(291 days)
'cottony'TM II Polyester Suture Tape is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.
Deknatel Polyester Suture Tapes are nonabsorbable, sterile surgical sutures composed of Poly(ethylene terephthalate). They are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Deknatel Polyester suture tapes are provided braided, undyed (white) and dyed
Deknatel Pledgets are precut pieces from a sheet of polytetrafluoroethylene (PTFE) fabric used to spread the load the suture against host tissue.
The document provided is a 510(k) summary for the 'cottony' II Polyester Suture Tape and Pledgets. It states that the device is substantially equivalent to a predicate device (K021019) and preamendment devices. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.
Instead, the document primarily focuses on establishing substantial equivalence through:
- Indications for Use: The 'cottony' II Tape is for general soft tissue approximation and/or ligation (including cardiovascular, ophthalmic, orthopedic, and neurological procedures), and the Pledgets are for suture reinforcement and buttressing. These indications are aligned with the predicate device.
- Technological Characteristics: A comparison was performed which demonstrated equivalence in performance characteristics.
- Materials: All patient-contacting materials comply with ISO10993-1.
- Performance Data (Non-clinical testing): Testing was performed in accordance with ISO11607-1:2006 (packaging) and USP 36-NF 31 (sutures-needle attachment), and (tensile strength) to demonstrate substantial equivalence to the predicate devices.
Therefore, I cannot provide the specific details requested in the acceptance criteria table and the subsequent points (2-9) because this type of information (e.g., sample size, data provenance, number of experts for ground truth, MRMC study results, standalone performance, training set details) is typically found in clinical studies or detailed performance verification reports, which are not part of this 510(k) summary. The 510(k) process relies on demonstrating equivalence to a legally marketed predicate, rather than establishing de novo performance metrics with acceptance criteria like those described for AI/ML devices.
Summary of available information related to performance criteria (though not in the requested format):
| Acceptance Criteria Category | Reported Device Performance (or Equivalence Claim) |
|---|---|
| Tensile Strength | Non-clinical testing performed in accordance with USP 36-NF 31 to demonstrate substantial equivalence to predicate devices. (Specific numerical values for acceptance criteria and reported strength are not provided in this document). |
| Needle Attachment | Non-clinical testing performed in accordance with USP 36-NF 31 to demonstrate substantial equivalence to predicate devices. (Specific numerical values for acceptance criteria and reported attachment strength are not provided in this document). |
| Packaging Integrity | Non-clinical testing performed in accordance with ISO11607-1:2006 to ensure packaging for terminally sterilized medical devices meets requirements for materials, sterile barrier systems, and packaging systems. (Specific numerical values for acceptance criteria and reported results are not provided in this document). |
| Biocompatibility | All patient contacting materials are in compliance with ISO10993-1. (Specific test results or acceptance criteria are not provided in this document). |
| Stability (Shelf-life) | A modification was made to add a stability claim of 5 years. (Specific test results or acceptance criteria are not provided in this document). |
| Indications for Use | The device is indicated for general soft tissue approximation and/or ligation (Tape) and suture reinforcement and buttressing (Pledgets), which are deemed substantially equivalent to the predicate device and preamendment devices. |
The following information cannot be extracted from the provided document as it does not describe a study involving algorithms, AI, or specific clinical performance metrics with detailed acceptance criteria of the type implied by the questions:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.