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Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.

Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.

The provided text describes the Avéli device, which is indicated for long-term reduction in the appearance of cellulite and for soft tissue dissection. The 510(k) submission (K232153) is to expand the indications of use to include soft tissue dissection during general and plastic surgical procedures.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the expanded indication of "soft tissue dissection during general and plastic surgical procedures" in the same format as a table with reported device performance against specific numerical targets.

Instead, it lists types of verification testing conducted to support the substantial equivalence determination for this expanded indication. The conclusion states that "Performance test data demonstrates sufficient performance for soft tissue dissection." This implies that the device met internal design specifications and performance requirements for the soft tissue dissection function.

Here's a summary of the types of performance testing that serve as the basis for demonstrating compliance for the soft tissue dissection indication:

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

The document does not specify the sample sizes used for the various non-clinical verification tests (e.g., number of devices tested for functional, mechanical, or electrical tests). It only lists the types of tests performed.

The document also does not provide any information about the provenance of data (e.g., country of origin, retrospective or prospective) for these non-clinical tests. These are typically internal lab tests conducted by the manufacturer.

For the initial indication of "long-term reduction in the appearance of cellulite in the buttocks and thigh areas," the text states it is "supported by clinical data demonstrating treatment benefits through one year of observation." However, details on this clinical data (sample size, provenance, study design) are not provided within this document specifically for the cellulite indication. This submission focuses on the expanded indication for soft tissue dissection which is supported by non-clinical testing for substantial equivalence to a predicate device.

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 tests described are non-clinical verification tests, which typically involve laboratory measurements and assessments against engineering specifications, rather than expert-derived ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests listed are non-clinical engineering and performance tests, an "adjudication method" in the sense of resolving disagreements among expert reviewers of test data is not typically applicable or described in this type of summary.

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

No MRMC comparative effectiveness study is mentioned for the expanded indication of soft tissue dissection. The review pathway is based on substantial equivalence to predicate devices through non-clinical testing.

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

The Avéli device is a powered surgical instrument used by a human operator, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For the expanded indication of soft tissue dissection, the "ground truth" for the non-clinical tests is represented by the design specifications, performance requirements, and relevant international standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) that the device was tested against. The tests verify that the device performs as intended and meets these established engineering and regulatory benchmarks.

For the cellulite indication, the ground truth would likely have been based on clinical assessment of appearance reduction (e.g., by investigators or independent evaluators) as stated by "clinical data demonstrating treatment benefits." However, the details of this ground truth establishment are not provided here.

8. The Sample Size for the Training Set

No training set is mentioned in the context of this device. The Avéli is a physical surgical instrument, 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 mention of a training set for this device.

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Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation.

Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook next to fibrous septa captures the septa resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the fibrous septa. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all contributing septa have been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression.

Here's a summary of the acceptance criteria and study details for the Avéli device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: 74 participants.
   • Data Provenance: Prospective, multi-center study conducted across nine (9) investigational sites in the US and Australia.

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

   • Number of Experts: Three (3) independent physician evaluators.
   • Qualifications: The text states they were "independent physician evaluators." Further specific qualifications (e.g., years of experience, specialization) are not provided in the document.

3. Adjudication method for the test set:

   • The three independent physician evaluators were "individually trained, and monitored throughout the evaluation." They were provided blinded before (baseline) and after photographs side by side in randomized orientation (L-R) and asked to identify baseline/after photos and rate improvement using GAIS and CSS. The document states "All reliability and repeatability measures were met at 3 months and validated the methodology." This implies a consensus or agreement was reached amongst the evaluators, but the specific adjudication rule (e.g., majority vote, specific statistical agreement threshold) is not detailed.

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:

   • No. This was a clinical study evaluating the device's effectiveness in patients, with independent physician evaluators assessing photographs of those patients. It was not an MRMC study comparing human readers with and without AI assistance.

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

   • No. The Avéli device is a manual surgical instrument. The study evaluated its clinical performance in patients, with human physician evaluators assessing the outcomes. There is no mention of an algorithm or AI component.

