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The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:

-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.

The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:

• Actinic and seborrheic keratoses;
  -Chelitis;
  -Cutaneous horns;
  -Hemangiomas;
  -Keloids;
  -Nevi, including spider, epidermal and protruding;
  -Rhinophyma;
  -Syringomas;
  -Warts;
  -Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.

The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.

The provided text is a 510(k) summary for the Fraxel re:pair (Fraxel III SR) Laser System and Accessories. It focuses on establishing substantial equivalence to previously marketed devices (K063038, K071051, K022060, K030147) rather than presenting a study with specific acceptance criteria and detailed performance metrics for this particular device.

Therefore, the information required to populate the tables and answer the questions regarding acceptance criteria and a study proving the device meets those criteria is largely not present in the provided document. The document describes clinical performance data from "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece," but it does not provide details of these studies, such as specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

It states: "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This indicates that the device's clearance is based on its similarity to existing cleared devices, not on a new, independent study with defined acceptance criteria for this specific iteration.

However, I will extract any relevant information that might vaguely touch upon the requested points, even if it doesn't fully fulfill the criteria.

Acceptance Criteria and Reported Device Performance

As noted, the document does not define specific, quantifiable acceptance criteria or provide a table of performance metrics for this new device's clinical performance. The substantial equivalence argument relies on the predicate devices having "equivalent performance specifications."

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document. The document mentions "Non-Significant Risk and Investigational Device Exemption studies," suggesting prospective clinical studies, but no details are given.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified in the provided document.

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

   • Not specified in the provided document.

4. 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/Not mentioned. This is a medical device (laser system) for dermatological procedures, not an AI-assisted diagnostic device typically subject to MRMC studies comparing human reader performance.

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

   • Not applicable/Not mentioned. This is a laser system, not an AI algorithm. Its performance is inherent to the device's physical operation.

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

   • Not specified in the provided document. For clinical studies supporting laser systems, ground truth often involves clinical assessments, photographic documentation, and patient-reported outcomes related to the treated conditions (wrinkles, lesions, etc.).

7. The sample size for the training set

   • Not applicable/Not mentioned. This is a hardware medical device, not an AI model that requires a training set in the conventional sense.

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

   • Not applicable/Not mentioned.

Summary of what is available in the document regarding studies:

The document briefly states: "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece." This confirms that clinical studies were performed, but the 510(k) summary itself does not provide the detailed study results, acceptance criteria, methodologies, or sample sizes of these studies. The substantial equivalence argument relies on the existence of these studies for the predicate device, or implicitly, for this device's performance being similar to the predicates.

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

Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.

Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.

This 510(k) summary describes a Fraxel III SR Laser System (Fraxel re:pair™) for dermatological procedures. It doesn't contain information about a study with acceptance criteria and a reported device performance table as would be typical for an AI/ML device submission. Instead, it relies on substantial equivalence to predicate devices and clinical data from non-significant risk and investigational device exemption studies to support its safety and effectiveness.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. This submission is for a medical device (laser system), not an AI/ML diagnostic or predictive tool, and thus the structure of its performance evaluation is different. Performance is asserted based on clinical intent and no new safety/effectiveness issues, rather than statistical metrics against specific acceptance criteria.

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

This information is not explicitly provided. The document states:
"Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System."
"Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories."

Without access to the actual study reports, details on sample sizes, patient demographics, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodologies for these underlying clinical studies are unavailable in this 510(k) summary.

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

This information is not provided. The assessment relies on the overall clinical performance demonstrated in the aforementioned studies, but the role of experts for "ground truth" as you'd define it for an AI model is not detailed here. The clinical evaluation implicitly involves medical professionals, but their specific role in establishing "ground truth" for a test set is not described.

4. Adjudication Method for the Test Set

This information is not provided. As this is not an AI/ML submission where a ground truth is established for a test set through human review, an adjudication method for such a test set is not detailed.

