(203 days)
The Fraxel III SR Laser System and accessories is intended for use in:
Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
This 510(k) summary describes a Fraxel III SR Laser System (Fraxel re:pair™) for dermatological procedures. It doesn't contain information about a study with acceptance criteria and a reported device performance table as would be typical for an AI/ML device submission. Instead, it relies on substantial equivalence to predicate devices and clinical data from non-significant risk and investigational device exemption studies to support its safety and effectiveness.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. This submission is for a medical device (laser system), not an AI/ML diagnostic or predictive tool, and thus the structure of its performance evaluation is different. Performance is asserted based on clinical intent and no new safety/effectiveness issues, rather than statistical metrics against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided. The document states:
"Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System."
"Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories."
Without access to the actual study reports, details on sample sizes, patient demographics, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodologies for these underlying clinical studies are unavailable in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The assessment relies on the overall clinical performance demonstrated in the aforementioned studies, but the role of experts for "ground truth" as you'd define it for an AI model is not detailed here. The clinical evaluation implicitly involves medical professionals, but their specific role in establishing "ground truth" for a test set is not described.
4. Adjudication Method for the Test Set
This information is not provided. As this is not an AI/ML submission where a ground truth is established for a test set through human review, an adjudication method for such a test set is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for AI/ML diagnostic tools where the impact of AI assistance on human readers is being evaluated. This submission is for a therapeutic laser device.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
A standalone performance study is not applicable and therefore not mentioned. This device is a laser system; its "performance" is inherently tied to its application by a trained medical professional. It does not operate as an algorithm independently.
7. The Type of Ground Truth Used
The concept of "ground truth" as applied to AI/ML models is not directly applicable or discussed in this document. The "ground truth" for a therapeutic device's effectiveness would be clinical outcomes observed in patients (e.g., reduction in wrinkles, successful soft tissue ablation), as determined by medical professionals in the clinical studies. The summary states that "The device performed as clinically intended with no new issues of safety and effectiveness introduced."
8. The Sample Size for the Training Set
This information is not provided. The concept of a "training set" in the context of machine learning is not relevant to this submission, which is for a hardware device (laser system). The "training" here would refer to the engineering and development of the laser itself and clinical trials involving patients.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Again, the concept of "ground truth for a training set" as used for AI/ML models is not directly applicable to a therapeutic laser device. The "ground truth" in device development relates to engineering specifications and clinical efficacy/safety observed in product development and clinical trials.
§ 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.