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1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Fraxel 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles).

Not Found

The document provided is an FDA 510(k) clearance letter for a medical device called the "Fraxel® FTX Laser System." It does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details typically associated with the evaluation of AI/ML-based medical devices or comparative effectiveness studies.

This document merely confirms that the FDA has reviewed the premarket notification for the Fraxel® FTX Laser System and determined it is substantially equivalent to legally marketed predicate devices for its stated indications for use (dermatological procedures involving soft tissue coagulation, skin resurfacing, treatment of various skin lesions, wrinkles, and scars).

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin.

CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems:

• 1. Console
• 2. Handpieces: 1440nm and 1927nm (Perméa) handpieces
• 3. Treatment Tip
• 4. Credit Key

The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin.

The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen.

The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero.

The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.

The provided document does not contain information about specific acceptance criteria, reported device performance, or a clinical study for the CLEAR+BRILLIANT TOUCH® Laser System as it would for an AI/ML powered device. This document is a 510(k) premarket notification for a medical device that utilizes laser technology for dermatological procedures, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

• Type of Device: The CLEAR+BRILLIANT TOUCH® Laser System is a physical laser device, not a software algorithm that performs diagnostics or prognostics. Therefore, the typical acceptance criteria and study designs (like standalone performance, MRMC studies, ground truth establishment) for AI/ML devices do not apply.
• 510(k) Clearance: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. The focus is on comparing technological characteristics, safety standards compliance, and non-clinical performance (like electrical safety, electromagnetic compatibility, biocompatibility, and software validation), rather than a clinical effectiveness study with specific diagnostic performance metrics like sensitivity or specificity.

However, I can extract the relevant information that is present in the document.

Information Present in the Document:

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

The document lists various non-clinical performance tests and standards to which the device must conform, and it states that the device "passed all the above applicable standards testing." These standards serve as the "acceptance criteria" for safety and basic performance.

The overall performance evaluation states: "The product performance testing demonstrates that the functional requirements have been met and that CLEAR+BRILLIANT TOUCH® Laser System is equivalent to the predicate device."

The following requested information is NOT applicable or NOT found in the provided document, as it pertains to AI/ML or clinical efficacy studies that are typically not part of a 510(k) submission for this type of laser device:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a laser device's non-clinical performance testing.
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 applicable. Ground truth for a laser device's safety and performance involves engineering and standards compliance, not medical expert interpretation of data.
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, as this is a laser device, not an AI/ML-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For this laser device, the "ground truth" for non-clinical testing is adherence to established engineering, electrical, biocompatibility, and safety standards.
8. The sample size for the training set: Not applicable (no AI/ML training set).
9. How the ground truth for the training set was established: Not applicable (no AI/ML training set).

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The VASERlipo System is intended for the fragmentation of subcutaneous fatty tissues for aesthetic body contouring.

The VentX console is intended for the suction of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERlipo System or as a stand-alone system.

The VASERlipo System is intended for the fragmentation, emulsification of subcutaneous fatty tissue for the purpose of aesthetic body contouring.

The VASERlipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues:

• · Neurosurgery
• · Gastrointestinal and affiliated organ surgery
• · Urological surgery
• · Plastic and reconstructive surgery
• · General surgery
• · Orthopedic surgery
• · Gynecological surgery
• · Thoracic surgery and
• · Laparoscopic surgery

The VASERlipo System is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.

The VASERlipo System is comprised of two components: the VASER Ultrasonic Amplifier and the VentX Infiltration and Aspiration Console. Both components are designed to operate independently, and may be sold or used separately/together, or as a system.

The Amplifier uses an ultrasonic surgical handpiece and probe to fragment and emulsify the soft tissue. The Console uses sterile tubing, a handle, and cannula to infiltrate the tissue with fluids and aspirate the fluids/soft tissue.

