(176 days)
The Fraxel II SR 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 of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
This document is a 510(k) summary for the Fraxel II SR Laser System and Accessories, which is a medical device. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text, focusing on the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or a table of device performance metrics that would be typically seen for software or AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC). This device is a laser system for dermatological procedures, and the "performance" is described more qualitatively in terms of its intended clinical effects.
However, based on the nature of the submission, the implicit "acceptance criteria" for the FDA's 510(k) clearance are:
| Acceptance Criterion (Implicit) | Reported Device Performance (as described) |
|---|---|
| Substantial Equivalence in Indications for Use | "Substantial equivalence for the Fraxel II SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements." |
| Clinical Performance (Safety and Effectiveness) | "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel II SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This implies the device safely achieves its intended dermatological effects (coagulation of soft tissue, treatment of wrinkles, scars, pigmented lesions, skin resurfacing) without introducing new risks compared to predicates. |
| Technological Characteristics Equivalence | "Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel II SR Laser System as described in submission K060310 and the Fraxel SR Laser System as described in submission K053047." |
| No New Issues of Safety and Effectiveness Introduced | "Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." |
| FDA Clearance (Overall "Acceptance") | The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates all implicit acceptance criteria for 510(k) clearance were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies". However, it does not specify the sample size for these studies, nor does it explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "IDE Reliant studies" typically implies prospective clinical trials conducted under an Investigational Device Exemption (IDE), which are generally prospective. "Non-Significant Risk studies" would also typically involve prospective patient enrollment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical studies. Given this is a laser system and not an AI diagnostic tool, the "ground truth" would likely be clinical outcomes assessed by treating physicians/dermatologists, rather than interpretation by a panel of reviewers.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with AI assistance. This is expected as the device described is a laser system for treatment, not an AI diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "Laser System," not an "algorithm" or AI. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this medical device. The system is operated by a human.
7. The Type of Ground Truth Used
While not explicitly stated as "ground truth," for a therapeutic laser system, the "ground truth" of its efficacy would be based on clinical outcomes data from patients treated with the device. This would involve assessments of the reduction in wrinkles, improvement in scars, clearance of pigmented lesions, and overall skin resurfacing effects as observed and documented by clinicians, and potentially patient satisfaction. Safety would be assessed by tracking adverse events.
8. The Sample Size for the Training Set
The document refers to "Non-Significant Risk and IDE Reliant studies" for clinical analysis. For a physical device like a laser, this represents the clinical validation set, not a "training set" in the context of machine learning. The device itself (the laser system) is not an AI algorithm that "learns" from data in the way a diagnostic AI would. Therefore, the concept of a "training set sample size" as typically understood for AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" and "ground truth for the training set" in the AI/ML sense is not applicable to this device. Clinical studies would establish the safety and efficacy of the device based on observed patient outcomes.
§ 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.