(78 days)
MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation
Two configurations of MaxBraid™ suture are included in this submission. The first consists of a polyester core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyester Plus Suture. The second type consists of a polyethylene core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyethylene Plus Suture. Both types are supplied in lengths of 38" with or without attached suturing needles. The suture is size 2 in keeping with currently recognized United States Pharmacopoeia (USP) standards. Both white and blue suture will be marketed. The suture is coated with silicone in order to ease passage through tissue. When desired, the MaxBraid™ Polyester Plus and Polyethylene Plus Suture may be used with a commercially available suture anchor.
The provided text is a 510(k) summary for the MaxBraid™ Suture, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with detailed performance metrics.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used (beyond general "USP standards")
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "Clinical Testing: None provided." This indicates that no clinical studies were performed, which would be the typical source for the detailed performance data requested.
Instead, the document states:
- Non-Clinical Testing: "Testing demonstrated that MaxBraid™ Suture met or exceeded the USP 24 standards for nonabsorbable sutures and are substantially equivalent to the predicate devices."
This means the acceptance criteria are adherence to USP 24 standards for nonabsorbable sutures, and the "study" demonstrating this involves non-clinical (i.e., bench or lab) testing. However, the specific metrics, their measured values, sample sizes, and detailed methodology of these non-clinical tests are not provided in this 510(k) summary.
§ 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.