(280 days)
The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually packaged nonabsorbable Polyester surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes.
The DemeTECH Polyester Nonabsorbable Suture is a medical device and thus does not involve AI/ML performance.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by USP) | Reported Device Performance |
|---|---|
| Meets United States Pharmacopeia (USP) 23 requirements | Device demonstrated to meet USP 23 requirements |
| Meets United States Pharmacopeia (USP) 24 requirements | Device demonstrated to meet USP 24 requirements |
| Equivalent to legally marketed predicate device | Device demonstrated to be equivalent to predicate device |
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Sample size used for the test set and the data provenance: Not applicable. The study involved testing the physical properties of sutures against USP standards and comparing them to a predicate device, not analyzing patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by adherence to published United States Pharmacopeia (USP) standards, which are defined by scientific testing methodologies rather than expert consensus on individual cases.
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Adjudication method: Not applicable. The assessment was based on physical property testing against USP standards.
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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. This is a medical device for surgical procedures, not an AI/ML diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical suture, not an algorithm.
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The type of ground truth used: The ground truth used was based on established United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. This involves standardized physical and chemical testing methods to ensure quality and performance. Additionally, equivalence to a legally marketed predicate device (Grams Polyester Nonabsorbable Suture) served as a benchmark.
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The sample size for the training set: Not applicable. This is a medical device, not an AI/ML model that requires a training set. The study involves quality control testing for manufacturing standards.
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How the ground truth for the training set was established: Not applicable.
§ 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.