(326 days)
The Smith & Nephew ULTRABRAID™ II Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
The Smith & Nephew ULTRABRAID II is a non-absorbable, sterile, synthetic surqical suture composed of either white UHMW polyethylene and/or blue UHMW polyethylene. The proposed suture is in a braided configuration and will be offered in sizes 2-0 through 2 meeting USP requirements except for slight variation in the diameter as described in the U.S.P Monogram for synthetic nonabsorbable surgical suture. ULTRABRAID II suture will be provided either pre-loaded onto suture anchors or sold separately, with or without attached needles. When used with various anchoring implants in orthopedic procedures, the suture secures and holds the re-attached tendon to the bone.
The provided text is a 510(k) summary for a medical device called the "Smith & Nephew ULTRABRAID™ II Suture." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove performance from scratch. Therefore, the information requested in the prompt, which typically relates to performance studies for novel devices or AI/software, is largely not applicable in this context.
Here's an breakdown of why specific points are not available and what information is present:
Context of the Document:
The 510(k) summary (K101377) for the Smith & Nephew ULTRABRAID™ II Suture is a premarket notification to the FDA. Its primary goal is to show that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device (Smith & Nephew ULTRABRAID suture, K041216). This means it does not typically involve establishing new acceptance criteria or conducting extensive clinical trials as one would for a novel device. Instead, the focus is on comparing against the known characteristics and performance of the predicate.
Information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission comparing to a predicate, new explicit "acceptance criteria" in the sense of performance thresholds for a novel device are not defined in the provided text. The criteria are implicitly met by demonstrating equivalence to the predicate's performance.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (ULTRABRAID II Suture) |
|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate in: |
| Knot Break Strength | Performed, results show substantial equivalence |
| Needle Attachment Strength | Performed, results show substantial equivalence |
| Diameter Properties | Performed, results show substantial equivalence |
| Biocompatibility | Meets biocompatibility requirements of ISO 10993-1 for Implant Device, Bone/Tissue contact, Permanent contact |
Note on "Acceptance Criteria": The document states: "The differences which include a minor change to braid configuration and a material change in the blue fiber from a polypropylene pigmented monofilament to blue polyethelene, do not raise new questions of safety or efficacy." This implies that the 'acceptance criteria' are met if these changes do not negatively impact safety or efficacy compared to the predicate, and existing standards (like USP for suture diameter, and ISO 10993-1 for biocompatibility) are met.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Non-clinical testing that included knot break strength, needle attachment strength, and diameter properties were performed". The exact number of samples tested for each of these physical properties is not disclosed in this summary.
- Data Provenance: The "test set" here refers to physical samples of the ULTRABRAID II Suture. The data would be generated from laboratory testing of these physical samples. The country of origin of the data is implicit as part of the Smith & Nephew company, based in Andover, MA, USA. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a physical medical device (suture), not an AI/software device requiring expert human review to establish ground truth for image interpretation or diagnosis. The "ground truth" for its performance is established through objective physical and chemical testing (tensile strength, diameter measurement, biocompatibility panels), not expert consensus.
4. Adjudication Method for Test Set
- Not Applicable. As above, this is for physical testing, not a clinical study involving human readers or evaluators requiring adjudication. The results would be objectively measured values, typically compared against specifications or predicate device data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is relevant for AI-powered diagnostic or screening tools where the algorithm assists human readers. The ULTRABRAID II Suture is a surgical implant, not a diagnostic tool, and therefore MRMC studies are not relevant.
6. Standalone Performance Study
- Yes, in the context of physical testing. The "non-clinical testing" (knot break strength, needle attachment strength, diameter properties, and biocompatibility) represents standalone performance evaluation of the ULTRABRAID II Suture itself. There is no "human-in-the-loop" concept here as it's a physical product being tested for its intrinsic properties.
7. Type of Ground Truth Used
- Physical/Chemical Properties and Standards: The ground truth for the device's performance is established through:
- Objective measurements: Knot break strength, needle attachment strength, and diameter properties are directly measured values.
- Compliance with standards: USP (United States Pharmacopeia) requirements for suture properties (with noted slight variation in diameter) and ISO 10993-1 for biocompatibility.
- Comparison to predicate device: The ultimate "truth" for this submission is that its performance on these metrics is substantially equivalent to the cleared predicate device (K041216).
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How Ground Truth for Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.