(50 days)
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) 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.
The provided document is a 510(k) summary for the Fraxel II SR Laser System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a clinical study designed to meet them in the way a traditional clinical trial report would.
Therefore, the information requested in your prompt regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be fully extracted from the provided text. The document states that "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 is a general statement rather than a detailed report of a study meeting specific acceptance criteria.
However, I can provide what information is available and indicate what is not present.
Acceptance Criteria and Study for Fraxel II SR Laser System
Based on the provided 510(k) summary, the device's acceptance was predicated on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly the Fraxel SR Laser System (K050841). The primary "acceptance criteria" here is that the device performs "as clinically intended" and introduces "no new issues of safety and effectiveness" compared to the predicate.
The document does not detail specific quantitative acceptance criteria or a dedicated study with defined endpoints to "prove" the device meets these criteria in the way a pre-market approval (PMA) would require. Instead, it relies on the safety and performance of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (from K060310) |
|---|---|
| Substantial equivalence in Indications for Use to predicate devices. | "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." (Indication statements are listed in section 5). |
| Device performs as clinically intended (consistent with predicate). | "Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended..." |
| No new issues of safety and effectiveness introduced compared to predicate. | "...and that no new issues of safety and effectiveness are introduced." |
| Key technological characteristics (energy type, operating principle) are equivalent to predicate. | "Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System..." |
2. Sample size used for the test set and the data provenance
- The document states: "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel SR Laser System."
- Sample Size: Not specified for any particular test set. The statement refers to "studies" in plural, implying prior data.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to as "Reliant studies," implying they were conducted by the manufacturer, Reliant Technologies, Inc., which is based in Mountain View, CA, USA.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the 510(k) summary. The summary does not describe a clinical study in detail that would involve establishing a ground truth with a specific number of experts or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the 510(k) summary.
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. This document describes a laser system for dermatological procedures, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a hardware device (laser system) for direct treatment application by a medical professional, not an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not explicitly provided. The "clinical analysis" mentioned likely relied on clinical endpoints and physician assessments related to the effectiveness of the laser in treating the indicated conditions (e.g., reduction in wrinkles, lightening of pigmented lesions, improvement in skin texture), which would fall under outcomes data and expert clinical assessment.
8. The sample size for the training set
- This is not applicable as this is not an AI/machine learning device that utilizes a "training set" in the computational sense. The "clinical analysis" referenced for performance would be based on prior trials/studies of the Fraxel SR Laser System and other related devices, but specific sample sizes for these prior studies are not detailed here.
9. How the ground truth for the training set was established
- This is not applicable for the reasons stated in point 8.
§ 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.