(164 days)
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is an all-inside meniscal repair device. Each device includes two non-absorbable polymer implants, pre-tied with #2-0 non-absorbable suture and pre-loaded into a needle delivery system. The FAST-FIX 360 Meniscal Repair System is provided sterile for single use only.
The provided text describes the FAST-FIX 360 Meniscal Repair System, a suture retention device. However, it does not contain information about acceptance criteria, device performance metrics, a study design with test sets, training sets, expert involvement, or any statistical analysis typically associated with evaluating AI/ML models.
The submission is for a traditional 510(k) medical device that relies on demonstrating substantial equivalence to predicate devices based on design, intended use, fundamental scientific technology, and performance testing for mechanical properties.
Therefore, I cannot fulfill your request for specific details like sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies, as these concepts are not applicable to the information provided in the given texts.
Here's a summary of what is available related to performance, based on the provided text, and an explanation of why other aspects of your request cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|
| Substantially equivalent fixation properties to predicate devices | "Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices." |
Explanation: The documentation indicates that the device's performance was evaluated through "Cyclic load and ultimate tensile strength performance testing." The acceptance criterion, implicitly, was to demonstrate "substantial equivalence" to predicate devices (Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N18331)) in these mechanical characteristics. The specific numerical values for these tests or the quantitative thresholds for acceptance are not detailed in the provided text.
Regarding the other aspects of your request:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is not an AI/ML diagnostic or measurement tool. The "testing" referred to is mechanical engineering testing of physical properties, not a clinical study involving patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no mention of "experts" establish a "ground truth" in the context of diagnostic interpretation for this physical device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human interpretation or adjudication.
- 5. 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. This device is not an AI system, and therefore no MRMC study to compare human readers with and without AI assistance was performed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm; it is a physical surgical device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device is its physical performance parameters (e.g., tensile strength, cyclic load capacity) as measured in a lab.
- 8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML model for this device.
- 9. How the ground truth for the training set was established: Not applicable. See above.
§ 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.