(143 days)
The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of surgical scars and acne 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 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.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular criteria in terms of numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.
However, based on the Clinical Performance Data section, we can infer the overarching acceptance criteria and the nature of the study:
Inferred Acceptance Criteria:
The primary acceptance criteria were that the Fraxel SR Laser System:
- Functioned as clinically intended.
- Performed as clinically intended.
- Introduced no new issues of safety and effectiveness compared to predicate devices.
Study that Proves the Device Meets Acceptance Criteria:
A "clinical investigation" was conducted.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions as clinically intended | "The Fraxel SR Laser System functioned as clinically intended." |
| Device performs as clinically intended | "The Fraxel SR Laser System performs as clinically intended" |
| No new safety/effectiveness issues | "no new issues of safety and effectiveness are introduced." |
| Substantially equivalent to predicates | "The Fraxel SR Laser System is substantially equivalent to the devices currently marketed..." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text only mentions "Clinical performance data was used" and "The results from clinical investigation."
- Data Provenance: Not explicitly stated. It is a "clinical investigation," which typically implies prospective data from human subjects. However, the country of origin is not mentioned.
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 document. The type of "clinical investigation" and how effectiveness was judged (e.g., by experts) is not detailed.
4. Adjudication method for the test set:
This information is not provided in the document.
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:
This is not applicable. The device is a "Dermatology Laser" system, not an AI software intended for interpretation by human readers. Therefore, an MRMC study and effect size for human reader improvement with AI assistance are not relevant to this device's evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This is not applicable. The Fraxel SR Laser System is a physical laser device used by a clinician, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document mentions "clinical investigation" and demonstrating that the system "functioned as clinically intended" and "performs as clinically intended." This strongly suggests that clinical outcomes data (e.g., observed changes in skin, reduction in wrinkles/scars, efficacy in pigmented lesion treatment) were used. Pathology might be relevant for some indications but is not explicitly stated as the ground truth method.
8. The sample size for the training set:
The document describes a "clinical investigation" for performance data. It does not mention a "training set" in the context of machine learning, as this is a physical device, not an AI algorithm. Therefore, "training set" information is not applicable.
9. How the ground truth for the training set was established:
As explained in point 8, a "training set" in the machine learning sense is not applicable to this device description.
§ 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.