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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 a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.

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.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Sample Size: 47 subjects (all female).
   • Data Provenance: Prospective, single-arm, self-controlled, multicenter clinical study conducted at 3 U.S. sites.

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

   • Number of Experts: 2 blinded reviewers.
   • Qualifications: The document does not specify the qualifications of the blinded reviewers (e.g., radiologist with X years of experience). It only states they were "blinded reviewers."

4. Adjudication Method for the Test Set:

   • The device performance indicates that the primary endpoint was met by "agreement between the blinded reviewers." This implies a consensus-based adjudication method, likely 2 out of 2 agreement, for the visual assessment of photographs.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study design was a prospective, single-arm, self-controlled study rather than a comparative effectiveness study comparing AI with and without human assistance. The primary endpoint involved human reviewers assessing photographs, but it was for standalone device effectiveness, not to measure human improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, this study was not a standalone (algorithm only) performance study. The primary effectiveness endpoint relied on assessment by "blinded reviewers" of photographs, which inherently involves human-in-the-loop performance for evaluation.

7. Type of Ground Truth Used:

   • The primary ground truth for the effectiveness endpoint was expert consensus (agreement between the two blinded reviewers) based on visual assessment of photographs of pre- and post-treatment thighs, as well as treated vs. untreated thighs.
   • Secondary endpoints used objective measurements like ultrasound and caliper measurements for fat thickness reduction, and investigator and subject satisfaction assessments.

8. Sample Size for the Training Set:

   • The document describes a clinical study to evaluate the device, not an AI or algorithm, so there is no mention of a "training set" in the context of machine learning. The clinical study itself served to demonstrate the device's performance in humans.

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

   • Not applicable, as this is not an AI/machine learning device that would require a separate training set with established ground truth. The study evaluated the direct effects of the UltraShape System on human subjects.

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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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The UltraShape 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 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 transducer is an electro-mechanical device that converts 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 purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.

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

Device: Syneron UltraShape System
Intended Use: The UltraShape 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.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes the effectiveness (circumference reduction) and safety outcomes that demonstrate the device's performance met the requirements for substantial equivalence.

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

• Sample Size (Effectiveness & Safety Studies): 102 enrolled subjects (across "two, separate, prospective, single arm studies").
• Sample Size (Additional Safety Study): 21 patients.
• Data Provenance: The document does not explicitly state the country of origin of the data. The submitter, Syneron Medical Ltd., is located in Yokneam Illit, Israel. The studies were prospective clinical evaluations.

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

The provided text does not specify the number of experts used to establish a "ground truth" for the test set or their qualifications. The study primarily evaluated objective measurements (circumference reduction, weight) and patient-reported outcomes (satisfaction, adverse events) rather than expert interpretation of images or other data requiring "ground truth" consensus in the typical sense.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given the primary endpoints were objective measurements (circumference reduction) and patient-reported outcomes (satisfaction, adverse events), an adjudication process like "2+1" or "3+1" (common for expert interpretation of medical images) would not be directly applicable. Adverse events were likely reported and categorized by the clinical investigators.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies were "single arm studies" and focused on the performance of the UltraShape device itself, not on comparing it to human reader performance or assessing human reader improvement with AI assistance. The device is a direct treatment modality, not an AI diagnostic aid for human interpretation.

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

Yes, the clinical studies described evaluate the standalone performance of the UltraShape System as a treatment device. This device is not an algorithm for diagnosis or interpretation that would typically involve a "human-in-the-loop" for performance evaluation. Its efficacy is measured directly by its effect on abdominal circumference and its safety profile.

7. The Type of Ground Truth Used

The "ground truth" for effectiveness was based on objective anatomical measurements (abdominal circumference reduction) and patient-reported outcomes data (satisfaction, discomfort). For safety, it was based on adverse event reporting and assessment.
It was not based on expert consensus, pathology, or direct "ground truth" in the diagnostic sense.

8. The Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This is because the UltraShape System is a physical medical device that delivers focused ultrasound energy, not an AI/ML algorithm that requires a training dataset in the conventional sense. The "training" for such devices involves rigorous engineering, design, and internal testing before clinical studies.

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

As stated above, this device is not an AI/ML algorithm that relies on a "training set" with ground truth in the typical fashion of machine learning. Therefore, the concept of establishing ground truth for a training set is not applicable to this device. Any "ground truth" for its development would be engineering specifications, physical principles, and non-clinical testing results (e.g., beam profile, acoustic power, in vitro and in vivo animal studies).

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