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Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

• · Dermatology
• · Cosmetic surgery
• · Plastic and general surgery
• · Oral surgery
• · Gynecology
• · Otorhinolaryngology
• · Podiatry

The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.

The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.

This document is a 510(k) summary for the Lite Touch™ Er YAG Laser Treatment System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to prove device performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for an AI/device performance study (e.g., sensitivity, specificity, or accuracy targets). Instead, it focuses on demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device based on technological characteristics.

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

This document describes a medical device clearance process based on demonstrating substantial equivalence to a predicate device and compliance with standards, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable and not provided.

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

Not applicable, as this is not a study requiring a ground truth established by experts on a test set of data.

4. Adjudication method for the test set

Not applicable.

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 an Er:YAG laser system for surgical procedures, not an AI diagnostic tool that assists human readers.

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

Not applicable. The Lite Touch™ is a surgical tool, operated by a physician.

7. The type of ground truth used

Not applicable in the context of clinical performance evaluation studies for AI/diagnostic devices. The "ground truth" here is the device's adherence to engineering specifications and safety standards, and its perceived equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a 'training set.'

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

Not applicable.

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