This document is a 510(k) premarket notification for the VASERlipo System, establishing its substantial equivalence to a predicate device. As such, it does not contain a typical "study" proving the device meets performance-based acceptance criteria for efficacy in the same way a new drug or novel medical device might. Instead, the "study" here is the non-clinical testing demonstrating compliance with electrical safety standards and functional specifications that show its substantial equivalence to the predicate.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by the predicate device's characteristics and relevant electrical safety standards. The "performance" is demonstrating that the new device meets these, primarily through non-clinical testing.

Important Note: The cannula dimensions (diameter and length) are presented in the document as slightly different between the subject and predicate devices. However, the document concludes "The technological characteristics of the VASERlipo System are substantially equivalent to those of the predicate device" and "shares the same indications for use, design features, and functional features". This implies these differences were deemed not to raise new questions of safety or effectiveness.

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

This document describes non-clinical testing of the device itself, not a clinical study involving human or animal subjects. Therefore, the concept of a "sample size for a test set" in the traditional sense of a clinical trial (e.g., number of patients) is not applicable. The provenance of the data is from internal laboratory testing conducted by Solta Medical Inc.

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

Not applicable. The "ground truth" for non-clinical device testing largely involves engineering specifications, electrical safety standards, and functional parameters. This is established through standard engineering and regulatory practices, not by expert consensus in a clinical context.

4. Adjudication Method for the Test Set:

Not applicable. This document pertains to non-clinical testing and substantial equivalence determination, not a clinical trial requiring adjudication of outcomes.

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. The VASERlipo System is a surgical device, not an AI/imaging diagnostic tool that would typically involve human readers or MRMC studies.

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

Not applicable. The VASERlipo System is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this 510(k) submission is primarily engineering specifications, functional parameters established by the predicate device, and compliance with recognized national and international electrical and medical device safety standards (e.g., IEC 60601-1, ISO 10079-1).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and cannula. The handpiece is connected to the controller and to an independent aspiration source. The controller sends electronic signals to the handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the handpiece.

The provided document is a 510(k) Pre-Market Notification for the PowerX Lipo System. It claims substantial equivalence to a predicate device, K110255, also named PowerX Lipo System.

This document describes a medical device (a suction lipoplasty system) rather than an AI/ML-driven diagnostic or prognostic device. Therefore, the typical acceptance criteria and study designs involving AI performance metrics (like sensitivity, specificity, AUC, human-in-the-loop studies, multi-reader multi-case studies, expert consensus for ground truth) as outlined in the prompt are not applicable to this submission.

The "acceptance criteria" for this device are based on its substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and safety and effectiveness profiles when tested against applicable non-clinical standards.

Here's how to interpret the provided information in the context of a 510(k) for a medical device:

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

The "acceptance criteria" here relate to the device meeting performance specifications and safety standards comparable to the predicate device. The document explicitly states:

And also lists compliance with electrical standards:

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

For this type of device, a "test set" in the AI/ML sense (e.g., a set of medical images) is not applicable. The testing here refers to engineering and bench testing to demonstrate compliance with performance and safety standards. The document does not specify sample sizes for these tests (e.g., how many cannulas were tested for deformation resistance), but often these are done on a representative sample to ensure manufacturing quality and design verification. Data provenance is not specified as it's not a clinical study on patient data.

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

Not applicable. "Ground truth" in this context is established by engineering specifications, international standards (IEC, ISO), and performance testing rather than expert medical interpretation of images.

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

Not applicable. This is not a study requiring adjudication of diagnostic findings.

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-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., IEC 60601-1, ISO 10079-1), and the performance characteristics of the predicate device. For example, a "ground truth" for suction vacuum might be a calibrated pressure gauge reading that matches the specified 20 inHg.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable.

In summary: The provided document is a standard 510(k) submission for a traditional medical device (suction lipoplasty system). The "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device through engineering and non-clinical performance testing against established safety and performance standards. The questions related to AI/ML software performance are not relevant to this specific device submission.

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The radiofrequency energy delivery components of the Thermage CPT System and Accessories are indicated for use in:

• · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• · Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
• · Non-invasive treatment of wrinkles and rhytids.