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

A MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for AI/ML diagnostic tools where the impact of AI assistance on human readers is being evaluated. This submission is for a therapeutic laser device.

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

A standalone performance study is not applicable and therefore not mentioned. This device is a laser system; its "performance" is inherently tied to its application by a trained medical professional. It does not operate as an algorithm independently.

7. The Type of Ground Truth Used

The concept of "ground truth" as applied to AI/ML models is not directly applicable or discussed in this document. The "ground truth" for a therapeutic device's effectiveness would be clinical outcomes observed in patients (e.g., reduction in wrinkles, successful soft tissue ablation), as determined by medical professionals in the clinical studies. The summary states that "The device performed as clinically intended with no new issues of safety and effectiveness introduced."

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" in the context of machine learning is not relevant to this submission, which is for a hardware device (laser system). The "training" here would refer to the engineering and development of the laser itself and clinical trials involving patients.

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

This information is not provided. Again, the concept of "ground truth for a training set" as used for AI/ML models is not directly applicable to a therapeutic laser device. The "ground truth" in device development relates to engineering specifications and clinical efficacy/safety observed in product development and clinical trials.

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Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.

The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube. The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller

The provided document is a 510(k) summary for the Reliant Technologies C300 Chiller System. It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format typically used for medical AI device submissions.

This document describes a physical medical device (a chiller system) rather than an AI/ML-driven diagnostic or prognostic device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training) are not applicable to the information presented in this 510(k) summary.

The closest information related to "acceptance criteria" and "device performance" in the context of this document is the claim of "Clinical Performance Data" and "Technological Characteristics" for establishing substantial equivalence.

Here's an attempt to answer the request based only on the provided text, acknowledging that much of the requested information for AI/ML devices is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is a physical device, and the evaluation for substantial equivalence does not involve a "test set" in the context of AI/ML performance evaluation studies. The document mentions "Sufficient safety data has been gathered," but does not specify the sample size or provenance of that data beyond it being part of the clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe an AI/ML device requiring ground truth establishment by experts for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI/ML diagnostic or prognostic device designed 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 chiller system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be engineering specifications (e.g., actual cooling capacity vs. designed cooling capacity) and clinical safety outcomes. The document broadly refers to "sufficient safety data" and "performs as clinically intended," but doesn't detail how this "ground truth" was established or measured.

8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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The Fraxel® SR 1500 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 for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures.

The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

The provided 510(k) summary for the Fraxel® SR1500 Laser System and Accessories does not contain information about acceptance criteria or a study proving its performance against such criteria in the manner typically expected for diagnostic AI/ML devices.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices based on identical or similar indications for use and technological characteristics. This type of submission relies on the prior clearance of the predicate devices and argues that the new device does not introduce new issues of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or not provided in this specific 510(k) document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text:

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

• Not Provided. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., sensitivity, specificity, accuracy, dice score, etc.) for the device. The "performance" mentioned refers to the device performing as clinically intended, which is a qualitative statement based on comparison to predicate devices, not specific metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Provided. This type of information is typically found in clinical studies, which are not detailed in this 510(k) summary for establishing performance against criteria. The "clinical performance data" mentioned is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Provided. Since no specific test set or ground truth establishment process is described, information about experts is absent.

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

• Not Provided. As no test set is detailed, no adjudication method is mentioned.

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 / Not Provided. The Fraxel® SR1500 Laser System is a physical laser device for dermatological procedures, not an AI/ML diagnostic or image interpretation tool designed to assist human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

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

• Not Applicable / Not Provided. This device is a laser system, not a standalone algorithm.

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

• Not Provided. No ground truth is described as the 510(k) focuses on substantial equivalence to predicate devices, not novel performance claims requiring new clinical validation data.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is a laser system, generally not trained in the same way an AI/ML algorithm would be. The device itself is "controlled by an embedded processor" but the submission doesn't describe any machine learning training.

