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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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