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The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.

The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.

The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.

The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

The provided text is a 510(k) clearance letter and summary for the AVAVA™ Skin Treatment System, a laser device. It does not describe an AI/ML device or a study proving its performance against specific acceptance criteria for such a device.

The study described is a clinical study for the device's efficacy and safety in treating acne scars. It involves human subjects, photographs, and expert evaluators, but it is not an AI/ML performance study where an algorithm's output is being evaluated against ground truth.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the provided document does not contain this information.

To illustrate, if this were an AI/ML device performance study, the sections would be filled using information that is NOT present in the provided document:

Hypothetical Section (based on the prompt's requirements, NOT the provided text):

Hypothetical AI/ML Device Performance Study Description (Illustrative, NOT from provided text)

This section outlines what would be expected for an AI/ML device performance study, but the information is not available in the provided 510(k) summary for the AVAVA™ Skin Treatment System.

1. Acceptance Criteria Table and Reported Device Performance

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The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.

The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.

The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

This FDA 510(k) summary does not contain the detailed information necessary to answer all aspects of your question regarding acceptance criteria, study details, and specific performance metrics. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical trial report.

Here's what can be extracted and what information is missing:

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

The document mentions "performance testing results" and that "the data show that the MIRIA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate device." However, specific numerical acceptance criteria or performance metrics are not provided.

The performance testing listed is:

• Software verification and validation
• Electrical Safety testing (per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012)
• EMC Testing (per IEC 60601-1-2: 2014-02)
• Histology study and computational simulations to evaluate lesion geometry
• Sample clinical data to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.

Without the specific criteria for "lesion geometry" or "safety" from these studies, a table cannot be fully constructed.

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

The document states: "Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety."

• Sample size: Not specified. It only says "Sample clinical data."
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

This information is not provided. The document mentions a "Histology study" and "computational simulations" to evaluate lesion geometry, and "sample clinical data" for safety and CTZ shape. It does not elaborate on how ground truth was established for these or who was involved.

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

This information is not provided.

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 as the device is a laser skin treatment system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This is not applicable in the context of typical AI algorithm evaluation. The device is a physical laser system. While it is "software-controlled," the performance testing described relates to the physical and electrical safety and the biological effect of the laser, not a diagnostic algorithm.

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

Based on the performance testing mentioned:

• Histology study and computational simulations: This suggests histology (pathology) would be a key ground truth for "lesion geometry." Computational simulations provide a model, not empirical ground truth.
• Sample clinical data: This would typically rely on clinical observations/assessments for safety and the confirmation of CTZ shape.

8. The sample size for the training set

This is not provided. If there was any machine learning involved in the device's control software to optimize treatment parameters, the document does not elaborate on it or any specifics about training data. Given the device type, "training set" in the context of typical AI/ML is likely not directly applicable here.

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

This is not provided, and again, may not be applicable in the traditional AI/ML sense for this type of device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technical specifications, safety standards compliance, and general performance statements rather than detailed clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies, especially those relevant to AI device evaluations.

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The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.

The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

The provided text describes the MIRIA Skin Treatment System and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document outlines performance testing conducted to verify certain aspects of the device, particularly regarding its expanded pulse energy range compared to the predicate.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

The document mentions several verification methods and implies that the device performs in accordance with its specifications and requirements. However, it does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric, nor does it present the reported device performance in a comparative table against those criteria.

Information from the document (Implied Performance):

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

• Sample Size: The document does not specify the sample size for any of the performance tests (e.g., healing study, energy delivery verification).
• Data Provenance: The document does not provide information on the country of origin of the data, nor does it state whether the studies were retrospective or prospective.

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)

The document does not mention the use of experts to establish ground truth for any of the tests, nor does it specify their number or qualifications. The healing study implies some form of assessment, but details are absent.

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

No information regarding adjudication methods for the test set is provided.

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

The MIRIA Skin Treatment System is a laser device for dermatologic procedures; it is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving "human readers" or "AI assistance" would not be applicable to this type of medical device as described in this document.

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

This question is not applicable. The MIRIA Skin Treatment System is a physical device with software control, not an algorithm being tested for standalone performance in a diagnostic context. The document confirms it is a "software-controlled device" and that "software verification and validation" were performed.

