(103 days)
The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.
The SmartGraft™ 30 system is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
- · Neurosurgery,
- · Gastrointestinal Surgery,
- · Urological Surgery,
- · Plastic and Reconstructive Surgery,
- · General Surgery,
- · Orthopedic Surgery,
- · Gynecological Surgery,
- · Thoracic Surgery,
- · Laparoscopic Surgery,
- · Arthroscopic Surgery
The SmartGraft™ 30 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.
Thislooks like a 510(k) summary for a medical device called the SmartGraft™ 30 System. The FDA has determined the device to be substantially equivalent to previously marketed devices. The document highlights the device's intended use in processing autologous adipose tissue and its technological characteristics.
The summary describes bench testing conducted to support the claim of substantial equivalence. However, it does not contain the detailed acceptance criteria or the specific study results in the format requested, particularly regarding statistical performance, sample sizes for training/test sets, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for the tables and specific details about acceptance criteria, reported performance, sample sizes, and ground truth establishment from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance metrics.
What the document does provide concerning testing:
- Bench Testing: Two non-clinical studies were performed on the SmartGraft™ 30 system.
- Study 1: Usability and Operation: Evaluated the system's usability according to Instructions for Use and its ability to produce concentrated adipose tissue from lipoaspirate.
- Study 2: Nucleated Cell Viability: Investigated the viability of nucleated cells in concentrated adipose tissue produced by the SmartGraft™ 30 system compared to unprocessed adipose tissue.
- Result of Viability Study: The results indicated that the SmartGraft™ 30 system "does not adversely impact viability of the adipose tissue." It concludes that the "Impact of the SmartGraft™ 30 system on cell viability is then substantially equivalent to that of predicate devices."
- Ground Truth for Bench Testing: For the usability and operation study, the ground truth was likely based on successful operation according to the Instructions for Use and the production of concentrated adipose tissue. For the cell viability study, the ground truth was "unprocessed adipose tissue" for comparison.
- No information is provided regarding:
- Specific quantitative acceptance criteria (e.g., "X% accuracy," "Y cells/mL viable").
- Specific reported device performance in numerical terms.
- Sample sizes used for these tests.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (as this is a physical device, not an AI algorithm).
- Training set sample size or how its ground truth was established.
§ 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.