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The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.

The UltraShape Power System is comprised of multiple components, including the control unit and an ultrasonic transducer. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

Here's a breakdown of the acceptance criteria and study information for the UltraShape Power System, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The document describes two separate clinical studies, one for the flanks and one for the thighs.

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

• Flanks Study:
  • Sample Size: 48 subjects enrolled and treated (46 completed the study).
  • Data Provenance: Prospective, multi-center clinical study conducted at 3 U.S. sites.
  • Test Set Description: Each subject received 3 biweekly treatments on one randomized flank, while the other flank remained un-treated throughout the study (serving as an internal control). Follow-up was at 4, 8, and 16 weeks after the last treatment. Comparisons were made between treated vs. control flanks and pre- vs. post-treatment.
• Thighs Study:
  • Sample Size: 47 subjects enrolled.
  • Data Provenance: Prospective, multi-center clinical study conducted at 3 U.S. sites.
  • Test Set Description: Each subject received 3 biweekly treatments on one randomized thigh, while the other thigh remained un-treated (serving as an internal control). Follow-up was at 4, 8, and 16 weeks after the last treatment. Comparisons were made between treated vs. control thighs and pre- vs. post-treatment.

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

• Number of Experts: 2 blinded reviewers were used for both the flanks and thighs studies.
• Qualifications: The specific qualifications of the reviewers (e.g., dermatologists, plastic surgeons, years of experience) are not explicitly stated in the provided text. They are simply referred to as "blinded reviewers."

3. Adjudication method for the test set

• Adjudication Method: For both flanks and thighs studies, the primary endpoint was considered met if the reviewers "identified correctly (by agreement between the blinded reviewers)" the pre-/post-treatment and treated/un-treated images. This indicates that agreement between the two reviewers was required for a successful identification. This can be considered a form of "consensus" adjudication.

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 involving AI assistance was NOT done. The studies described evaluate the device's efficacy in achieving fat reduction, with visual assessment by human reviewers as one endpoint. The device itself is for fat reduction, not for diagnostic assistance that would typically involve AI.

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

• Not applicable. The UltraShape Power System is a medical device that delivers focused ultrasound energy for lipolysis. It is not an AI algorithm for diagnostic purposes. The evaluation is of the direct physical effect of the device on the body.

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

• For Efficacy (Fat Reduction):

  • Visual Assessment: Expert consensus (agreement between 2 blinded reviewers) on identifying treated vs. control and pre- vs. post-treatment photographs.
  • Objective Measurements: Pathology (not directly, but indirectly by measuring fat thickness reduction via ultrasound and caliper, which are objective clinical measurements representing the outcome of lipolysis).
  • Outcomes Data: Investigator satisfaction, subject satisfaction, and comfort level self-assessments were also gathered as secondary outcomes.

• For Safety: Clinical observation of adverse events and immediate responses.

7. The sample size for the training set

• Not applicable. The provided text describes clinical studies evaluating a physical medical device. It does not mention a "training set" in the context of an AI algorithm. The device's technological characteristics and settings (frequency, burst duration, node duration, user interface, power intensity levels, focal distribution) were "previously cleared" or "previously conducted" in relation to predicate devices, implying prior developmental testing and optimization, but not necessarily a "training set" in the machine learning sense.

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

• Not applicable. As the concept of a "training set" for an AI algorithm is not relevant here, the establishment of ground truth for such a set is also not discussed. The clinical studies aim to demonstrate the device's effectiveness and safety, not to train an algorithm.

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The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

The UltraShape Power System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

The primary purpose of this submission is to add an increased acoustic intensity level to the device. Additional minor changes since the prior clearances were also included as part of this submission.

The UltraShape Power System is a medical device designed for non-invasive reduction of abdominal circumference by disrupting subcutaneous adipose tissue (SAT) using focused ultrasound energy.

1. Acceptance Criteria and Reported Device Performance:

The primary efficacy endpoint for the UltraShape Power System was the reduction in abdominal circumference and fat thickness. While specific acceptance criteria for "statistically significant" were not explicitly detailed in terms of a numerical threshold, the study's results demonstrated strong positive outcomes.

2. Sample Sizes and Data Provenance:

• Test Set (Clinical Evaluation):

  • Main Study: 43 enrolled subjects.
  • Additional Safety Study: 21 patients.
  • Data Provenance: Not explicitly stated, but the submission is from Syneron Medical Ltd. (Israel), and the study likely took place in a clinical setting related to their operations. It can be inferred to be prospective as it describes recruitment, treatment, and follow-up over specified time periods.
  • Demographics (Main Study): Mean age 48 years, 95% female, all Caucasian.

• Training Set: Not applicable for this type of device and study. The studies described are clinical trials for safety and effectiveness, not for training a machine learning algorithm.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in the context of this device. The "ground truth" for efficacy was objective measurements (abdominal circumference, fat thickness) and patient-reported outcomes (satisfaction, comfort). These do not require expert consensus in the same way an imaging diagnostic device might.

4. Adjudication Method:

Not applicable. The study utilized objective physical measurements and patient self-assessment questionnaires, not the adjudication of expert interpretations.

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

No. This was a standalone clinical evaluation of a physical device for aesthetic purposes, not a diagnostic imaging device requiring expert interpretation.

6. Standalone Performance (Algorithm Only):

Yes, in a sense. The described clinical studies (43 subjects, 21 patients) evaluate the device only without human-in-the-loop performance influencing the primary efficacy outcomes. The device is operated by a healthcare professional, but the effectiveness measurements (circumference, fat thickness reduction) are direct outcomes of the device's action on the body, not a human interpretation of an algorithm's output.

7. Type of Ground Truth Used:

• Efficacy:
  • Objective Measurements: Abdominal circumference reduction (measured physically).
  • Objective Measurements: Fat thickness reduction (presumably measured by imaging, though the method isn't specified, it's an objective physical change).
• Safety: Observational data for adverse events and patient-reported comfort/discomfort.
• Patient Satisfaction: Self-reported patient satisfaction and willingness to recommend.

8. Sample Size for the Training Set:

Not applicable. This is not a device driven by a machine learning algorithm that requires a training set in the conventional sense.

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

Not applicable.

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