(59 days)
The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.
The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.
The provided text is a 510(k) Summary for the Palomar Medical Technologies, Inc. Artisan™ Aesthetic System. It generally focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics.
Based on the information provided in the document:
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Table of acceptance criteria and the reported device performance:
The document does not report specific acceptance criteria or quantitative device performance metrics from a clinical study. The submission relies on establishing substantial equivalence to predicate devices. The "Performance Data" section states: "The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device."Without specific study results, a table of acceptance criteria and reported performance cannot be generated from this document.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention any specific clinical study data (test set, sample size, or data provenance). The submission focuses on technical characteristics, intended use, and equivalence to predicate devices. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no specific clinical study data or test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Since no clinical study with a test set is described, no adjudication method is mentioned. -
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 document describes a light and laser system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers. Therefore, no MRMC comparative effectiveness study or related effect size for human readers improving with AI is mentioned or relevant to this submission. The device is a direct treatment system, not an AI-based analysis tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a physical light and laser system for medical procedures, not an algorithm. Therefore, the concept of "standalone algorithm-only performance" does not apply to this device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As no specific clinical study results are presented, no information on the type of ground truth used is available. The substantial equivalence argument relies on the safety and effectiveness of the predicate devices. -
The sample size for the training set:
Since this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in that context is not applicable or mentioned in this document. -
How the ground truth for the training set was established:
As the concept of a training set is not applicable to this device type and submission, no information is provided on how ground truth for a training set was established.
In summary, the provided 510(k) Summary emphasizes substantial equivalence to predicate devices based on shared technological characteristics, mechanism of action, intended use, and physical properties. It does not contain information about specific clinical study data, acceptance criteria, or performance metrics in the format requested, as it is not a submission for a novel AI/software-driven diagnostic or therapeutic device evaluated through a performance study with explicit ground truth and sample sizes.
§ 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.