6. The type of ground truth used:

   • Expert Consensus/Independent Assessment: The primary effectiveness endpoint was determined by "independent, blinded physician evaluators comparing baseline and 3-month photos" using the Cellulite Severity Score (CSS) and Global Aesthetic Improvement Scale (GAIS).

7. The sample size for the training set:

   • The document describes a pivotal clinical study and does not mention a separate "training set" for an algorithm. The 74 participants were part of the clinical study to evaluate the device itself.

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

   • Not applicable, as no algorithm training set is described. The clinical study's ground truth was established by independent physician evaluators as detailed above.

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Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.

Avéli is a sterile, single-use manual instrument that cuts fibrous tissue (septa) beneath moderate to severe cellulite for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a handle and a distal end. The handle houses components used to actuate the moving parts at the distal end of the device. The distal end of the device is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The distal end of the device contains a blunt link and a sharpened link forming a distal hook. When the handle is moved in a retrograde fashion, the distal hook next to a fibrous septum captures the septum resulting in tugging. The user feels the resistance, confirming that a septum under a cellulite depression has been identified. The user then engages a sharpened link to be exposed at the distal end of the device. The user applies additional retrograde motion to sever the fibrous septum, and then retracts the sharpened link and the blunt link into the device, allowing removal without further tissue capture. The step is repeated for each visible cellulite depression.

The manufacturer, NC8, Inc. (now Revelle Aesthetics, Inc.), performed a clinical study to evaluate the safety and effectiveness of the Avéli device for the treatment of cellulite. The study involved a prospective, non-randomized, multi-center design across nine investigational sites.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample Size for Test Set: The text states "All participants served as their own control." While the exact number of participants is not explicitly given as a single number for the "test set" in the context of an algorithm, it refers to the participants in the pivotal clinical study. The study included "females between the ages of 26 and 54 with moderate to severe cellulite and BMI between 19 and 30." The images of these participants collected before and 3-months after the procedure would constitute the data used for evaluation.
• Data Provenance: The study was a "prospective, non-randomized, multi-center study conducted to evaluate the safety and effectiveness of Avéli." The text does not specify the country of origin, but given the FDA submission, it is highly likely it was conducted in the United States or followed international standards acceptable to the FDA. The data is prospective.

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

• Number of Experts: Three (3)
• Qualifications of Experts: "Independent, blinded physician evaluators." (Further specific qualifications like years of experience or specialty, e.g., dermatology, plastic surgery, are not provided).

4. Adjudication method for the test set

• The text describes the effectiveness evaluation as being "determined by three independent, blinded physician evaluators." This implies a form of consensus or independent grading from multiple readers. However, a specific adjudication method (e.g., 2+1, 3+1, majority vote if there were discrepancies, or average score) is not explicitly stated. It just says it was "determined by" the three evaluators.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study evaluated the effectiveness of the device (Avéli) in treating cellulite, not an AI algorithm assisting human readers. The evaluators assessed patient photographs to determine the device's efficacy.

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

• No, a standalone algorithm performance study was not done. The primary effectiveness endpoint was based on human evaluators assessing photographs, which is a human-in-the-loop assessment of the device's effectiveness, not an algorithm's.

7. The type of ground truth used

• The ground truth for effectiveness was based on expert consensus/opinion from physician evaluators assessing before and after photographs, specifically the "mean change (improvement) in the Cellulite Severity Score (CSS)." The "Cellulite Severity Score" itself is a clinical assessment tool.

8. The sample size for the training set

• The document does not mention a training set or any machine learning/AI component for which a training set would be required. The clinical study described is for the Avéli device itself, which is a manual surgical instrument, not an AI-powered diagnostic or treatment planning system. Therefore, the concept of a "training set" for an algorithm is not applicable here.

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

• As there is no mention of an algorithm or training set, this information is not applicable to the provided text.

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The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).

