(108 days)
The Fraxel® SR 1500 Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures.
The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
The provided 510(k) summary for the Fraxel® SR1500 Laser System and Accessories does not contain information about acceptance criteria or a study proving its performance against such criteria in the manner typically expected for diagnostic AI/ML devices.
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices based on identical or similar indications for use and technological characteristics. This type of submission relies on the prior clearance of the predicate devices and argues that the new device does not introduce new issues of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or not provided in this specific 510(k) document.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Provided. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., sensitivity, specificity, accuracy, dice score, etc.) for the device. The "performance" mentioned refers to the device performing as clinically intended, which is a qualitative statement based on comparison to predicate devices, not specific metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Provided. This type of information is typically found in clinical studies, which are not detailed in this 510(k) summary for establishing performance against criteria. The "clinical performance data" mentioned is not described.
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 Provided. Since no specific test set or ground truth establishment process is described, information about experts is absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Provided. As no test set is detailed, no adjudication method is mentioned.
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 / Not Provided. The Fraxel® SR1500 Laser System is a physical laser device for dermatological procedures, not an AI/ML diagnostic or image interpretation tool designed to assist human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a laser system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Provided. No ground truth is described as the 510(k) focuses on substantial equivalence to predicate devices, not novel performance claims requiring new clinical validation data.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a laser system, generally not trained in the same way an AI/ML algorithm would be. The device itself is "controlled by an embedded processor" but the submission doesn't describe any machine learning training.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. See point 8.
Summary based on the Provided Text:
The 510(k) submission for the Fraxel® SR1500 Laser System and Accessories does not describe specific acceptance criteria or an analytical/clinical study to demonstrate performance against such criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Fraxel® II SR Laser Systems, Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) based on:
- Identical or similar indications for use.
- Identical key technological characteristics (energy type, operating principle) to at least one of its predicates (K062303).
The statement "The clinical performance data reviewed supported the determination that the Fraxel® SR1500 Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced" indicates that existing clinical data from the predicate devices, or potentially other general clinical understanding of fractional ablative lasers, was sufficient to support the substantial equivalence claim without requiring new, specific performance studies with defined acceptance criteria for this device itself.
§ 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.