(20 days)
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.
The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.
This document is a 510(k) premarket notification for a surgical suture. It demonstrates substantial equivalence to a predicate device rather than providing a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information from the provided text.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Details (Not Applicable for this Submission Type)
Since this is a 510(k) submission for a surgical suture establishing substantial equivalence, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically applied to diagnostic AI algorithms (e.g., sensitivity, specificity thresholds) does not directly apply. Instead, the submission focuses on demonstrating that the new device (Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture) is as safe and effective as a legally marketed predicate device (Force Fiber Polyethylene Non-Absorbable Surgical Suture).
The evaluation is based on technological characteristics and their equivalence to the predicate, along with meeting general regulatory requirements (USP for suture sizes, general controls).
The document states: "The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness." This is the core "proof" of equivalence for this type of device, rather than a clinical performance study with statistical metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the context of diagnostic AI acceptance criteria. The "acceptance" for this device is based on demonstrating substantial equivalence to a predicate by meeting (or being equivalent to) its technological characteristics and regulatory standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (Equivalent to predicate) | Composed of ultra high molecular weight polyethylene (UHMWPE), same as predicate. |
| Sterility | Sterile (as required for surgical sutures). |
| Non-absorbability | Non-absorbable (same as predicate). |
| Intended Use (Equivalent to predicate) | To approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries (same as predicate). |
| Meeting USP Requirements (Except for size for oversized) | Available in sizes 2-0 through 2, meeting USP requirements except for oversized diameter. The dimensional change is stated not to adversely affect safety and effectiveness. This implies that other critical physical/mechanical properties are still within acceptable (USP-like) ranges. |
| Technological Characteristics (Equivalent to predicate) | Stated to be "the same as or equivalent to the predicate device." |
| Safety and Effectiveness (Not adversely affected by changes) | "The dimensional specification change does not adversely affect safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission does not involve a "test set" in the sense of a dataset for an algorithm. It's a review of device design and specifications against a predicate.
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. No expert ground truth establishment for a test set was performed or documented in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set was performed or documented.
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 diagnostic tool.
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 AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" relates to material properties, manufacturing specifications, and biological compatibility, which are assessed through standard engineering and biocompatibility testing, not through expert consensus on diagnostic images or pathology. The document doesn't detail specific testing.
8. The sample size for the training set
Not applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is involved.
In summary: The provided document is a 510(k) summary for a medical device (surgical suture). It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting a performance study against specific acceptance criteria for a diagnostic algorithm.
§ 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.