Here's a breakdown of the acceptance criteria and study details for The Cellfina System, based on the provided text:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device 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 for Test Set:

  • 55 subjects participated in the baseline assessment and treatment.
  • Follow-up progressively decreased: 3 Day (55), 14 Day (54), 1 Month (54), 3 Month (55), 6 Month (52), 1 year (50), 2 year (52), 3 year (45), 5 year (37). The primary and secondary endpoints are reported at 5 years, so the effective sample size for the long-term evaluation is 37.

• Data Provenance:

  • Study Design: Prospective, multi-center, non-randomized open label, safety and effectiveness study.
  • Country of Origin: Not explicitly stated in the provided text, but "multi-center" implies it was conducted at several clinical sites.

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 text refers to "independent physician assessment" for determining the Cellulite Severity Scale and classifying improvement. However, it does not specify the number of physicians or their specific qualifications (e.g., years of experience, specialty).

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

• The text states "independent physician assessment." It does not explicitly describe an adjudication method like 2+1 or 3+1 (where multiple readers might assess independently and then a tie-breaker or consensus is used). It implies individual independent assessments were used to determine the Cellulite Severity Scale and photographic improvement.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance was not done. The Cellfina System is a physical medical device (powered surgical instrument) for treating cellulite, not an AI-powered diagnostic or assistive tool. The assessments described are of the device's clinical efficacy on patients, conducted by physicians.

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

• No, a standalone (algorithm only) performance study was not done. As mentioned, The Cellfina System is a physical medical device, not an algorithm or AI. The study evaluated the device's performance in patients.

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

• The ground truth for effectiveness was primarily established by independent physician assessment of subject photographs, utilizing a Cellulite Severity Scale and classifying improvement grades.
• For safety, it was based on outcomes data regarding the absence of Serious Adverse Events (SAE) attributable to the device or procedure.
• Additionally, patient-reported outcomes (GAIS, satisfaction, pain levels) were also collected as secondary measures.

8. The sample size for the training set

• The provided document describes a clinical study to evaluate the performance of the Cellfina System. It does not mention a "training set" in the context of an algorithm or AI model development. Therefore, no information is available on a "training set sample size" as this device is not an AI/ML product.

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

• Since the device is not an AI/ML product, there is no "training set" or "ground truth for the training set" as would be applicable to such products. The clinical study described is for evaluating the device's clinical performance directly.

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The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 3 years of observation.

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).

Here's an analysis of the provided text to extract the acceptance criteria and study details for "The Cellfina System":

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 55 subjects participated in the baseline assessment and treatment.
   • Follow-up at 3 years: 45 subjects completed the 3-year follow-up.
   • Data Provenance: The study was a "Prospective, multi-center, non-randomized open label, safety and effectiveness study." This indicates it was a prospective study, typically conducted in multiple clinical sites (country of origin is not explicitly stated, but often such trials for FDA approval are largely US-based unless otherwise specified).
   • Imputation: For the 10 subjects lost to follow-up at 3 years, "last observation carried forward (LOCF)" was used for both primary and 1st secondary endpoints, and "multiple imputation" for the primary effectiveness endpoint.

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

   • The primary and secondary endpoints were determined by "independent physician assessment of subject photographs." The exact number of independent physicians (experts) is not specified in the provided text. Their specific qualifications (e.g., "radiologist with 10 years of experience") are also not detailed, beyond being "independent physicians."

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

   • The adjudication method is not explicitly described in the provided text. It only mentions "independent physician assessment." This could imply a single independent assessor or a consensus method, but the specific process (e.g., if multiple physicians' assessments were averaged or if a tie-breaking mechanism was used) is not detailed.

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:

   • No, an MRMC comparative effectiveness study was not done. This study evaluates a device (The Cellfina System) for treating cellulite, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.

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

   • No, this device is a powered surgical instrument, not an algorithm. The performance detailed here is for the physical device and procedure, with human physicians performing the assessment.

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

   • The ground truth for effectiveness was established primarily through expert assessment/consensus based on photographs ("independent physician assessment of subject photographs").
   • Safety was based on outcomes data (absence of Serious Adverse Events reported).
   • Subject satisfaction and pain levels were based on patient-reported outcomes.

