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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 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 for use on the flanks.

The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape 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 System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The UltraShape System has two treatment modes available, the Single Focus Deep Mode and the Super Mode.

The Synergy UltraShape System, a focused ultrasound stimulator for aesthetic use, was evaluated for safety and effectiveness in non-invasive lipolysis of the flanks. The device delivers focused ultrasound energy to disrupt subcutaneous adipose tissue (SAT) for fat breakdown.

Here's a breakdown of the acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 48 subjects were enrolled and treated in the study, with 46 subjects completing the study. The primary endpoint assessment was based on 45 subjects due to the poor quality of one post-treatment photograph.
• Data Provenance: The study was a prospective, single-arm, self-controlled, multicenter clinical study conducted at 3 U.S. sites. The data is thus prospective and from the U.S.

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

• Number of Experts: 2 blinded reviewers.
• Qualifications: The document does not explicitly state the specific qualifications (e.g., radiologist, years of experience) of the blinded reviewers. It only specifies that they were "blinded reviewers."

4. Adjudication Method for the Test Set

• The primary endpoint was met "by agreement between the blinded reviewers." This implies a consensus-based adjudication, specifically that both reviewers had to agree on the correct identification of pre/post-treatment and treated/untreated flanks.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as being performed to evaluate human reader improvement with or without AI assistance. This study focused on the device's efficacy in achieving fat reduction through visual assessment and physical measurements, not the performance of human readers assisted by AI.

6. Standalone (Algorithm Only) Performance

• This study did not focus on standalone algorithm performance. The UltraShape System is a device for physical treatment and relies on visual and measurement assessments by human observers (investigators, subjects, blinded reviewers) and physical measurement tools (ultrasound, caliper) to determine its effectiveness. While the device has software components for control and guidance, the performance evaluation is for the device's physical effect on the body, not a diagnostic algorithm.

7. Type of Ground Truth Used

• The ground truth for the primary endpoint was established by expert consensus (agreement between 2 blinded reviewers) on photographic assessments.
• For secondary endpoints, objective measurements (ultrasound, caliper) were used to quantify fat thickness reduction, and subjective assessments (investigator and subject satisfaction, comfort level) were collected.

8. Sample Size for the Training Set

• The document refers to "several separate prospective studies" for clinical evaluation and states that nonclinical performance testing was "previously conducted" and "In vivo testing in an animal model was performed." However, it does not explicitly state a separate "training set" for the UltraShape System's clinical evaluation in the context of this 510(k) submission. The clinical data presented here is the definitive study for the device's substantial equivalence to the predicate. The UltraShape System itself is a physical device, and its "training" might refer to development phases or prior versions, but not a dataset for an AI algorithm in the way it's typically understood. The presented clinical study is the test set for this specific submission's claims.

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

• As noted above, a distinct "training set" for the clinical effectiveness of this specific device version isn't detailed in the same manner as an AI algorithm's training data. The device's development and prior clearances (K141708, K133238, K160896) would have involved extensive R&D and testing, where engineers and clinicians established desired performance characteristics. The nonclinical testing (biocompatibility, beam profile, acoustic power, thermal measurements, software verification, electrical safety, in vivo animal testing) described in the document served to validate the device's core functionality and safety prior to humanitarian clinical trials. The "ground truth" for these aspects would be derived from laboratory measurements, adherence to standards, and observation of physical effects.

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