Search Results

The Fraxel II SR Laser System and accessories is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of acne scars and surgical scars;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;

Skin resurfacing procedures.

The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

This document is a 510(k) summary for the Fraxel II SR Laser System and Accessories, which is a medical device. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text, focusing on the requested acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a table of device performance metrics that would be typically seen for software or AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC). This device is a laser system for dermatological procedures, and the "performance" is described more qualitatively in terms of its intended clinical effects.

However, based on the nature of the submission, the implicit "acceptance criteria" for the FDA's 510(k) clearance are:

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies". However, it does not specify the sample size for these studies, nor does it explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "IDE Reliant studies" typically implies prospective clinical trials conducted under an Investigational Device Exemption (IDE), which are generally prospective. "Non-Significant Risk studies" would also typically involve prospective patient enrollment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical studies. Given this is a laser system and not an AI diagnostic tool, the "ground truth" would likely be clinical outcomes assessed by treating physicians/dermatologists, rather than interpretation by a panel of reviewers.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with AI assistance. This is expected as the device described is a laser system for treatment, not an AI diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "Laser System," not an "algorithm" or AI. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this medical device. The system is operated by a human.

7. The Type of Ground Truth Used

While not explicitly stated as "ground truth," for a therapeutic laser system, the "ground truth" of its efficacy would be based on clinical outcomes data from patients treated with the device. This would involve assessments of the reduction in wrinkles, improvement in scars, clearance of pigmented lesions, and overall skin resurfacing effects as observed and documented by clinicians, and potentially patient satisfaction. Safety would be assessed by tracking adverse events.

8. The Sample Size for the Training Set

The document refers to "Non-Significant Risk and IDE Reliant studies" for clinical analysis. For a physical device like a laser, this represents the clinical validation set, not a "training set" in the context of machine learning. The device itself (the laser system) is not an AI algorithm that "learns" from data in the way a diagnostic AI would. Therefore, the concept of a "training set sample size" as typically understood for AI/ML is not applicable.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" and "ground truth for the training set" in the AI/ML sense is not applicable to this device. Clinical studies would establish the safety and efficacy of the device based on observed patient outcomes.

Ask a specific question about this device

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;

Skin resurfacing procedures.

The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

The provided document is a 510(k) summary for the Fraxel II SR Laser System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a clinical study designed to meet them in the way a traditional clinical trial report would.

Therefore, the information requested in your prompt regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be fully extracted from the provided text. The document states that "Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement rather than a detailed report of a study meeting specific acceptance criteria.

However, I can provide what information is available and indicate what is not present.

Acceptance Criteria and Study for Fraxel II SR Laser System

Based on the provided 510(k) summary, the device's acceptance was predicated on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly the Fraxel SR Laser System (K050841). The primary "acceptance criteria" here is that the device performs "as clinically intended" and introduces "no new issues of safety and effectiveness" compared to the predicate.

The document does not detail specific quantitative acceptance criteria or a dedicated study with defined endpoints to "prove" the device meets these criteria in the way a pre-market approval (PMA) would require. Instead, it relies on the safety and performance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states: "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel SR Laser System."
• Sample Size: Not specified for any particular test set. The statement refers to "studies" in plural, implying prior data.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to as "Reliant studies," implying they were conducted by the manufacturer, Reliant Technologies, Inc., which is based in Mountain View, CA, USA.
• Retrospective or Prospective: Not specified.

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 510(k) summary. The summary does not describe a clinical study in detail that would involve establishing a ground truth with a specific number of experts or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not provided in the 510(k) summary.

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

• No. This document describes a laser system for dermatological procedures, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and was not performed.

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

• No. This is a hardware device (laser system) for direct treatment application by a medical professional, not an algorithm for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• This information is not explicitly provided. The "clinical analysis" mentioned likely relied on clinical endpoints and physician assessments related to the effectiveness of the laser in treating the indicated conditions (e.g., reduction in wrinkles, lightening of pigmented lesions, improvement in skin texture), which would fall under outcomes data and expert clinical assessment.

8. The sample size for the training set

• This is not applicable as this is not an AI/machine learning device that utilizes a "training set" in the computational sense. The "clinical analysis" referenced for performance would be based on prior trials/studies of the Fraxel SR Laser System and other related devices, but specific sample sizes for these prior studies are not detailed here.

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

• This is not applicable for the reasons stated in point 8.

Ask a specific question about this device