(290 days)
The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.
The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.
The provided text describes a 510(k) premarket notification for the Mentor® Contour Genesis System, a device for ultrasound-assisted lipoplasty. It references a clinical study conducted to demonstrate substantial equivalence to a predicate device. However, the document does not present specific acceptance criteria in a table format with reported device performance against those criteria. It also doesn't detail the study information in the structured way requested.
Based on the information provided, here's what can be extracted and inferred, along with the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative or tabular format. Instead, it compares the new device (UAL) to a predicate device (SAL) based on safety and effectiveness measures.
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance (Mentor® Contour Genesis System - UAL) | Reference / Comment |
|---|---|---|
| Safety: Similar proportion of subjects reporting any adverse event compared to SAL. | Proportion of subjects reporting any adverse event: 18.8%. This was statistically equivalent to the SAL group. | The study aimed to show equivalence in safety outcomes. |
| Effectiveness (Overall Satisfaction): Similar overall satisfaction rate compared to SAL. | Overall satisfaction rate: 90.3% | Compared to 95.2% in the SAL group. While not explicitly stated as 'equivalent,' the narrative implies it was considered acceptable for substantial equivalence. |
| Effectiveness (Improved feelings towards treated body area): Statistically significant improvement. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
| Effectiveness (Improved self-esteem): Statistically significant improvement as measured by Rosenberg Self-Esteem scale and Body Esteem scale. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
| Effectiveness (Improved body contour measurements): Statistically significant improvement as assessed by a masked reviewer. | Statistically significant improvement reported. | Specific p-value or effect size not provided. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set:
- Total subjects enrolled: 366
- UAL patients (test group): 180
- SAL patients (control group): 186
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical study comparing two treatments for a 510(k) submission, it is highly likely to be a prospective study. The country of origin is not specified, but typically for FDA submissions, studies are often conducted in the US or follow international clinical trial standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document mentions "a masked reviewer" assessed body contour measurements.
- It does not specify the number of experts (beyond "a masked reviewer"), their qualifications (e.g., radiologist with X years of experience), or how they established the 'ground truth' for other measures like satisfaction or self-esteem (which are patient-reported outcomes).
4. Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For patient-reported outcomes like satisfaction and self-esteem, adjudication is typically not applicable as the patient's report is the primary data. For body contour measurements, "a masked reviewer" implies a single assessment, not a consensus or adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This study was a clinical comparative effectiveness study, but specifically comparing device performance (UAL vs. SAL lipoplasty), not a multi-reader multi-case study comparing human readers with and without AI assistance.
- Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this document as it's not an AI device.
6. Standalone (Algorithm Only) Performance:
- This is not an AI device, so standalone algorithm performance is not applicable. The study evaluates the performance of a medical device (Mentor® Contour Genesis System) used by a surgeon.
7. Type of Ground Truth Used:
- Primary Safety Measures: Adverse events (patient-reported and/or clinician-observed).
- Secondary Effectiveness Measures:
- Patient-reported overall satisfaction.
- Patient-reported feelings towards each body area treated.
- Patient-reported self-esteem (using Rosenberg Self-Esteem scale and Body Esteem scale).
- Body contour measurements as assessed by a masked reviewer.
8. Sample Size for the Training Set:
- The document describes a clinical study to compare the device, which serves as the test set for demonstrating equivalence. It does not mention a separate training set for the device itself. This device is a physical medical system (ultrasonic generator, handpiece, etc.), not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- As this is not an AI/ML device, a separate training set and its associated ground truth establishment are not applicable.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.