(95 days)
The Reliant Laser System II is intended for use in:
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), melasma and dyschromia;
Skin resurfacing procedures.
The Fraxel 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 upper dermis. Device accessories include tip attachments.
This submission for the Fraxel SR Laser System (K050841) does not contain a specific study proving the device meets individual acceptance criteria in the format typically seen for AI-enabled devices or diagnostics. Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices.
Here's an breakdown based on the provided text, addressing the points you requested where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not list specific numerical acceptance criteria (e.g., minimum sensitivity, maximum false positive rate) or present a table of device performance against such metrics. The core argument for acceptance is based on substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate devices | "No new issues regarding safety or effectiveness" |
| Functions as clinically intended | "Functions as clinically intended" |
| Conformance to 21 CFR 1040 (Laser Product Regulations) | "Conforms to the requirements of 21 CFR 1040" |
| Effective for: |
- Coagulation of soft tissue | "Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended" |
| - Treatment of periorbital wrinkles | |
| - Photocoagulation of pigmented lesions | |
| - Skin resurfacing procedures | |
2. Sample Size Used for the Test Set and Data Provenance
The submission mentions "clinical investigations" and "clinical studies" but does not specify the sample size for any test set. It states: "Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended."
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "peer-reviewed publications and clinical investigations," which suggests a mix of existing literature and possibly some internal studies, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission references "clinical studies" but does not detail the methodology for establishing ground truth within those studies or the role/qualifications of experts involved. Given the nature of a laser system for dermatological procedures, the "ground truth" would likely be clinical outcomes observed by dermatologists, but the specifics are not elaborated upon.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1). This level of detail regarding study design and independent review of results is not present in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study, especially one involving AI assistance, was not mentioned or relevant to this 2005 submission for a laser device. The Fraxel SR Laser System is a physical device, not an AI or diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. As stated above, this is a physical laser device, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document implies the ground truth for device performance is based on clinical outcomes data from "clinical studies" and "peer-reviewed publications." For dermatological procedures like those listed, this would likely involve clinical assessments of improvements in skin conditions, reduction of wrinkles, or removal of lesions. However, the specific methodology for establishing this ground truth (e.g., scoring systems, objective measurements) is not detailed.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are typically associated with machine learning or AI models. This submission is for a medical device (laser system), not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the concept of a training set does not apply, neither does the method for establishing its ground truth.
Summary of Approach for this Device (K050841):
The regulatory strategy for the Fraxel SR Laser System in this 510(k) relied heavily on demonstrating substantial equivalence to existing predicate devices (Fraxel SR Laser System K043219, Palomar Starlux K033549, Sciton BBL System K032460). The manufacturer argued that:
- The technological characteristics and indications for use were similar.
- Differences did not raise new safety or effectiveness issues.
- The device complied with regulatory standards for laser products (21 CFR 1040).
- "Sufficient data" from clinical studies and peer-reviewed publications supported that the device functioned as intended and was safe and effective.
This approach is common for medical devices where a direct comparison to similar, already-approved devices can be made, rather than requiring extensive de novo clinical trials with detailed performance metrics against a rigorously established ground truth, as might be expected for novel diagnostic devices or AI solutions.
§ 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.