The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT System and Accessories are indicated for use in:

• · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• · Non-invasive treatment of periorbital wrinkles and rhytids:
• · Non-invasive treatment of wrinkles and rhytids;
• · Temporary improvement in the appearance of cellulite;
• Relief of minor muscle aches and pains;
• · Relief of muscle spasms;
• · Temporary improvement of local circulation (i.e., blood circulation).

The Thermage CPT System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage CPT System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs radio frequency tuning to provide radio frequency energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.

The provided text describes a Special 510(k) submission for the Thermage CPT System and Accessories, demonstrating its substantial equivalence to a predicate device. This submission focuses on modifications to an existing device rather than a new AI/ML device, so it doesn't contain all the information requested about AI model performance.

Here's what can be extracted and inferred from the document regarding acceptance criteria and testing:

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

The document lists "Summary of Testing" with "Requirement" as the acceptance criteria and "Results" as the reported performance.

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

The document states, "The treatment tip design shall be capable of delivering up to the maximum REP count, and shall be verified or validated to show with 90% confidence that the tips will do so with a minimum of 90% reliability." This implies that a sample of treatment tips was tested to determine their reliability in delivering REP counts. However, the exact sample size or the provenance of the data (e.g., how many tips were tested, if they were from a specific country, or if the testing was prospective) is not explicitly stated in this document. The testing appears to be centered on the physical and functional aspects of the device and its accessories, not clinical data from patients.

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 testing described appears to be engineering verification/validation, not human expert evaluation of clinical data.

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

Not applicable, as the testing described is not clinical adjudication.

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 device and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML device. The testing described is for the device's physical and functional integrity.

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

The "ground truth" for the tests described is based on engineering specifications and performance requirements (e.g., maximum REP count delivery, snap fit, fluid barrier, dielectric strength, burst pressure). It's essentially "meets design specifications."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. This is not an AI/ML device.

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The radiofrequency-energy only delivery components of the Thermage FLX System are indicated for use in:
· Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
· Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
· Non-invasive treatment of wrinkles and rhytids.

The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in:
· Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
· Non-invasive treatment of periorbital wrinkles and rhytids;
· Non-invasive treatment of wrinkles and rhytids;
· Temporary improvement in the appearance of cellulite;
· Relief of minor muscle aches and pains;
· Relief of muscle spasms;
· Temporary improvement of local circulation (i.e., blood circulation).

The Thermage FLX System is based on the technology and the performance of the existing Thermage CPT System and includes a similar RF (RF) Generator and Accessories.

The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage FLX System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.

The Thermage FLX System is comprised of three sub-systems: (1) the Console, (2) Handpiece and (3) Treatment Tip. Accessories used during each individual treatment included the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch.

The provided document, a 510(k) summary for the Thermage FLX System, describes the device, its intended use, and a comparison to predicate devices, but does not contain information about specific acceptance criteria, a clinical study proving the device meets those criteria, or the details typically associated with clinical trial reporting (sample size, data provenance, expert adjudication, MRMC studies, ground truth establishment, or training set details).

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with electrical and safety standards.

Therefore, the requested information based solely on the provided text is largely unavailable.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that the device passes various electrical and safety standards, but it doesn't present specific performance metrics or acceptance criteria for clinical effectiveness (e.g., wrinkle reduction percentage, cellulite improvement rate, etc.) that would typically be associated with an "acceptance criteria" table for device performance.

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

This information is not provided. The document details non-clinical tests (electrical safety, EMC, software, biocompatibility) but does not mention any clinical test set, subjects, or data provenance.

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

This information is not provided. As no clinical test set is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided.

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

This information is not provided. The document does not mention any MRMC studies or human reader improvement with or without AI assistance, as the device itself is not described as an AI or diagnostic tool requiring such studies. It's an energy-based therapeutic device.

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

This information is not provided. This question is not applicable as the device is not an algorithm acting in a standalone capacity; it's a physical medical device.

7. The Type of Ground Truth Used

This information is not provided as no clinical study or test set requiring ground truth is described. For the non-clinical tests, compliance with specified standards (e.g., IEC 60601-1) serves as the "ground truth" for safety and electrical performance.