7. The sample size for the training set:

   • Not applicable. This study is for a medical device (a powered surgical instrument), not a machine learning model. There is no concept of a "training set" in this context. The clinical study described served as the validation and effectiveness study for the device itself.

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

   • Not applicable, as there is no training set for a medical device of this nature.

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The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation.

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1).

The provided text is related to a 510(k) summary for the Cellfina System and discusses an extension of shelf life and labeling changes. It repeatedly refers to the predicate device (K150505) for clinical trial data and other non-clinical tests. Therefore, the details regarding acceptance criteria and the study proving the device meets those criteria are primarily found by referencing the K150505 submission, which is not fully included in this document.

However, based on the information provided in the current document (K153677) and the references within it, here's what can be extracted and inferred:

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

The provided document (K153677) is a Special 510(k) for a shelf-life extension and labeling changes. It states that the clinical effectiveness and safety data from the predicate device (K150505) are applicable. Thus, the acceptance criteria for the effectiveness of the device are derived from the clinical data demonstrating "long term improvement in the appearance of cellulite... up to 2 years of observation" as stated in the Indications for Use.

For the specific changes submitted in K153677 (shelf-life extension), the acceptance criteria are related to the stability and performance of the device after aging. The document states:

Note on Clinical Performance from Predicate Device (K150505) as inferred from Indications for Use:

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

The current document (K153677) does not provide this information directly as it refers to the predicate device (K150505) for "in-vivo evaluation (clinical trial data)". For the shelf-life extension, the "test set" for performance evaluation consists of "12 month aged product" for the CK1 disposable kit. The sample size for this testing is not specified. The data provenance for the clinical trial would be available in the K150505 submission.

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 K153677 document, as it defers to the predicate device (K150505) for clinical data. The clinical trial data for the original device approval would have involved assessments by qualified medical professionals (e.g., dermatologists, plastic surgeons) to determine the improvement in cellulite appearance.

4. Adjudication method for the test set

This information is not explicitly provided in the K153677 document. The adjudication method for assessing clinical outcomes (e.g., improvement in cellulite appearance) would have been specified in the clinical trial protocol referenced in the K150505 submission.

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 Cellfina System is a powered surgical instrument for treating cellulite, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, a MRMC study involving "human readers" and "AI assistance" would not be relevant.

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

This is not applicable. The Cellfina System is a physical device used by a physician (human-in-the-loop) to perform a surgical procedure. It is not an algorithm performing a task without human intervention.

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

For the clinical effectiveness of the device (as inferred from K150505 via the Indications for Use), the ground truth for "improvement in the appearance of cellulite" would likely be based on:

• Expert assessment: Clinical evaluators (e.g., physicians) making subjective and/or objective assessments of cellulite severity before and after treatment.
• Patient outcomes data: Patient satisfaction and self-assessment of their cellulite appearance.
• Possibly photographic evidence: Standardized photographs evaluated by blinded experts.

For the shelf-life extension (K153677), the ground truth is based on engineering and performance testing to ensure the device components meet specifications after aging.

8. The sample size for the training set

This is not applicable in the context of an algorithm training set, as the Cellfina System is a medical device for direct treatment, not an AI/ML model being trained. If "training set" refers to the subjects in the original clinical study (K150505), that information is not provided here.

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

Not applicable for the same reasons as point 8.

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The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 vears of observation.

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The release of subcutaneous tissue for improvement in the appearance of cellulite is a minimally invasive surgical technique by physicians using of manual surgical instruments and accessories. The Cellfina device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the tissue release. The system consists of a sterile single use disposable kit and a non-sterile reusable motor module.

The provided text describes specific acceptance criteria and performance data for the Cellfina™ System, a device intended for the improvement of the appearance of cellulite.