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

• Not Applicable / Not Provided. See point 8.

Summary based on the Provided Text:

The 510(k) submission for the Fraxel® SR1500 Laser System and Accessories does not describe specific acceptance criteria or an analytical/clinical study to demonstrate performance against such criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Fraxel® II SR Laser Systems, Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) based on:

• Identical or similar indications for use.
• Identical key technological characteristics (energy type, operating principle) to at least one of its predicates (K062303).

The statement "The clinical performance data reviewed supported the determination that the Fraxel® SR1500 Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced" indicates that existing clinical data from the predicate devices, or potentially other general clinical understanding of fractional ablative lasers, was sufficient to support the substantial equivalence claim without requiring new, specific performance studies with defined acceptance criteria for this device itself.

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

Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.

The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.

The provided text describes the 510(k) summary for the Fraxel III SR Laser System. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a detailed study.

The document states:

• "Clinical analysis was conducted on Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel III SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel III Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced."

This indicates that clinical studies were performed, and favorable safety data was collected, but the specific metrics, acceptance criteria, sample sizes, expert details, or study methodology (e.g., MRMC, standalone) are not provided in this summary.

Therefore, I cannot fill out the detailed tables and information sections you requested based solely on the provided text. The document focuses on regulatory approval based on "substantial equivalence" to predicate devices rather than a detailed report of a specific clinical trial's performance metrics against predefined acceptance criteria.

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The Fraxel IV 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 IV SR Laser System consists of a fiber laser, 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 skin.

The provided text for K063808 is a 510(k) summary of safety and effectiveness for a medical device (Fraxel IV SR Laser System and Accessories). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, novel acceptance criteria through a dedicated study.

Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and a study proving the device meets them.

Here's why and what information is contained:

• No Acceptance Criteria or Device Performance Table: The document does not define specific performance metrics or acceptance criteria for the Fraxel IV SR Laser System. Instead, it relies on demonstrating that its indications for use and technological characteristics are substantially equivalent to already approved predicate devices.
• No Dedicated Study to Prove Criteria: Because no new, specific acceptance criteria are presented for this device, there is no study described that aims to prove the device meets such criteria. The "Clinical Performance Data" section merely states, "Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement, not a detailed study report.
• No Information on Sample Sizes, Data Provenance, Expert Ground Truth, or Adjudication: Since there isn't a detailed study described for this device, there is no information about sample sizes for test sets, data provenance, the number or qualifications of experts, or adjudication methods.
• No MRMC or Standalone Study Information: The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies. The Fraxel IV SR is a physical laser system, not an AI or imaging diagnostic tool.
• No Ground Truth Type or Training Set Information: As there's no diagnostic or analytical algorithm being evaluated, the concepts of ground truth (expert consensus, pathology, outcomes data) and training sets are not applicable or discussed in this context.

In summary, the provided 510(k) pertains to demonstrating substantial equivalence, not to presenting a study proving a device meets specific quantitative acceptance criteria.

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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.

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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.

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

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of surgical scars and acne 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 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 upper dermis. Device accessories include tip attachments.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular criteria in terms of numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

However, based on the Clinical Performance Data section, we can infer the overarching acceptance criteria and the nature of the study:

Inferred Acceptance Criteria:

The primary acceptance criteria were that the Fraxel SR Laser System:

• Functioned as clinically intended.
• Performed as clinically intended.
• Introduced no new issues of safety and effectiveness compared to predicate devices.

Study that Proves the Device Meets Acceptance Criteria:

A "clinical investigation" was conducted.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The text only mentions "Clinical performance data was used" and "The results from clinical investigation."
• Data Provenance: Not explicitly stated. It is a "clinical investigation," which typically implies prospective data from human subjects. However, the country of origin is not mentioned.

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 type of "clinical investigation" and how effectiveness was judged (e.g., by experts) is not detailed.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a "Dermatology Laser" system, not an AI software intended for interpretation by human readers. Therefore, an MRMC study and effect size for human reader improvement with AI assistance are not relevant to this device's evaluation.

