(257 days)
The Vortech™ Adipose Transfer System (VATS) is used in medical procedures involving the harvesting and transferring of autologous fat tissue. The VATS System is used for concentrating fat harvested with a legally marketed lipoplasty system. The VATS System is intended for use in the following surgical specialties when the concentration of adipose tissue is desired.
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
The VATS System includes a disposable fat concentrator, reusable portable tabletop base unit, and single-use piston syringes.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Percent volume reduction substantially equivalent to predicate device (Viafill™ System) | Test results show the VATS System is substantially equivalent to the Viafill™ System. |
| Percent cell viability substantially equivalent to predicate device (Viafill™ System) | Test results show the VATS System is substantially equivalent to the Viafill™ System. |
| Functional within intended use | Results indicated both devices (VATS and predicate) were functional within their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing was performed" and "Test results for both percent volume reduction and percent cell viability show...". However, the specific number of tests or samples used for these comparisons is not provided.
- Data Provenance: The testing was non-clinical laboratory testing. The country of origin is not specified, but the applicant (Biomet Biologics, Inc.) is based in Warsaw, IN, USA, suggesting the testing likely occurred in the US. It was prospective testing as it was conducted to demonstrate substantial equivalence for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for this device was established through direct comparison to a predicate device's performance characteristics (percent volume reduction and cell viability) in a laboratory setting, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was non-clinical laboratory testing comparing performance against a predicate device, an adjudication method for a test set (like 2+1 or 3+1) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." The testing was non-clinical and focused on device performance parameters rather than human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, in a sense, the non-clinical testing represents a standalone evaluation of the device's performance in terms of its ability to concentrate fat and maintain cell viability, implicitly "without human-in-the-loop" once the device is operating. However, this is not an "algorithm" in the typical sense of AI, but rather a physical system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by the performance characteristics of the legally marketed predicate device (Cytori AFT System, K072587 and Lipose Fat Transfer System, K081848, specifically the Viafill™ System from Lipose Corp. for direct comparison). The ground truth was the established performance of these previously cleared devices in terms of percent volume reduction and percent cell viability.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical system for fat concentration, not an AI/ML algorithm that requires a training set. The term "training set" doesn't apply in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.