(197 days)
Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".
Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
The provided document is a 510(k) summary for the Demetech Absorbable Surgical Gut Suture (Plain and Chromic), demonstrating substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), expert involvement, and ground truth establishment is not applicable in this context.
However, I can extract the relevant information from the document to address the aspects that are present:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" here refers to meeting the performance requirements defined by the United States Pharmacopeia (USP) for absorbable surgical sutures, specifically USP 23 and the current edition USP 24. The reported device performance is that Demetech's suture "meets or exceeds" these requirements.
| Comparison Item (Acceptance Criteria) | Reported Device Performance (Demetech) |
|---|---|
| Finished suture material meets or exceeds performance requirements for "Absorbable Surgical Suture" as defined in USP 23 and USP 24. | Same (Meets or exceeds) |
| Finished suture material meets performance requirements for "Diameter" in USP 23 and USP 24. | Same (Meets) |
| Finished suture material meets or exceeds performance requirements for "Tensile Strength" in USP 23 and USP 24. | Same (Meets or exceeds) |
| Finished suture material meets or exceeds performance requirements for "Needle Attachment" in USP 23 and USP 24. | Same (Meets or exceeds) |
| Finished suture material meets performance requirements for "Finish suture Length Requirement" (95% of stated label length) in USP 23 and USP 24. | Same (Meets) |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data in the context of AI/ML. The performance testing is likely conducted on batches of manufactured sutures. The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is established by standardized physical tests, not expert consensus.
4. Adjudication method for the test set: Not applicable.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The ground truth used for evaluating the Demetech suture is standardized physical tests against the requirements of the United States Pharmacopeia (USP 23 and USP 24). This includes:
- General performance requirements for "Absorbable Surgical Suture"
- Specific requirements for "Diameter" ()
- Specific requirements for "Tensile Strength" ()
- Specific requirements for "Needle Attachment" ()
- Specific requirements for "Finish suture Length Requirement" (95% of stated label length)
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established: Not applicable.
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.