(24 days)
SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissue are used for repair.
SutureTape is a braided suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends and has a width of 1.3 mm. SutureTape is available in precut lengths in straight and loop configurations, and with or without needles. SutureTape is packaged sterile for single use. SutureTape meets USP standards for size 2 suture, except for an oversize in diameter. The SutureTape modifications as compared to the predicate device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a suture core and different braiding pattern of colored yarns. Additionally, SutureTape is braided flat similar to the cleared LabralTape (K122374) but has round suture tails similar to the cleared FiberTape (K032245).
The provided text is a 510(k) summary for a medical device called "SutureTape." It describes the device, its intended use, and performance data from various tests. However, it does not contain information about a study involving AI or human readers, or any other details related to AI performance criteria.
Therefore, many of your requested points cannot be answered from the provided document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Strength (straight pull, knot pull, needle pull) exceeds USP requirements for size 2 suture | Exceeds USP requirements for size 2 suture (based on diameter of suture ends spanning USP size 1 and 2 diameter ranges) |
| Pyrogen limit specifications (Bacterial endotoxin testing per EP 2.6.14/USP ) | Meets pyrogen limit specifications |
| Biocompatibility | Acceptable (due to similarities with predicate) |
| Shelf-life | Acceptable (due to similarities with predicate) |
2. Sample size used for the test set and the data provenance: Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI-assisted diagnostic device. The "ground truth" here refers to established standards (USP requirements, EP/USP standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: For mechanical properties, the ground truth is United States Pharmacopeia (USP) requirements for surgical sutures. For pyrogen testing, the ground truth is EP 2.6.14/USP standards. Biocompatibility and shelf-life are determined based on similarity to predicate devices.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
§ 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.