(28 days)
Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
The Smith & Nephew™ ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed The online white ultra hight (UHMW) Polyethylene or white UHMW Polyethylene or emer with blue monofilament polypropylenc. ULTRABRAID suture is provided braided and undyed. ULTRABRAID sutures are USP except for diameter.
This is a 510(k) premarket notification for a surgical suture. This type of submission does not typically include detailed studies proving performance against acceptance criteria in the same way a diagnostic device or a more complex medical device would. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested categories for a study proving device meeting acceptance criteria will not be applicable.
Here's an attempt to answer based on the provided document, addressing the structure of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) for a surgical suture, the "acceptance criteria" are not usually explicit numerical performance targets like sensitivity/specificity for a diagnostic. Instead, they relate to demonstrating equivalence in design, materials, and function to a legally marketed predicate device.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Characteristics of ULTRABRAID™ Suture) |
|---|---|
| Design: Substantially similar design to predicate devices. | ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed of ultra high molecular weight (UHMW) Polyethylene or UHMW Polyethylene mixed with blue monofilament polypropylene. It is provided braided and undyed. It only differs from predicate devices in suture tipping to stiffen the suture ends. |
| Materials: Use of equivalent materials. | Composed of UHMW Polyethylene, which is a common material for nonabsorbable surgical sutures. |
| Function/Intended Use: Performs similarly to predicate devices for the same intended use. | Indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries, which is a standard indication for nonabsorbable sutures. ULTRABRAID sutures are USP (United States Pharmacopeia) except for diameter. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The submission asserts that the device is substantially equivalent, implying no new safety or effectiveness concerns. |
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 510(k) is based on a demonstration of substantial equivalence to predicate devices, not on a clinical or performance study with a "test set" in the context of diagnostic or complex device evaluation. The data provenance would be the characteristics of the device itself and its comparison to the predicate, likely based on engineering specifications and material properties, rather than patient data.
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. Ground truth as typically defined for studies (e.g., pathology for diagnostic imaging) is not part of a substantial equivalence review for a surgical suture.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" and thus no adjudication method in the context of clinical or diagnostic performance evaluation.
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. An MRMC study is not relevant for a surgical suture 510(k) submission. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices (Teleflex Medical, Force Fiber™ and Teleflex Medical, Force Fiber™ Blue Co-Braid Polyethylene Nonabsorbable Surgical Suture). The ULTRABRAID™ Suture demonstrates that it is substantially equivalent to these devices. This equivalence is often established through:
- Comparison of raw materials and manufacturing processes.
- Mechanical testing (e.g., tensile strength, knot security) to meet recognized standards (like USP) or match predicate device performance.
- Biocompatibility testing.
8. The sample size for the training set
Not applicable. No "training set" in the context of a statistical model or algorithm for a surgical suture.
9. How the ground truth for the training set was established
Not applicable. No "training set" or explicit ground truth established for it in this 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.