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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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For use in hospitals, clinics, home use for the delivery of insulin to diabetics.

Lite Touch Syringes

The provided text is a clearance letter from the FDA for a device called "Lite-Touch Syringe." It does not contain information about the acceptance criteria, study details, or performance data of the device. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing it.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth used.
• Sample size for the training set or how its ground truth was established.

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The Lite Touch Erbium Laser Treatment System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.

The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.

This document, K974460, is a 510(k) summary for the Lite Touch Erbium Laser Treatment System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.

Therefore, the following information is largely not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided because no performance data was deemed required for this 510(k) submission. The submission states, "None. The specifications and intended uses of the Lite Touch Erbium Laser Treatment System are the same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

2. Sample size used for the test set and the data provenance: Not applicable, as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study was conducted.

4. Adjudication method for the test set: Not applicable, as no performance study was conducted.

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 system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used: Not applicable, as no performance study was conducted.

8. The sample size for the training set: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

Key takeaway from the document:

The regulatory strategy for the Lite Touch Erbium Laser Treatment System was to demonstrate substantial equivalence to already legally marketed predicate devices (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and Continuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium 2.94™ Systems). This approach meant that a new de novo performance study with specific acceptance criteria was not required by the FDA. The submission focused on comparing the specifications and intended uses of the new device to those of the predicate devices.

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