8. The Sample Size for the Training Set

This information is not provided. The device is an energy-based system, not an AI or machine learning algorithm, so the concept of a "training set" in this context is not applicable.

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

This information is not provided, as there is no training set mentioned.

Summary based on the document:

The Thermage FLX System's "study" in this 510(k) context primarily refers to non-clinical testing to demonstrate compliance with relevant electrical, safety, and software standards, as well as functional, simulated use, environmental, and transport testing. The acceptance criteria for these tests are typically defined by the requirements of the standards themselves (e.g., passing specific electrical safety limits, meeting EMC requirements). The document asserts that the device passed all applicable standards testing, thereby demonstrating its safety and functional equivalence to predicate devices. It relies on a demonstration of substantial equivalence to previously cleared devices (Thermage ThermaCool CPT cleared under K090580 and K132431) rather than a de novo clinical trial with specific clinical performance acceptance criteria.

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The radiofrequency-energy only delivery components of the Thermage CPT® System and Accessories are indicated for use in:

• Dermatologic and General Surgical procedures for electrocoagulation and hemostasis:
• Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
• Non-invasive treatment of wrinkles and rhytids.
  The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT® System and Accessories in indicated for use in:
• Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;
• Non-invasive treatment of periorbital wrinkles and rhytids;
• Non-invasive treatment of wrinkles and rhytids;
• Temporary improvement in the appearance of cellulite;
• Relief of minor muscle aches and pains;
• Relief of muscle spasms;
• Temporary improvement of local circulation (i.e., blood circulation).

The Thermage CPT System delivers monopolar radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis. Cleared for commercial distribution under K090580, the Thermage CPT System delivers a maximum power of 500W of energy from the disposable tip to the patient. The Handpiece delivers output energy and cooling while also offering user-selectable vibration in the vertical dimension for mechanical manipulation of tissue. Vibration is active only during each treatment cycle while the 3cm² treatment tip is in contact with the skin. Vibration is not active when either the activation switch is released, when the treatment tip is not in contact with the skin, or when the 0.25cm2 eye tip is used. Single-use, disposable Treatment Tips are attached to the Handpiece that comes in contact with the patient during the treatment procedure. The Treatment Tip is classified as a direct skin contact device of limited duration (

This 510(k) summary describes a modification to an existing device, the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to "clean" and non-sterile for single patient use. It is not a study to prove acceptance criteria for a new device's performance, but rather a demonstration of substantial equivalence for a modified existing device.

Therefore, many of the requested categories for a new device's study and acceptance criteria (e.g., specific performance metrics, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable in this context.

Here's an adaptation of your requested format based on the provided 510(k) summary:

Thermage CPT® System (TG-2B) Modification Acceptance Criteria and Justification of Equivalence

The document describes a modification to the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to non-sterile ("clean") for single patient use. The acceptance criteria for this modification revolve around demonstrating that this change does not introduce new risks and that the modified device remains substantially equivalent to the cleared predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

1. Risk documents review: FMEA's and Hazard Analysis conducted.
2. Complaints incidence and review: No issues identified related to this change.
3. Manufacturing environment and process evaluation, including bioburden monitoring trends: This evaluation confirmed the suitability of the "clean" non-sterile state for single-patient use.
4. Design Control Conformance: Declared conformance to design controls (21 CFR 820).
5. Elimination of Cross-Contamination Risk: The "single patient use" and disposable nature of the tips eliminates the risk of cross-contamination between patients, rendering the non-sterile condition inconsequential in this aspect. |
   | Performance/Effectiveness: Maintain substantial equivalence in intended use and technological characteristics to the predicate device. | Demonstrated by:
6. Comparative Table Analysis: The provided tables show that all key technological characteristics (e.g., energy type, frequency, max RF power, treatment type, handpiece and electrode features, and indications for use) of the modified device are identical or substantially similar to the predicate Thermage CPT System and other predicate devices.
7. Indications for Use: The indications for use for the modified device are identical to those of the predicate Thermage CPT System. The only difference in "Treatment Tip Condition" (non-sterile vs. sterile) and "Condition of Use" (Disposable Single Patient Use Only vs. Reusable Multiple Patient Use* for some predicates) is explicitly addressed by the single-use nature of the modified tips. |

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

This was not a clinical study with a "test set" as would be typically understood for evaluating device performance metrics. Rather, it was a regulatory submission demonstrating substantial equivalence for a manufacturing change.

