(165 days)
The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
The Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.
The Lux1540 Handpiece & Lux1440 Handpiece each attach to the StarLux Pulsed Light and Laser Systems. The complete StarLux System console consists of a power supply, chiller, electronics, portable cart, and a footswitch.
The provided document is a 510(k) summary for the Palomar Lux1540 and Lux1440 Fractional Laser Handpieces. It details the device's intended use and claims substantial equivalence to predicate devices. However, it does not describe specific acceptance criteria or an analytical study proving the device meets those criteria in the way typically expected for performance claims like sensitivity, specificity, or reader study results.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that, rather than conducting new performance studies against pre-defined acceptance criteria, the manufacturer argues that their device is as safe and effective as devices already on the market.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's an attempt to answer based on the available information, noting what cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission hinges on "substantial equivalence" rather than quantitative performance against specific acceptance criteria. The document states: "The specifications and indications for use of the Lux1540 Handpiece &Lux1440 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) Premarket Notification."
2. Sample size used for the test set and the data provenance
This information is not provided in the document. As the submission relies on substantial equivalence and a comparison to predicate devices rather than a de novo performance study, details about a test set and its provenance are not included.
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. There is no mention of a test set with established ground truth by experts.
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
There is no mention of an MRMC study. This device is a laser handpiece, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical laser handpiece, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided as there is no specific performance study against a defined ground truth mentioned in the document.
8. The sample size for the training set
This information is not provided. As the submission is for substantial equivalence of a physical device, a "training set" in the context of an algorithm or AI is not relevant.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device and submission.
Summary based on the document:
The device's acceptance criteria and proof of meeting them are established through the process of substantial equivalence to existing predicate devices (Lux1540 Fractional Laser Handpiece K080244, Lux 1440TM Fractional Laser Handpiece K073583, and Fraxel Re:store™ Laser System (Formerly SR1500) K070284). The manufacturer asserts that "The Lux1540 Handpiece and Lux1440 Handpiece are 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 and Lux1440 Handpiece also share the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."
This means that the "study" proving the device meets its "acceptance criteria" is the 510(k) Premarket Notification submission itself, which argues that the new device is as safe and effective as the predicate devices based on a comparison of their characteristics, rather than new, independent performance studies with detailed acceptance metrics.
§ 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.