(181 days)
The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.
The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.
The provided text describes a medical device, the A.I.M. Knotless Meniscal Repair Device, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with diagnostic AI/imaging devices.
The document states: "Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading." This indicates performance testing was done, but the specific acceptance criteria (e.g., minimum pull-out strength in Newtons, number of cycles survived at a certain load) and the detailed results are not provided in the given text.
Therefore, I cannot fill out the requested table or answer most of the questions as the necessary data is absent from the provided text.
Here's what I can infer from the text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Not Given) | Reported Device Performance (General Statement) |
|---|---|---|
| Pull-out performance | Not Specified in document | Performs as well or better than the predicate device. |
| Cyclic loading | Not Specified in document | Performs as well or better than the predicate device. |
All other requested information regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, training set details, and ground truth establishment methods is not available in the provided document, as it focuses on a a physical medical device (suture retention device) and its substantial equivalence and not an AI or imaging diagnostic device. The 'study' mentioned is a bench test to compare mechanical properties with a predicate, not a clinical or AI performance study.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.