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510(k) Data Aggregation
(233 days)
Aesthetic Body Contouring
The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.
The provided FDA 510(k) summary for the Vitruvian Liposaber pertains to a suction lipoplasty system, which is a physical device used for aesthetic body contouring. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and comparison of technical specifications, rather than clinical studies involving human patients or AI performance metrics.
Therefore, the requested information regarding AI acceptance criteria, specific study designs (MRMC, standalone), human reader performance improvement, multi-expert ground truth establishment, training and test set sample sizes for AI, and adjudication methods is not applicable to this device and its 510(k) submission.
The document explicitly states: "No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non-clinical testing details in this submission support the substantial equivalence of the device." This confirms that the approval is based on equivalence to existing, commonly understood devices, not on novel AI performance.
Below is a summary of the acceptance criteria and device performance as demonstrated in this 510(k) in the context of the device's technical specifications and non-clinical testing.
Acceptance Criteria and Reported Device Performance (Non-Clinical) for Vitruvian Liposaber™
The Vitruvian Liposaber™ is a physical medical device (suction lipoplasty system). Its acceptance criteria and performance are demonstrated through comparison to a predicate device and non-clinical testing, as opposed to AI performance metrics.
1. Table of Acceptance Criteria (as implied by comparison to predicate and non-clinical testing) and the Reported Device Performance:
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Subject Device: Vitruvian Liposaber™) |
|---|---|
| Intended Use Equivalence: Aesthetic Body Contouring | Aesthetic Body Contouring (Same as Predicate) |
| User Equivalence: Trained and experienced healthcare professionals | Healthcare professionals completely familiar with use of the device (Same as Predicate) |
| Mechanism of Action Equivalence: Electronic control system designed to reciprocate a cannula in lipoplasty applications. | Electronic control system designed to reciprocate a cannula in lipoplasty applications. (Same as Predicate) |
| Electrical Safety Compliance: Meet IEC 60601-1 standards | Complies with IEC 60601-1:2005 and IEC60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Electromagnetic Compatibility (EMC) Compliance: Meet IEC 60601-1-2 standards | Complies with IEC 60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Biocompatibility: Intended use compatible materials | Considered biocompatible per ISO 10993-1 |
| Software Verification and Validation: Per IEC 62304/FDA Software Guidance | Verification and validation per IEC 62304/FDA Software Guidance |
| System Functionality - Stroke Rate/RPM Display Accuracy: Accurate display of speed. | Stroke Rate/RPM Display Calibration Validation: Pass |
| System Functionality - Stroke Distance Validation: Cannula reciprocation within specified range. | Stroke Distance Validation: Pass (2.90 mm +/- 0.3mm) (Similar to Predicate 2.8mm ±0.4mm) |
| System Functionality - Dynamic and Static Load Performance: Ability to perform under expected loads. | Dynamic and Static Load Validation: Pass |
| System Functionality - Surface Temperature during Operation: Patient contacting surface temperature within safe limits. | <41°C (Same as Predicate) |
| Cleaning, Disinfection, and Sterilization (CDS): Ability to be cleaned, disinfected, and sterilized to produce a sterile reusable handpiece and cable. | Cleaning/Disinfection: Mild non-abrasive cleaner wipe down in IFU (Similar to predicate's validated wipe down) Sterilization: Autoclavable by end user, steam sterilization (Same as Predicate) Demonstrates process produces a reusable sterile handpiece and cable with a SAL of 10-6 |
| Performance - Speed Range: Within operative range for liposuction. | 3000 - 5000 strokes/min (Different from Predicate's 4000-5000 strokes/min, but deemed not to affect safety/effectiveness as it replaces manual motions) |
| Performance - Duty Cycle: Ability for continuous operation. | Continuous (Different from Predicate's 2 hours continuous use/2 hours rest, but non-clinical testing demonstrates capability) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of an AI test set. Performance was demonstrated through non-clinical engineering tests of the device prototypes, material testing, and comparative analysis to a predicate device.
- Data Provenance: The data arises from in-house engineering testing, bench testing, and laboratory studies conducted by the manufacturer, Black & Black Surgical, Inc. This is inherent to hardware device approval processes. No patient data (retrospective or prospective) was used for performance validation as no clinical study was conducted. The country of origin of the data is implicitly the USA, where the company is based and the testing would likely have occurred or been commissioned.
3. Number of Experts Used and Qualifications for Ground Truth and 4. Adjudication Method:
- Not applicable. This device is not an AI/software product requiring expert ground truth or adjudication for image interpretation or diagnosis. The "ground truth" for this device's performance is objective measurements from engineering tests (e.g., motor speed, temperature, dimensions, electrical safety compliance) and comparison to established predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Not applicable. MRMC studies are specific to evaluating AI in diagnostic imaging where human readers interpret cases with and without AI assistance. This device is a surgical instrument.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its "performance" is its mechanical and electrical function.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's approval is based on engineering specifications, compliance with recognized electrical and safety standards (e.g., IEC 60601-1, ISO 10993-1), and documented performance of a legally marketed predicate device. It relies on objective physical measurements and adherence to established regulatory and engineering principles.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are iterative, informed by design inputs and testing, rather than a data-driven training paradigm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set or ground truth in the AI sense for this device. The design and validation are based on engineering principles, material science, and safety standards.
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