• Sample Size: Not applicable in the context of a "test set" for performance evaluation. The "data" considered included risk assessments, manufacturing evaluations, and historical complaint data for the predicate device.
• Data Provenance: The data provenance is internal to Solta Medical, Inc., consisting of various internal analyses related to design control, manufacturing processes, and risk management. It is retrospective in the sense of reviewing existing safety and manufacturing data. Country of origin is the USA (manufacturer is Solta Medical, Inc., in Hayward, CA).

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

Not applicable. This submission focused on regulatory compliance and risk management for a product modification, not on establishing a "ground truth" for a performance study dataset. The "experts" would be the internal regulatory, quality, and engineering teams at Solta Medical, Inc. responsible for design controls and risk assessments.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or adjudication method was used for performance measurement. The evaluation was a regulatory assessment based on documented evidence.

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

No. An MRMC study is typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance. This device is an electrosurgical unit used for aesthetic and surgical procedures, and the submission concerns a change in tip sterility, making an MRMC study irrelevant.

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

No. This device is a treatment system that requires human operation. It does not involve an "algorithm only" component in the sense of artificial intelligence. The submission focuses on the safety and equivalence of a physical component modification.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the existing predicate Thermage CPT System (K090580) and the demonstration that the modification does not alter this "ground truth" or introduce new unacceptable risks. This is based on regulatory standards, risk management principles, and product performance history.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm for this type of device modification submission.

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

Not applicable, as no training set was used.

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1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Fraxel 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

The Fraxel DUAL 1550/1927 nm Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. 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 text is a 510(k) summary for the Fraxel DUAL 1550/1927 nm Laser System. It focuses on demonstrating substantial equivalence to predicate devices for expanded indications of the 1927 nm laser.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific metrics (e.g., success rates, percentage improvement). Instead, the acceptance criterion for regulatory clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices and that expanded indications do not raise new issues of safety and effectiveness.

Study Description:

A "clinical study" was conducted. The primary goal of this study was to:

• Confirm that the Fraxel DUAL 1550/1927 nm Laser System performs as intended.
• Demonstrate that the expanded indications for the 1927 nm laser do not introduce new safety and effectiveness concerns compared to the predicate device.

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

• Sample Size: The document states that "A clinical study was conducted" but does not specify the sample size for this study.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information regarding:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's performance against a predicate, not how human readers' performance improves with or without the device.

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

This device is a physical laser system for dermatological procedures, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.

7. The Type of Ground Truth Used

The document implies that "clinical performance data" was collected to confirm the device performs as intended and to assess safety and effectiveness for the expanded indications. However, it does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). In the context of a laser treatment for skin conditions, this would likely involve clinical assessments by dermatologists, possibly photographic documentation, and patient-reported outcomes, but the document does not elaborate.

8. The Sample Size for the Training Set

This device is a physical laser system, not an AI or machine learning algorithm that requires a "training set." Therefore, the concept of a training set does not apply.

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

As stated above, the concept of a training set does not apply to this device.

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Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

The Isolaz® 2 System delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via a delivery handpiece utilizing photopneumatic technology. The system consists of a main console and a treatment handpiece. The desired power and delivery time are set by the operator. The modifications made to the device were to reduce and simplify device settings.

The provided text describes a 510(k) summary for the Isolaz® 2 Intense Pulsed Light System, which is a medical device intended for the treatment of mild to moderate acne. However, the text does not contain specific acceptance criteria or a detailed study plan with performance data in the way you've outlined in your request.

Medical device 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device. This often means showing that the new device has similar technological characteristics and is as safe and effective as a legally marketed device, rather than presenting a novel study against predefined quantitative performance criteria.

