(140 days)
1550 nm: The Fraxel 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
The Fraxel DUAL 1550/1927 nm 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.
The provided text is a 510(k) summary for the Fraxel DUAL 1550/1927 nm Laser System. It focuses on demonstrating substantial equivalence to predicate devices for expanded indications of the 1927 nm laser.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of specific metrics (e.g., success rates, percentage improvement). Instead, the acceptance criterion for regulatory clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices and that expanded indications do not raise new issues of safety and effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Substantial Equivalence | "A clinical study was conducted to support a determination of substantial equivalence to the predicate device, the Fraxel DUAL 1550/1927 Laser System (K101490)." |
| Safety and Effectiveness for New Indications | "The clinical performance data confirmed that the Fraxel DUAL 1550/1927 Laser System performs as intended and that the expansion of the new 1927 nm indications do not raise new issues of safety and effectiveness." |
Study Description:
A "clinical study" was conducted. The primary goal of this study was to:
- Confirm that the Fraxel DUAL 1550/1927 nm Laser System performs as intended.
- Demonstrate that the expanded indications for the 1927 nm laser do not introduce new safety and effectiveness concerns compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "A clinical study was conducted" but does not specify the sample size for this study.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information regarding:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's performance against a predicate, not how human readers' performance improves with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical laser system for dermatological procedures, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.
7. The Type of Ground Truth Used
The document implies that "clinical performance data" was collected to confirm the device performs as intended and to assess safety and effectiveness for the expanded indications. However, it does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). In the context of a laser treatment for skin conditions, this would likely involve clinical assessments by dermatologists, possibly photographic documentation, and patient-reported outcomes, but the document does not elaborate.
8. The Sample Size for the Training Set
This device is a physical laser system, not an AI or machine learning algorithm that requires a "training set." Therefore, the concept of a training set does not apply.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a training set does not apply to this device.
§ 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.