(93 days)
Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
Smith & Nephew ULTRATAPE is a non-absorbable, sterile, synthetic surgical suture composed of UHMW (Ultra High Molecular Weight) polyethylene, offered braided, in both blue and a co-braid of blue/ white. ULTRATAPE is flat in shape, and has a width of 2mm, meeting USP tensile strength requirement for size #2 surgical suture. ULTRATAPE does not comply with USP size classifications. When used with various anchoring implants in orthopedic procedures, it secures and holds the reattached tendon to bone.
Here's a summary of the acceptance criteria and study information for the Smith & Nephew ULTRATAPE surgical suture, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Knot Tensile Strength met according to USP standard for non-absorbable, #2 size surgical suture. | "Mechanical testing data for Knot Tensile Strength according to USP standard for nonabsorbable, #2 size surgical suture demonstrates the device has met the performance specifications" |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the mechanical testing. However, it indicates that the testing was conducted "in accordance with USP requirements," which would imply a scientifically sound and sufficient sample for demonstrating compliance.
- Sample size for test set: Not explicitly stated (implied by "in accordance with USP requirements").
- Data provenance: Not explicitly stated (likely laboratory testing conducted by the manufacturer as part of the 510(k) submission process).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of device and study presented. The study involves mechanical testing against a recognized standard (USP), not expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable. This was a mechanical test against a technical standard, not a study requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, an MRMC comparative effectiveness study was not done. This device is a surgical suture, and its performance is evaluated through mechanical testing, not by human readers interpreting images or data.
6. If a Standalone (algorithm only without human-in-the-loop) performance study was done:
Not applicable. This device is a physical medical device (suture), not an algorithm or AI system. Its performance is inherent to its physical properties, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this study was the USP standard for Knot Tensile Strength for non-absorbable, #2 size surgical suture. The device's performance was compared directly against this established technical specification.
8. The Sample Size for the Training Set:
Not applicable. There is no AI or machine learning component to this device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this 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.