(42 days)
Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Force Fiber OrthoTape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
The provided document is a 510(k) premarket notification for the Teleflex Force Fiber® OrthoTape™ Suture. It establishes substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses an AI/ML-based device, human readers, or a ground truth involving pathology or outcomes data. Therefore, many of the requested sections about AI/ML device performance and clinical study details cannot be answered based on the provided text.
However, I can extract information related to the device's performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (USP Requirements) | Reported Device Performance |
|---|---|---|
| Tensile Strength | USP requirements for #2 suture | Meets USP tensile strength requirements for #2 suture |
| Needle Attachment | USP requirements for #2 suture | Meets USP needle attachment requirements for #2 suture |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the test set (number of sutures or needles tested) for tensile strength and needle attachment. The testing was conducted in accordance with USP (United States Pharmacopeia) requirements, implying these are standard in vitro mechanical tests rather than clinical studies with patient data. Therefore, there is no country of origin for "data" in the context of patient data, nor is it retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for tensile strength and needle attachment is based on objective, standardized physical measurements against USP specifications, not expert consensus or clinical interpretation.
4. Adjudication method for the test set
Not applicable. The "test set" refers to physical samples of the suture undergoing mechanical testing against defined specifications. There is no human adjudication involved in these objective measurements.
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 a surgical suture, not an AI/ML-based diagnostic or assistive device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is based on objective physical and mechanical specifications outlined in the United States Pharmacopeia (USP) for non-absorbable surgical sutures, specifically for tensile strength and needle attachment. Additionally, biological qualification safety tests (AAMI ANSI ISO 10993-1: 2009/(R) 2013) were conducted on the materials.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment in that context.
§ 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.