technological characteristics and principles of operation. |
| Expected Wound Healing Response (Histology) | 1410nm, 1927nm, and LPTT modes: Histology study on porcine animals showed "expected results for wound healing."Histology results "complied with the FDA requirements at 0, 1, 7, and 14 days after treatment."By day seven after radiation, all treatment sites for all treatment modes were "covered with an intact epidermal layer (Reepithelization).""No adverse events or unexpected complications were detected in the swines."LPTT Mode Specific: "No relevant differences in either the initial shape of the incursion into the skin or in wound healing" when compared to single wavelengths."No overlapping lesions were noted in LPTT treated sites and there was always normal skin tissue between two lesions when present." |
| Functionality as Intended | "In all instances, the Lumenis YandR Laser System functioned as intended and the results observed were as expected." |
| Compliance with Relevant Standards | The device was tested against: IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for safety)IEC 60601-1-2 (Electromagnetic Compatibility)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, requirements and user's guide)ISO 10993-1 (Biological evaluation of medical devices)IEC 62304 (Medical Device Software)ISO 14971 (Risk Analysis) |
| Verification and Validation of Software and Performance | "Software verification and performance validation testing were performed." |
| Technical Characteristics Substantial Equivalence to Predicates | The technical characteristics are "substantially equivalent to the predicate devices." Some differences in power, tip size, and pulse repetition rate were found to be acceptable due to confirmed wound healing responses. The LPTT mode, while novel, was justified through histology testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Three (3) female Yorkshire Cross crossbred swine were used for the histology study.
- Data Provenance: The study was conducted by Lumenis Inc. (the manufacturer), and the results were provided to the FDA. The country of origin for the data is not explicitly stated, but as Lumenis Inc. is based in Salt Lake City, UT, USA, and the submission is to the FDA, it is likely the study was conducted in the USA or under protocols recognized by a US-based manufacturer. The study was prospective in the sense that animals were treated and then observed over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of experts used for establishing "ground truth" for the histology study. The histopathology analysis was performed, but who specifically read the slides or confirmed the findings (e.g., a board-certified veterinary pathologist) is not detailed.
4. Adjudication method for the test set
The document does not describe an adjudication method for the histopathology findings in the context of multiple readers. The analysis seems to be presented as a single set of conclusions from the study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The study conducted was a histology study on porcine animals to assess wound healing and tissue response, not a human reader performance study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a laser system for medical procedures, not an AI/algorithm-only diagnostic or analytical tool. Therefore, the concept of a "standalone" algorithm performance study (without human-in-the-loop) is not applicable here.
7. The type of ground truth used
The ground truth for the study was based on histopathology analysis of skin tissue samples from the treated porcine animals, examined at different time points post-treatment (0, 1, 7, and 14 days). This involved examining the microscopic structure of the tissue, including re-epithelization, and confirming the non-ablative nature of the device.
8. The sample size for the training set
This device is not an AI/machine learning algorithm requiring a separate training set. The study describes device validation, not algorithm training. Therefore, there is no "training set sample size" in this context.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this question is not applicable.
§ 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.