Here's a breakdown of the requested information:

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

Additional Secondary Measures Achieved:

• Correct Selection by Independent Physician Assessment: Average rate of correct selection of blinded subject photographs (before and two years after treatment) was 98.1% (95% confidence limit of 94.5%).
• Noticeable Improvement (GAIS) and Marked Improvement: 100% of subjects had noticeable improvement by the Global Aesthetic Improvement Scale (GAIS). 52% were characterized as having marked improvement or better by independent physician assessment.
• Subject Satisfaction: 96% of subjects were either satisfied or very satisfied at the 2-year follow-up.
• Subject Reported Pain: Average pain on a 0-10 numerical rating scale was 4.5 for anesthesia delivery and 3.7 for tissue release. At follow-ups, 71% of subjects rated pain ≤ 3 at 3 days, and over 95% rated pain ≤ 3 thereafter. No subjects reported pain at the 2-year follow-up.

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

• Sample Size for Test Set: The document indicates that "All subjects served as their own control" and mentions endpoints being achieved for "all subjects." However, the exact number of subjects in the pivotal clinical study (test set) is not explicitly stated in the provided text.
• Data Provenance: The study was a "prospective, multi-center, non-randomized open label, safety and effectiveness study." The location (country of origin) of the study centers is not specified, but it was conducted under IDE G120116.

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

• Number of Experts: An "independent and blinded reviewer of the photographs" was used to verify effectiveness, and "independent physician assessment" determined the reduction in cellulite severity and grade improvement. The exact number of independent physicians/reviewers is not specified.
• Qualifications of Experts: The text refers to "independent physician assessment." No further details on their specific qualifications (e.g., specialty, years of experience) are provided.

4. Adjudication method for the test set

• The document mentions an "independent and blinded reviewer" for photographs to verify effectiveness. For the primary and powered secondary endpoints, "independent physician assessment" was used. The text does not explicitly detail an adjudication method (e.g., 2+1, 3+1) if there were multiple independent assessments or if there were disagreements. It implies a single "independent physician assessment" for each metric.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on AI assistance for human readers was not mentioned. The study evaluated the effectiveness of the Cellfina System itself, not an AI assistant.

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

• No, a standalone (algorithm only) performance study was not mentioned. The Cellfina System is a physical device that is used by physicians, and the study evaluated its direct clinical performance on patients.

7. The type of ground truth used

• The ground truth was established through expert consensus/assessment of clinical data. This included:
  • Independent physician assessment of subject photographs (before and 2 years after treatment) for cellulite severity and grade improvement.
  • Global Aesthetic Improvement Scale (GAIS) based on independent physician assessment.
  • Subject-reported satisfaction and pain levels.
  • Adverse event reporting.

8. The sample size for the training set

• The text does not mention a separate "training set" in the context of device development or any machine learning/AI models. The clinical study described is a pivotal trial evaluating the device's safety and efficacy.

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

• As no "training set" (in the context of AI/machine learning) is described, this question is not applicable based on the provided text. The clinical study described served as the basis for demonstrating the device's effectiveness.

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The Cabochon System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 1 year of observation.

The Cabochon System is the same (identical) device as the legally marketed predicate and intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The release of subcutaneous tissue for improvement in the appearance of cellulite is a minimally invasive surgical technique by physicians using a variety of manual surgical instruments and accessories. The Cabochon device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the area of the tissue release.

The Cabochon System is intended for long-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 55 subjects.
• Data Provenance: Prospective, multi-center, non-randomized open-label safety and effectiveness study conducted in 3 US centers.

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

• The document implies that the ground truth for the primary and powered secondary endpoints (Cellulite Severity Scale and grade improvement) was established by independent physician assessment of subject photographs.
• The document also refers to independent physician assessment for the overall study success criteria, GAIS, and correct selection of photographs.
• The qualifications of these experts are not explicitly stated beyond being "independent physicians."

4. Adjudication method for the test set:

• The document mentions "independent and blinded review of the photographs." While it specifies "independent physician assessment," it does not explicitly state a formal adjudication method like 2+1 or 3+1 for discrepancies in evaluation. It is implied that the assessment contributed to the reported metrics.

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, an MRMC comparative effectiveness study involving AI assistance was not done. The study evaluated the Cabochon System (a medical device for cellulite treatment) and its effectiveness, not an AI system.