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

This is not applicable. The Fraxel SR Laser System is a physical laser device used by a clinician, not a standalone algorithm.

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

The document mentions "clinical investigation" and demonstrating that the system "functioned as clinically intended" and "performs as clinically intended." This strongly suggests that clinical outcomes data (e.g., observed changes in skin, reduction in wrinkles/scars, efficacy in pigmented lesion treatment) were used. Pathology might be relevant for some indications but is not explicitly stated as the ground truth method.

8. The sample size for the training set:

The document describes a "clinical investigation" for performance data. It does not mention a "training set" in the context of machine learning, as this is a physical device, not an AI algorithm. Therefore, "training set" information is not applicable.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable to this device description.

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The Reliant Laser System II is intended for use in:

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), melasma and dyschromia;

Skin resurfacing procedures.

The Fraxel 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 upper dermis. Device accessories include tip attachments.

This submission for the Fraxel SR Laser System (K050841) does not contain a specific study proving the device meets individual acceptance criteria in the format typically seen for AI-enabled devices or diagnostics. Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices.

Here's an breakdown based on the provided text, addressing the points you requested where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not list specific numerical acceptance criteria (e.g., minimum sensitivity, maximum false positive rate) or present a table of device performance against such metrics. The core argument for acceptance is based on substantial equivalence.

• Coagulation of soft tissue | "Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended" |
  | - Treatment of periorbital wrinkles | |
  | - Photocoagulation of pigmented lesions | |
  | - Skin resurfacing procedures | |

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

The submission mentions "clinical investigations" and "clinical studies" but does not specify the sample size for any test set. It states: "Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended."

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "peer-reviewed publications and clinical investigations," which suggests a mix of existing literature and possibly some internal studies, but details are absent.

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

This information is not provided in the document. The submission references "clinical studies" but does not detail the methodology for establishing ground truth within those studies or the role/qualifications of experts involved. Given the nature of a laser system for dermatological procedures, the "ground truth" would likely be clinical outcomes observed by dermatologists, but the specifics are not elaborated upon.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1). This level of detail regarding study design and independent review of results is not present in this 510(k) summary.

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

No, an MRMC comparative effectiveness study, especially one involving AI assistance, was not mentioned or relevant to this 2005 submission for a laser device. The Fraxel SR Laser System is a physical device, not an AI or diagnostic tool that assists human readers.

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

Not applicable. As stated above, this is a physical laser device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document implies the ground truth for device performance is based on clinical outcomes data from "clinical studies" and "peer-reviewed publications." For dermatological procedures like those listed, this would likely involve clinical assessments of improvements in skin conditions, reduction of wrinkles, or removal of lesions. However, the specific methodology for establishing this ground truth (e.g., scoring systems, objective measurements) is not detailed.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are typically associated with machine learning or AI models. This submission is for a medical device (laser system), not an AI algorithm.

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

Not applicable. As the concept of a training set does not apply, neither does the method for establishing its ground truth.

Summary of Approach for this Device (K050841):

The regulatory strategy for the Fraxel SR Laser System in this 510(k) relied heavily on demonstrating substantial equivalence to existing predicate devices (Fraxel SR Laser System K043219, Palomar Starlux K033549, Sciton BBL System K032460). The manufacturer argued that:

• The technological characteristics and indications for use were similar.
• Differences did not raise new safety or effectiveness issues.
• The device complied with regulatory standards for laser products (21 CFR 1040).
• "Sufficient data" from clinical studies and peer-reviewed publications supported that the device functioned as intended and was safe and effective.

This approach is common for medical devices where a direct comparison to similar, already-approved devices can be made, rather than requiring extensive de novo clinical trials with detailed performance metrics against a rigorously established ground truth, as might be expected for novel diagnostic devices or AI solutions.

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