(186 days)
The SyntrFuge™ System is a sterile medical device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system.
The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal, urological surgery, general surgery, gynecological surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired.
Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
The SyntrFuge System is a sterile single use disposable medical device, comprised of three AdipoSets. Each AdipoSet is comprised of two AdipoChambers and one AdipoChip, two AdipoChambers attach to the AdipoChip by luer connectors.
The SyntrFuge™ System concentrates lipoaspirate, following a syringe vacuum liposuction method.
The SyntrFuge System is utilized in medical procedures where reinjection of adipose tissue into the same individual during the same surgical procedure is needed.
This document is a 510(k) Pre-market Notification for the SyntrFuge System, a medical device used for processing autologous adipose tissue. The information provided outlines the system's design, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic AI device.
Therefore, many of the requested elements for an AI device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, effect size for human readers) are not applicable to this type of device and submission.
However, based on the provided text, I can infer and extract the relevant information for the acceptance criteria and the type of "study" (which is more accurately described as "performance testing" and "comparison") that proves the device meets those criteria, specifically concerning the Nucleated Cell Viability.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance
The core performance metric mentioned for the device's function is centered around the viability of the concentrated adipose tissue.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2018 standards (non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, no systemic toxicity effects). | "Test results demonstrated that the SyntrFuge System is non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic and has no systemic toxicity effects." (Implies it met this criterion) |
| Product Specification Requirements | Meets established product specification requirements. | "The SyntrFuge™ System has undergone verification testing to ensure it meets product specification requirements. Verification testing consisted of the following: SyntrFuge System Design Verification Testing, Cleaning Validation, Cell Viability, Distribution Simulation and Packaging Integrity Testing, Usability Testing, Sterilization Validation and Shelf-Life Testing. All testing met specifications." (Overall confirmation) |
| Nucleated Cell Viability | Comparable to the predicate device (AdiPrep™ Adipose Transfer System). | SyntrFuge™ System: Mean = 87.8% |
| AdiPrep™ Adipose (Predicate): Mean = 83.5% | ||
| (Demonstrates a higher mean viability than the predicate, satisfying comparability or superiority) | ||
| Intended Use Capability | Functions as intended (harvesting, concentrating, transferring autologous adipose tissue). | "Bench test results allowed us to conclude that the SyntrFuge System meets its intended use." |
Additional Information Not Applicable to an AI Device (as requested, but noting their irrelevance here):
- Sample size used for the test set and the data provenance: Not specified for "cell viability" or other performance tests, as this is a mechanical device rather than an AI model. This is physical product testing, not a data-driven study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for cell viability would be established through laboratory assays, not expert interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to laboratory performance testing of a physical device.
- 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: Not applicable, as this is not an AI device assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Cell Viability," the ground truth would be established through laboratory-based cell counting and viability assays (e.g., trypan blue exclusion, flow cytometry). For other performance tests, it would be engineering specifications and validated test methods.
- The sample size for the training set: Not applicable, as this is not an AI device requiring a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device requiring a training set or ground truth in that context.
§ 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.