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

The document implicitly refers to "healing post-treatment" as an outcome, and the "creation of conical microscopic treatment zones (CTZs)" as verifiable physical effects. However, it does not explicitly state the method used to establish the ground truth for these observations (e.g., whether CTZs were confirmed by histology/pathology or expert visual assessment).

8. The sample size for the training set

The document describes performance testing and verification, not a machine learning model that would require a separate "training set." Therefore, this information is not applicable in the context of this submission. Software verification and validation refer to testing the software's functionality and adherence to specifications, not training a predictive model.

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

As there is no mention of a machine learning training set, this question is not applicable.

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The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi..

The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions.

The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly.

The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.

The provided regulatory document (K213726) for the PL-1 Skin Treatment System focuses on demonstrating substantial equivalence to a predicate device (Quanta Chrome, K202503) rather than presenting a clinical study where the device performance is measured against specific acceptance criteria.

The document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device with ground truth establishment, expert adjudication, or MRMC studies.

Instead, it asserts substantial equivalence based on:

• Same intended use and similar indications for use.
• Similar technological characteristics and operating principles (e.g., laser type, wavelength, mechanism of action, focused microbeams).
• Performance testing for safety and basic functionality compliant with established standards, such as electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software life cycle processes (IEC 62304), usability (IEC 60601-1-6, IEC 62366-1), and laser specific safety (IEC 60601-2-22, IEC 60825-1).
• Biocompatibility (ISO 10993-1).

The document explicitly states: "Animal studies and clinical performance testing were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate device." This indicates that a study with the characteristics typically seen for AI/algorithm-driven medical devices (like those requiring test sets, expert ground truth, MRMC studies) was not conducted for this 510(k) submission.

Therefore, I cannot provide a table of acceptance criteria and proven device performance, nor can I answer points 2 through 9, as this information is not present in the provided text. The submission relied on demonstrating technological equivalence and compliance with relevant safety and performance standards for a laser device, not on clinical performance metrics with a test set and associated ground truth.

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The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The SR-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.

The SR-1 Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the optics, scanner, laser aperture, and contact cooling interface.

The SR-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.

The provided text describes the 510(k) summary for the SR-1 Skin Treatment System, comparing it to predicate devices. However, it does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics in a table, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance).

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and safety and efficacy studies rather than outlining specific performance metrics for acceptance.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is missing:

Acceptance Criteria and Study for SR-1 Skin Treatment System

The provided 510(k) summary does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in the format requested. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, which involves:

1. Technological Characteristics Comparison: Showing the SR-1 has similar operating principles, laser source, output power, etc., to predicate devices.
2. Safety and Performance Testing: Compliance with international standards for electrical safety, EMC, usability, biocompatibility, and laser safety.
3. In-vivo Human Study: A histological assessment comparing the thermal damage zones and healing rates to a predicate.

Therefore, a table of "acceptance criteria" as performance metrics isn't explicitly provided, as the criteria for clearance are primarily based on substantial equivalence and safety/functionality compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for clinical performance (e.g., a specific percentage of improvement in skin resurfacing) are not detailed in this document, such a table cannot be constructed from the provided text. The document states that the histological data "show that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements," implying that its performance (specifically in terms of thermal damage zones and healing rate) was found comparable to the predicate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for In Vivo Study: 14 healthy subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be a prospective in vivo human study based on the description "A 14 day in vivo human study assessing safety, healing and MTZ morphology was performed..."

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, other than "histological analysis" was performed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done?: No. The device is a laser treatment system, not an imaging interpretation device where human reader performance would be compared with and without AI assistance. The study described is an in vivo histological assessment.
• Effect size of human readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done?: Not directly applicable in the terms of an "algorithm only" performance for diagnosis. The device is a physical laser treatment system with software control. Software verification and validation were performed according to IEC 62304 and FDA guidance, indicating that the software's functionality was tested.

7. Type of Ground Truth Used

• Ground Truth Type: "Histological analysis" was used to determine the zones of thermal damage and healing rate in the in vivo human study.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a laser treatment system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or diagnosis). Its software underwent "verification and validation testing."

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model being trained for diagnostic or predictive tasks. The software "ground truth" (i.e., its correct functionality) would be established through software requirements, design specifications, and subsequent verification and validation testing.

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