(29 days)
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.
This document is a 510(k) summary for a medical device called "Force Fiber® Suture - Black." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study where specific performance criteria are measured against acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, I can extract the general acceptance criteria and what is reported about the device's performance based on the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Details of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surgical Suture Requirements (USP) | Meets all surgical suture requirements established by the USP for non-absorbable surgical sutures, specifically for: |
- Suture diameter
- Tensile strength
- Needle attachment | "Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter."
"Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003." |
| Material Biocompatibility (ISO 10993-1:2018) | Evaluation through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. This implies meeting the safety requirements for medical devices in contact with the body. | "All materials used in the fabrication of the Force Fiber Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." |
| MRI Safety | "MR Safe" designation, meaning it poses no known hazards in MR environments. | "Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments." |
| Substantial Equivalence | No differences in technological characteristics and performance characteristics compared to predicate devices, and the difference (addition of black dye) does not raise new questions of safety or efficacy, making it as safe and effective as currently marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) pathway. | "Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices. The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye... This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices." |
Information Not Available in the Document:
Because this document is a 510(k) summary demonstrating substantial equivalence for a surgical suture, not a clinical study report for an AI/imaging device, the following information is not provided:
- Sample size used for the test set and the data provenance: Not applicable in this context. The testing mentioned refers to material properties and biocompatibility, not performance against a specific "test set" of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI algorithms (e.g., diagnostic accuracy) is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" would be established by validated testing methods and specifications (e.g., USP standards), not expert consensus on medical images or outcomes.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a medical device (surgical suture) and demonstrates its compliance with established regulatory standards (USP, ISO) and substantial equivalence to existing predicate devices. It does not involve AI or imaging diagnostics, and therefore, many of the requested data points related to those types of studies are not relevant or present.
§ 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.