(28 days)
Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.
The Trelon® sutures are a polyamide (Nylon) multifilament suture that is available in common sizes and lengths and is available with or without pre-attached needles.
The provided text describes Trelon® Polyamide Sutures and their substantial equivalence to a predicate device, Dafilon® sutures. However, it does not contain detailed information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
Here's a breakdown of what is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| USP Requirements | The Trelon® sutures meet all USP requirements. |
Missing Information: The document does not specify which USP requirements were assessed (e.g., tensile strength, knot security, degradation profile, sterility, etc.) nor does it provide the quantitative performance data against those requirements. It only states that the device "meets all USP requirements."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not mention a specific "test set" or provide details on the sample size used for performance evaluation, nor does it specify data provenance (country, retrospective/prospective). The assessment appears to be based on compliance with USP standards, which are general specifications.
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)
Missing Information: Not applicable as there's no mention of a ground truth established by experts for a specific test set. The performance assessment relies on meeting general USP standards, not on expert evaluation against a particular dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Not applicable. There is no mention of a test set or an adjudication process.
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
Missing Information: Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: The "ground truth" equivalent here is the set of USP requirements for polyamide sutures. The device's performance is gauged against these established industry standards, not against clinical outcomes, pathology, or expert consensus on a particular dataset.
8. The sample size for the training set
Missing Information: Not applicable. This refers to a medical device (suture), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Missing Information: Not applicable. Similar to point 8, this refers to a medical device, not an algorithm.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.