(99 days)
1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
The Fraxel re:store® Dual Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) submission for the Fraxel re:store® Dual Laser System. For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a previously legally marketed predicate device. This means the new device must be as safe and effective as the predicate device.
The study presented focuses on demonstrating the safety and efficacy of the 1927 nm wavelength for the treatment of actinic keratosis, which is an added indication compared to the predicate device.
Given this, the acceptance criteria and reported device performance can be summarized as follows:
| Acceptance Criterion (for 1927 nm wavelength for Actinic Keratosis) | Reported Device Performance |
|---|---|
| Safety: Device operation does not introduce new safety concerns. | Histological analysis demonstrated the safety. Side effects were minimal and well tolerated in clinical studies. |
| Efficacy: Device effectively treats actinic keratosis. | Clinical studies demonstrated efficacy in the treatment of actinic keratosis. |
| Substantial Equivalence: Device is as safe and effective as the predicate device for its stated indications, and for the new indication, demonstrates comparable safety and efficacy. | Demonstrated that the Fraxel re:store Dual® Laser System performs as intended and that no new issues of safety and effectiveness are introduced. Concluded to be substantially equivalent to predicate devices. |
Study Details:
The provided text describes both pre-clinical and clinical studies.
2. Sample size used for the test set and the data provenance:
- Pre-clinical Study:
- Sample Size: Not explicitly stated as a number, but involved "pig skin and excised human abdominal tissue."
- Data Provenance: Not specified (e.g., country of origin). The phrase "excised human abdominal tissue" suggests human tissue samples, likely from a tissue bank or surgical waste.
- Clinical Study:
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Given it's a clinical study for product clearance, it's highly likely to be a prospective study.
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 text. The histological analysis would have been performed by pathologists/histologists, and the clinical efficacy and safety would have been assessed by dermatologists or other qualified medical professionals, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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 device is a laser system for dermatological procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and 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:
- Again, this device is a laser system, not an algorithm or AI. Standalone algorithmic performance is not applicable here. The device's performance is intrinsically linked to its direct physical interaction with tissue, potentially guided by human operators.
7. The type of ground truth used:
- Pre-clinical Study:
- Histological analysis: The ground truth for lesion characteristics (depth and width) was established directly through microscopic examination of tissue.
- Clinical Study:
- Clinical assessment: The ground truth for safety and efficacy in treating actinic keratosis was based on clinical observations and assessments by medical professionals, likely involving visual inspection, possibly biopsies, and patient reported outcomes.
8. The sample size for the training set:
- This information is not applicable as the document describes a medical device (laser system) and its performance studies, not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable as described 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.