(107 days)
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin resurfacing I
- Treatment of wrinkles and rhytids .
- Treatment of furrows I
- Soft tissue ablation .
Not Found
I am sorry, but the provided text from the FDA 510(k) summary for the MedArt 620 Laser System does not contain the specific information required to address your comprehensive request regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary primarily focuses on:
- Substantial Equivalence Determination: This document confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices, based on its indications for use.
- Regulatory Information: It details the device's regulation number, name, class, product code, and relevant FDA regulations.
- General Controls: It reminds the applicant of obligations under general controls provisions (registration, labeling, GMP, etc.).
- Indications for Use: It clearly outlines the intended medical applications for the CO2 laser system in dermatology, plastic, and general surgery (skin resurfacing, treatment of wrinkles, furrows, soft tissue ablation).
- Contraindications: It specifies conditions for which the device should not be used (hard tissue dental applications, not evaluated as a fractionated scanner).
Missing Information:
The document does not include details about:
- Specific performance acceptance criteria for the device (e.g., specific thresholds for ablation depth, coagulation effectiveness, wrinkle reduction percentages).
- Any performance study, clinical trial, or validation report that would describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance (e.g., country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (not applicable for this type of laser device).
- Type of ground truth used (e.g., pathology, outcomes data).
- Training set sample size (not applicable for a physical laser device).
- How ground truth for the training set was established.
This is typical for a 510(k) clearance for a device like a surgical laser, where substantial equivalence is often demonstrated through adherence to recognized performance standards, engineering testing, and a comparison of features, materials, and intended use against a legally marketed predicate device, rather than a clinical study proving specific objective performance metrics with human readers or AI.
To obtain the kind of detailed study information you're asking for, you would typically need to review:
- PMA (Premarket Approval) applications: For novel, high-risk devices, which require extensive clinical data.
- Clinical Study Reports: Published literature, or data submitted as part of a 510(k) if the device presents new technological characteristics or different indications that warrant clinical data.
- Specific performance data submitted to the FDA: This is usually summarized in the 510(k) Decision Summary if available publicly, but not embedded in the initial clearance letter itself.
Therefore,Based on the provided text, I cannot answer your specific questions about the device's acceptance criteria and the study proving it meets those criteria.
§ 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.