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

• No, a standalone algorithm-only performance study was not done. The Cabochon System is a powered surgical instrument, not an AI algorithm. Its performance was evaluated through clinical trials involving human subjects, physicians, and their assessments.

7. The type of ground truth used:

• The ground truth was based on expert consensus/assessment (independent physician assessment) of subject photographs against established clinical scales (Cellulite Severity Scale, severity grades, Global Aesthetic Improvement Scale). It was observational and subjective assessment by experts.

8. The sample size for the training set:

• Not applicable. The Cabochon System is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the device would involve physician training on its use, but this is not reflected as a data "training set" for an algorithm.

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

• Not applicable, as there is no mention of an algorithm or training set in the context of this device's regulatory submission.

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The Cabochon System is intended for the short-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females.

The Cabochon System temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples. The release of subcutaneous tissue for improvement in the appearance of cellulite is a surgical technique currently performed by physicians using a variety of manual surgical instruments. The depth and specific area of release achieved with the manual surgical instruments are generally variable and user-dependent. The Cabochon System has been designed to provide added control over both the depth and area of release.

This document describes the De Novo Classification Request for the Cabochon System, a powered surgical instrument intended to improve the appearance of cellulite. Below is a summary of the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 55 subjects.
• Data Provenance: Prospective, multi-center study conducted in 3 US centers.

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

• Number of Experts: Three independent physician evaluators.
• Qualifications: The document states they were "independent physician evaluators," but does not explicitly detail their specific qualifications (e.g., years of experience or specialty like a radiologist). They were "individually trained, and monitored throughout the evaluation."

4. Adjudication Method for the Test Set

• The document describes a blinded evaluation process where "blinded before (baseline) and after photographs were provided side by side in randomized orientation (L-R)" to the three independent physician evaluators.
• The evaluators were asked to "identify the baseline and after photographs, rate the overall improvement... according to a Global Aesthetic Improvement Scale (GAIS)."
• The overall study success criteria involved statistically significant changes as determined by this independent physician assessment. While not explicitly stated as a consensus or majority vote (like 2+1 or 3+1), the independent assessment by three evaluators and the statistical analysis of their ratings served as the adjudication method for effectiveness endpoints. "All reliability and repeatability measures were met and validated the methodology."

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of comparing human readers with AI assistance. This device is a surgical instrument, not an AI diagnostic tool. The "readers" were human physician evaluators assessing photographs of patients treated by the device, not interpreting images or data generated by an AI.

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

• No, a standalone algorithm-only performance study was not done. The device is a physical surgical instrument; it incorporates no software or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for effectiveness was established through a combination of:
  • Expert Consensus/Independent Physician Assessment: Three independent physician evaluators assessed "blinded before (baseline) and after photographs" to determine perceived improvement in cellulite appearance and severity. They used a Global Aesthetic Improvement Scale (GAIS) and a 0-5 point Cellulite Severity Scale.
  • Subject Reported Outcomes: Subject satisfaction and subject-reported pain levels were also collected.
• For safety, the ground truth was based on reported adverse events (or lack thereof) monitored by a Data Safety Monitoring Board (DSMB).

8. The Sample Size for the Training Set

• The document mentions "Feasibility clinical testing... in 1 outside the US (OUS) and 1 US center where 56 subjects received treatment with the device with follow-up out to 1-year in the US site."
• "Data from the feasibility study was also used to develop an appropriate pivotal study."
• This suggests the 56 subjects from the feasibility study might have served as a "training set" in a broad sense, used to refine the device and study protocol before the pivotal study. However, this is not a "training set" in the context of machine learning, as the device does not employ AI.

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

• Given that the "training set" refers to the feasibility study, the ground truth was likely established through similar means as the pivotal study:
  • Observation of safety events (adverse events).
  • Assessment of effectiveness endpoints (though possibly with different scales or methods, as it was used to "develop an appropriate pivotal study," implying refinement).
  • It is explicitly stated that "the effectiveness endpoints were achieved" in the feasibility study.

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