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The Reliant Laser System II consists of a set of fiber lascrs, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal cnergy to the cpidermis and upper dermis. Device accessories include tip attachments and pre-treatment solution.

AI/ML Overview

The provided text is for a Premarket Notification (510(k)) for the Reliant Laser II System and Accessories, specifically for a labeling change. It asserts substantial equivalence to predicate devices and describes the device, its indications for use, and a conclusion about its safety and effectiveness.

However, the document does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented to prove the device meets acceptance criteria in the way a diagnostic AI device submission would. This 510(k) focuses on a labeling change and relies on previous clearances and clinical analysis performed on non-significant risk and IDE Reliant studies to support the change in the language of the indications for use statement, rather than presenting a new study with explicit performance metrics.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text because such information is not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not explicitly defined in this document. The document asserts the device "performs as clinically intended" and that "no new issues of safety and effectiveness are introduced" due to the labeling change.	Not explicitly defined in this document. The document states that "Sufficient safety and efficacy data has been gathered" from prior studies to support the change in indications for use. Specific performance metrics (e.g., success rates for wrinkle reduction, lesion clearance, or complication rates with numerical values) are not provided in this 510(k) summary.

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

Sample Size: Not specified in this document. The document refers to "Non-Significant Risk and IDE Reliant studies" as the source of clinical analysis, but does not provide details on their sample sizes or methodologies.
Data Provenance: Not specified. The document vaguely refers to "Reliant studies," implying internal company studies, but no information on country of origin or whether they were retrospective or prospective is given here.

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

This information is not provided in the document. The document refers to "clinical analysis" and "clinical evaluation" but does not detail the methodology for establishing ground truth or the involvement of experts in these studies.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this submission. The device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.

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

This is not applicable as the device is a laser system, not an algorithm.

7. The type of ground truth used

This is not explicitly stated. Given it's a dermatological laser for treatments like wrinkle reduction and lesion photocoagulation, the ground truth would likely involve clinical assessments of treatment outcomes (e.g., photographs, qualitative/quantitative scales for wrinkle severity, lesion clearance, skin texture improvements, and histology for tissue coagulation if applicable). However, the document does not specify how ground truth was established for the underlying studies.

8. The sample size for the training set

This is not applicable as the device is a physical laser system, not a machine learning algorithm requiring a "training set."

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

This is not applicable for the same reason as above.

Summary of Device and its Purpose (from the text):

The Reliant Laser II System (Fraxel SR Laser System) is a laser surgical instrument intended for dermatological procedures. This 510(k) is for a labeling change, expanding its indications for use to include:

Dermatological procedures requiring the coagulation of soft tissue.
Treatment of periorbital wrinkles.
Photocoagulation of pigmented lesions (lentigos, solar lentigos, dyschromia).
Skin resurfacing procedures.

The submission asserts "substantial equivalence" to predicate devices and states that "Sufficient safety and efficacy data has been gathered" from prior "Non-Significant Risk and IDE Reliant studies" to support the expanded indications. However, the details of these studies and their specific performance metrics are not included in this document.

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