Therefore, many of the requested data points (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not available in the provided document.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative metrics. The overall acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device in terms of safety and effectiveness.
• Reported Device Performance: The document states:
  • "Verification and validation data show that the device meets all product specifications."
  • "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
  • No specific clinical outcome percentages (e.g., X% reduction in acne lesions) are provided in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies mentioned ("Laboratory and performance tests") were likely internal engineering and safety tests rather than patient-based clinical trials for performance efficacy in the way a pharmaceutical trial might be.

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

• Not applicable/Not specified. The summary focuses on engineering and safety compliance rather than clinical validation against expert judgment of acne condition.

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

• Not applicable/Not specified.

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 MRMC study was mentioned. This device is not an AI diagnostic tool that requires human interpretation.

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

• Not applicable. This is a light-based therapy device, not a diagnostic algorithm. Performance would relate to its physical output and biological effect, not an algorithmic output requiring standalone evaluation.

7. The type of ground truth used:

• Not applicable in the conventional sense of diagnostic device ground truth. The "ground truth" for this device would be its ability to consistently produce the specified light parameters and its safety in use, rather than a clinical outcome measured against an external standard like pathology. The summary mentions compliance with safety standards (IEC 60601-1, 60601-1-4, 60601-1-2) and biocompatibility (ISO 10993-1).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning algorithms that require a "training set."

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

• Not applicable.

Summary of Device Rationale from the Document:

The Isolaz® 2 Intense Pulsed Light System is seeking 510(k) clearance by demonstrating substantial equivalence to its predicate device, the Isolaz® Intense Pulsed Light System (K083730).

Key claims for substantial equivalence:

• Similar Design and Technology: Delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via photopneumatic technology, similar to the predicate.
• Similar Intended Use: Treatment of mild to moderate acne (pustular, comedonal, inflammatory) in all skin types (Fitzpatrick I-VI), identical to the predicate.
• Similar Technological Characteristics: Similar in design specification, output energy, and delivery system.
• Minor Modifications: Modifications to the system console and handpiece hardware and circuitry do "not significantly affect the safety or effectiveness of the device."
• Compliance with Standards: Evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, and ISO 10993-1 for biocompatibility of treatment tips.
• Performance Data (General Statement): "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

In essence, the "acceptance criteria" here are that the new Isolaz 2 system has not introduced new safety or effectiveness concerns compared to its predicate and that its modifications are minor, as demonstrated by engineering and safety testing, which allows it to leverage the predicate's established safety and efficacy profile.

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The Clear + Brilliant Laser System is intended for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The Clear + Brilliant™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The Clear + Brilliant Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece. The original Clear + Brilliant Laser System has a single hand piece containing a 1440 nm diode laser. A second hand piece with a 1927 nm diode laser has been added to the system as a line extension which provides an additional laser wavelength option at the same low power settings of the predicate Clear + Brilliant Laser System.

The provided text describes a 510(k) summary for the Clear + Brilliant™ Laser System, which is a non-ablative laser system for dermatological procedures. This document aims to establish substantial equivalence to a predicate device.

However, the information provided does not contain details about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other similar quantitative measures for an AI/algorithm-driven device.

Instead, the document focuses on:

• Safety and Effectiveness criteria by demonstrating compliance with electrical safety, EMI/EMC, laser safety, and biocompatibility standards.
• Substantial equivalence to a predicate device based on design specification, output energy, delivery system, and intended use.
• Verification and validation data showing the device meets "all product specifications" and functions "as intended."

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance studies (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance) as this information is not present in the provided text. The device described is a physical laser system, not an AI/algorithm-driven diagnostic or prognostic device that would typically have the performance metrics you've asked for.

The relevant section "7. Performance Data" states: "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." This is a general statement and does not provide specific quantitative acceptance criteria or detailed study results for metrics like those typically associated with AI performance.

Without further information that explicitly details acceptance criteria for an AI/algorithm's performance and a study proving it, I cannot fulfill the request as specified.

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