(297 days)
The Palomar Lux1540™ Handpiece is intended for use in: Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.
The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
The provided text is a 510(k) summary for the Palomar Lux1540™ Handpiece, which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of document typically focuses on comparing the new device's technical characteristics, intended use, and safety/effectiveness to existing devices, rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics of the device against those criteria.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, ground truth methods, and MRMC studies is not present in the provided document.
Here's an breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document instead frames acceptance in terms of "substantial equivalence" to predicate devices. This means the device is considered acceptable if its performance, as demonstrated by technical and safety data, is comparable to devices already cleared by the FDA for the same intended uses.
- Reported Device Performance:
- The document states: "The specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification."
- "The Lux1540 Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) premarket notification demonstrates that the Lux1540 Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."
In summary, the "acceptance criteria" here are met by demonstrating substantial equivalence, meaning the device's performance is deemed acceptable if it performs similarly to established, legally marketed predicate devices for the specified indications.
2. Sample Size Used for the Test Set and the Data Provenance
- Not explicitly stated in the provided text. 510(k) summaries for laser handpieces often rely on bench testing, electrical safety tests, biocompatibility, and optical performance specifications rather than large-scale clinical test sets with human subjects for performance evaluation in the same way an AI diagnostic device would. If clinical data was used, its details (sample size, provenance) are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not stated. This document does not describe a study involving human experts establishing ground truth for a test set in the context of an AI-driven diagnostic device. The evaluation is focused on the device's physical and technical characteristics, and its equivalence to predicates.
4. Adjudication Method for the Test Set
- Not applicable/Not stated. See point 3.
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, an MRMC comparative effectiveness study was not done (or at least, is not mentioned in the provided text). This type of study is specifically relevant for AI-powered diagnostic aids where human interpretation is involved. The Lux1540 Handpiece is a therapeutic laser device, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The Lux1540 Handpiece is a physical device that requires a human operator for its therapeutic function. It is not an algorithm that performs standalone analysis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly described. For a therapeutic laser device seeking 510(k) clearance, "ground truth" often refers to demonstrating that the device meets its technical specifications (e.g., wavelength, power output, spot size, pulse duration) and that these specifications are consistent with effective and safe operation for the stated indications, as supported by scientific literature and predicate device performance. It also relies on a comparative assessment against the known performance and safety profiles of predicate devices.
8. The Sample Size for the Training Set
- Not applicable/Not stated. As this is a physical therapeutic device and not an AI algorithm, there is no "training set" in the conventional machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not stated. See 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.