(75 days)
The FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal repairs, allograft transplant procedures, and anchoring the allograft to the meniscal rim during allograft transplant procedures.
FAST-FIX® FLEX is comprised of an implant-suture construct incorporating #2-0 nonabsorbable Ultra-high Molecular Weight Polyethylene (UHMWPE) suture having a pre-tied one-way sliding knot between two non-absorbable polyetheretheketone (PEEK) polymer implants. The suture-implant construct is preloaded into a needle delivery inserter. The needle delivery inserter is offered in two device configurations of curved and reverse curved, whose needle can be modified by the end user with a supplied Bend Tool. The Bend Tool is a sterile, single use optional non-measuring accessory intended to control the bend radius and limit the bend angle to ensure reliable deployment of implants after modification. A sterile, single use slotted cannula is also supplied with the system.
This document describes a 510(k) premarket notification for the "FAST-FIX FLEX Meniscal Repair System." This submission is for a surgical device, not an AI/software device. Therefore, many of the requested criteria (e.g., test set, ground truth for AI, MRMC studies) are not applicable.
However, I can extract the information relevant to the performance testing of this surgical device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a quantitative table of specific acceptance criteria values with corresponding measured device performance numbers. Instead, it states that the device "met performance specifications" and "met all acceptance criteria."
| Test Category | Acceptance Criteria (General Description) | Reported Device Performance (General Description) |
|---|---|---|
| Biocompatibility | Per ISO 10993-1:2018 requirements | All acceptance criteria were met; deemed biologically safe |
| Sterilization | Suitability for terminal sterilization under same conditions as predicate | Compared to predicate, demonstrated suitability. |
| Implant Repair Testing | Met performance specifications | Met performance specifications |
| Implant Bridge Strength | Met performance specifications | Met performance specifications |
| Tensile Strength through Cyclic Loading | Met performance specifications | Met performance specifications |
| Implant Failure Testing | Met performance specifications | Met performance specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (e.g., number of devices, number of tests) used for the performance testing. It mentions "nonclinical performance data" but does not detail the size of the test sets for each specific test.
Data Provenance: Not explicitly stated regarding geographical origin or retrospective/prospective nature. For non-clinical device testing, this typically refers to lab-based experimental data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a physical surgical device, and its performance is evaluated through material and mechanical testing, not by human experts establishing "ground truth" on images or clinical cases in the way AI models are evaluated.
4. Adjudication Method for the Test Set
Not applicable. See point 3. Testing involves objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. See point 3. MRMC studies are relevant for diagnostic AI/imaging devices, not surgical implants. The comparison is made against a predicate device based on technological characteristics and non-clinical performance data, not human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. See point 3.
7. The Type of Ground Truth Used
For this surgical device, the "ground truth" or "reference standard" is the predefined performance specification for each test (e.g., minimum tensile strength, specific sterilization parameters, biocompatibility standards). These are typically derived from engineering principles, relevant ISO standards (like ISO 10993-1:2018 for biocompatibility), and comparison to the predicate device's known performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.