FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.

AI/ML Overview

The provided text describes the Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria from an AI/algorithm perspective.

This document is a traditional medical device 510(k) summary for a physical laser system, not for a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "ground truth," "MRMC study for AI improvement," and "standalone algorithm performance" are not applicable in the context of this specific regulatory submission.

Here's what can be extracted and what cannot:

Information from the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document only broadly states that "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles." Specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific patient satisfaction score) are not provided.
Reported Device Performance: Similarly, specific performance metrics are not provided. The document only offers a general statement about safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not provided.
Data Provenance: The document mentions "Clinical studies," implying prospective data collection on human subjects, but does not specify country of origin or whether it was retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept of "experts establishing ground truth" is typically associated with AI model validation where human experts label data. For a physical laser device for wrinkle treatment, the "ground truth" would likely be direct clinical observation by physicians, patient self-assessment, or possibly photographic analysis by a panel of evaluators. However, none of this detail is provided.

4. Adjudication method for the test set:

Not provided.

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 is a physical laser device, not an AI system being evaluated to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical laser device.

7. The type of ground truth used:

The document implies the ground truth was based on clinical outcomes relevant to "safety and effectiveness for the treatment of facial wrinkles." This would likely involve physician assessment, possibly patient questionnaires, and potentially photographic evidence, but specifics are not given. It is not pathology or genetic data.

8. The sample size for the training set:

Not applicable / not provided. The concept of a "training set" applies to machine learning models, not typically to the direct development and testing of a physical medical device. While there were clinical studies, they are not referred to as a "training set" in this context.

9. How the ground truth for the training set was established:

Not applicable / not provided.

In summary of what is available from the document:

Device Type: Laserscope Lyra™ Surgical Laser System & Accessories (Nd:YAG laser)
Intended Use: Dermatological applications for the treatment of facial wrinkles.
Performance Claim: "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles."
Nonclinical Data: None mentioned for this specific submission, likely relying on prior predicate device data for engineering performance.
Clinical Data: Yes, clinical studies were performed to support safety and effectiveness. However, no details about the study design, sample size, specific endpoints, or results are included in this 510(k) summary.

This 510(k) summary serves to establish substantial equivalence to predicate devices, and as such, often omits the granular detail of clinical study results that would typically be found in a full clinical study report or a PMA submission requiring more extensive evidence.

Summary

Regulation Number and Section

§ 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.