(243 days)
The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue
The ResurFX module is a 1565nm non ablative laser module that is an add-on to FDA cleared mainframes like the M22 (LUM 2, cleared under K083733).
The ResurFX module is constructed of: 1565nm fiber laser Scanner and scanner controller Power Supply Cooling unit Treatment handpiece The system may be activated by either handpiece or footswitch trigger.
The provided document describes the Lumenis ResurFX laser module, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML device approval (e.g., sensitivity, specificity, or reader study results).
Instead, the submission focuses on:
- Bench performance tests: To ensure the device performs its intended use safely and efficiently.
- Histological analysis: To align delivered energy with coagulation impact at the skin tissue level.
- Substantial Equivalence Argument: The core of the approval is based on the device being substantially equivalent to existing predicate devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System). This means comparing design, materials, technological characteristics, energy envelopes, and indications for use.
Therefore, many of the specific questions about acceptance criteria for an AI/ML algorithm and related study details cannot be answered from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML algorithm. The acceptance criteria for this device appear to be compliance with safety standards and functional performance as demonstrated through bench testing and histological analysis, and crucially, substantial equivalence to predicate devices.
- Reported Device Performance:
- Safety and Efficacy: Established by a series of performance tests, lab performance tests, design validation, and software verification and validation.
- Histological Analysis: Performed to align delivered energy with coagulation impact at the skin tissue level.
- Compliance with Standards:
- IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
- IEC 60601-1-2 (Electromagnetic compatibility (EMC)).
- IEC 60601-2-22 ed3.0:2007 (Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment).
- IEC 60825-1:2007 (Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide).
- Substantial Equivalence: The device has the same intended use and indications as its predicate devices. The technology and the envelope of power and frequency are covered by the predicate devices. Minor differences in human interface and accessories do not raise new safety/effectiveness issues.
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/Not provided: This document does not describe a clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and bench tests, and histological analysis, not a clinical trial with a patient sample size.
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/Not provided: No test set involving human expert ground truth for an algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided: No test set involving human expert adjudication is described.
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
- No: A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This device is a laser module for dermatological procedures, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The closest concept to "ground truth" here is the histological analysis performed to evaluate the coagulation impact at the skin tissue level, correlating delivered energy with physical tissue effect. This serves as a "ground truth" for the device's functional effect. However, it's not "ground truth" in the context of an AI study.
8. The sample size for the training set
- Not applicable/Not provided: This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not provided: This is not an AI/ML device, so there is no training set or associated ground truth establishment process described.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The "study" presented here is not a clinical trial or an AI performance study, but rather a submission demonstrating:
- Bench Performance Tests: These tests confirmed the Lumenis ResurFX performs its intended use safely and efficiently.
- Design Validation and Software Verification/Validation: These processes ensured the device meets its specifications.
- Histological Analysis: This analysis was crucial for correlating the laser's delivered energy with the expected coagulation impact on skin tissue.
- Compliance with International and Medical Device Standards: The device was tested and found to comply with relevant IEC standards for medical electrical equipment and laser safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 ed3.0:2007, IEC 60825-1:2007).
- Substantial Equivalence to Predicate Devices: The primary argument for approval is that Lumenis ResurFX is substantially equivalent to previously cleared devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System) in terms of intended use, indications, technology, and power/frequency envelopes. This implies that since the predicate devices are already deemed safe and effective, and the new device is functionally similar within accepted parameters, it also meets safety and efficacy criteria without needing new clinical studies. The document explicitly states: "Based on the equivalence with predicates, and on the histological analysis performed, Lumenis believes that clinical studies are not necessary to determine the safety and efficacy of the 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.