(326 days)
The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.
The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: Skin resurfacing
The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components: Thermo-XEL Handpiece body. Adapter attachments: CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system
The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.
This document is a 510(k) premarket notification for the Alma Lasers Family of Thermo-XEL Handpieces, submitted to the FDA in 2008. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and met specific acceptance criteria for a new, novel device performance claim. Therefore, much of the requested information regarding acceptance criteria and performance studies is not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for this 510(k) submission.
This document is a "substantial equivalence" claim. For devices pursuing substantial equivalence, the primary "acceptance criterion" is that the device is as safe and effective as a legally marketed predicate device. This is typically demonstrated through comparing indications for use, operating principles, technological characteristics, and performance data if relevant to the comparison, rather than establishing and meeting novel performance metrics.
The document states: "The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices." It also explicitly mentions: "The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Family of Thermo-XEL Handpieces is substantially equivalent to the predicate devices."
Therefore, the "reported device performance" is implicitly that it performs equivalently to the listed predicate devices in terms of its intended use (ablation, vaporization, and coagulation of soft tissue for skin resurfacing) when attached to compatible CO2 and Er:YAG laser systems. No specific quantitative performance metrics or acceptance criteria are defined or reported.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this 510(k) submission.
This submission does not detail specific "test sets" or clinical studies with human subjects, as it relies on substantial equivalence to predicate devices. The "data provenance" mentioned would refer to the characteristics and performance of the predicate devices already on the market.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided in this 510(k) submission.
There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided in this 510(k) submission.
There is no mention of a test set requiring adjudication.
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
Not applicable.
This device is a laser handpiece, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
This device is a physical medical instrument (laser handpiece), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in this 510(k) submission.
As no specific study with a test set requiring ground truth is described, this information is not present. The "ground truth" for a substantial equivalence determination largely rests on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable/Not provided in this 510(k) submission.
There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of this device would rely on engineering principles, materials testing, and performance testing against established safety standards rather than a data-driven training set.
9. How the ground truth for the training set was established
Not applicable/Not provided in this 510(k) submission.
As there is no training set, this information is not available.
Summary of this 510(k) context:
This 510(k) submission (K072182) for the Alma Lasers Family of Thermo-XEL Handpieces is a regulatory filing that seeks to demonstrate "substantial equivalence" to pre-existing, legally marketed predicate devices. This pathway does not typically require the detailed clinical studies, acceptance criteria, and performance metrics that would be associated with a novel device or an AI/software device. Instead, the manufacturer compares the new device's indications for use, design, and technological characteristics to those of predicate devices to establish that it is "as safe and effective" as those already on the market. Therefore, the specific types of performance data, test sets, and ground truth methodologies you've requested are generally not found in this type of submission.
§ 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.