(233 days)
The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.
The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge
The KTA Adipose Treatment Kit is a medical device intended for autologous fat grafting procedures. The provided text describes the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" alongside specific performance metrics in a pass/fail format for each criterion. Instead, it lists the types of performance tests conducted and generally states that "All testing met their predetermined acceptance criteria."
However, based on the "Performance Data" and "Performance Testing" sections, we can infer the categories of acceptance criteria and the generalized reported performance:
| Category of Performance Testing | Implied Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Shipping Validation | Device integrity maintained after shipping simulations. | Met predetermined acceptance criteria. |
| Real Time and Accelerated Aging (Shelf-life) | Device components remain functional and sterile over stated shelf-life. | Met predetermined acceptance criteria. |
| Usability Testing | Device is easy and intuitive to use for its intended purpose. | Met predetermined acceptance criteria. |
| Connections Compatibility (connective forces and connection seal strength) | Connections are secure and maintain integrity under use (e.g., pressure). | Met predetermined acceptance criteria. |
| Maximum Pressure and Vacuum | Device components withstand specified pressure and vacuum without failure. | Met predetermined acceptance criteria. |
| Dimensional Analysis | Device components meet specified dimensions and tolerances. | Met predetermined acceptance criteria. |
| Resistance to Corrosion | Metallic components show no significant corrosion. | Met predetermined acceptance criteria. |
| Assembly Testing | Device components assemble correctly and function as intended. | Met predetermined acceptance criteria. |
| Biocompatibility Testing | Materials are non-cytotoxic, non-sensitizing, and non-irritating. | No cytotoxic potential, no delayed sensitization, irritation response met requirements (non-irritant). |
| Cell Viability Testing | The fat processing method maintains acceptable cell viability. | Met predetermined acceptance criteria. |
| Side Testing (Catheters/Introducers - Cannulas) | Cannulas withstand specified air pressure (3.2 bars). | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the sample sizes used for each individual performance test (e.g., how many cannulas were tested for pressure resistance, how many kits for usability). It refers generally to "bench testing."
- Data Provenance: The studies were non-clinical bench tests performed in vitro "in accordance with ISO/IEC standards and/or internal procedures / European standards." There is no mention of country of origin for the data other than the manufacturer being Stemcis S.A.S. based in France. These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable to the provided information. The studies described are non-clinical bench tests (e.g., material testing, mechanical testing) and not human reader studies or studies requiring expert clinical judgment to establish "ground truth." The "ground truth" for these tests is based on objective measurements against engineering and biological standards (e.g., ISO 10993 for biocompatibility, specified pressure limits for cannulas).
4. Adjudication Method for the Test Set:
- This question is not applicable as the studies are non-clinical bench tests and do not involve human adjudication of results in the traditional sense of clinical studies. Performance is measured against objective, predetermined technical specifications and standards.
5. 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:
- This question is not applicable. The KTA Adipose Treatment Kit is a physical medical device (kit for fat grafting), not an AI algorithm or an imaging device requiring interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. As stated above, the KTA Adipose Treatment Kit is a physical medical device, not an algorithm. Its performance is evaluated through bench testing of its components and overall function, not through standalone algorithm performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- For the non-clinical performance tests, the "ground truth" is based on:
- International Standards: e.g., ISO 10993-1 for biocompatibility.
- Internal Procedures/European Standards: for various mechanical and functional tests.
- Predetermined Acceptance Criteria: specific numerical or qualitative targets defined for each test (e.g., 3.2 bars air pressure resistance for cannulas, specific cell viability percentages).
- Objective Measurements: Results are compared against these established standards and criteria.
8. The Sample Size for the Training Set:
- This question is not applicable. The device is not an AI model or algorithm that requires a "training set." The tests performed are to validate the physical device's performance against established safety and efficacy standards.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 8.
§ 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.