(114 days)
The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 meniscal repair systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB, AND FAST FIX 360 are indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB AND FAST-FIX 360 devices are intended to be used for anchoring the . allograft to the meniscal rim during allograft transplant procedures.
The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are all-inside meniscal repair device includes two polymer implants, pretied with non-absorbable suture pre-loaded into a stainless steel needle delivery system with an adjustable length depth penetration limiter. Product variants are offered with either a straight, curved or reverse curved delivery needle, and are provided sterile for single use only.
Here's a breakdown of the acceptance criteria and study information for the ULTRA FAST-FIX Meniscal Repair System, ULTRA FAST-FIX AB Meniscal Repair System, and FAST-FIX 360 Meniscal Repair System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in fixation properties to predicate | "Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent to legally marketed predicate device." |
| No new issues of safety and efficacy compared to predicate | "The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy." |
| Substantial equivalence in intended use | "The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in intended use... to the following legally marketed devices..." |
| Substantial equivalence in fundamental scientific technology | "The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent...in Fundamental Scientific Technology to the following legally marketed devices..." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify numerical sample sizes for the performance testing (cyclic load and ultimate tensile strength). It only refers to "performance testing."
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The device is a physical medical device (suture retention system), and the performance evaluation is based on mechanical testing (cyclic load, ultimate tensile strength), not on expert assessment of images or clinical data for diagnostic purposes.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC study was not done and is not applicable. This device is not an AI/imaging device requiring human reader analysis. The study focused on the physical performance of the device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done, in the context of mechanical testing. The device's fixation properties were tested independently to demonstrate equivalence to predicate devices, without human intervention in the device's operational performance during testing.
7. The Type of Ground Truth Used
The ground truth used was the mechanical performance characteristics (cyclic load and ultimate tensile strength) of legally marketed predicate devices. The new devices were compared against these established benchmarks.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device and study. This is a medical device submission based on showing substantial equivalence through mechanical performance, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as 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.