(231 days)
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.
The provided document is a 510(k) summary for a surgical suture device (Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Suture). It does not describe an AI medical device or a study involving acceptance criteria and device performance in the context of AI.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not available in the provided text.
Here's what can be extracted based on the nature of the device (a traditional medical device, not AI):
1. A table of acceptance criteria and the reported device performance
The document states: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." It also mentions conformance with:
- USP 30 (United States Pharmacopoeia)
- ISO 9001 and ISO 13485 (Quality Management Systems)
- FDA Guidance for Surgical Suture 510(k)
However, specific numerical acceptance criteria (e.g., tensile strength, degradation rates) and their corresponding reported device performance values are not detailed in the provided summary. The summary broadly states that the device "conforms" to these standards and performed "as intended and as claimed," which implies meeting the (unspecified in this document) acceptance criteria within those standards.
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "Invivo/in vitro testing."
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for studies involving human interpretation or subjective assessment, typically for diagnostic or screening AI devices. For a surgical suture, performance is evaluated against physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for subjective assessments in diagnostic studies.
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
- No. This is not an AI device. The document explicitly states: "No clinical trials were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device, the "ground truth" would be established by objective measurements against established physical, chemical, and biological standards (e.g., tensile strength, degradation profile, biocompatibility as per USP, ISO, and FDA guidance). The document refers to "Invivo/in vitro testing."
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that requires a training set.
Summary relevant to the provided text:
The submission highlights that the device (Atramat® PGC25 Surgical Sutures) is marketed as "substantially equivalent" to predicate devices (Monocryl* (poliglecaprone 25) Suture). This equivalence is based on:
- Technological Characteristics: Similar composition (copolymer of glycolide and epsilon-caprolactone), sterile, monofilament, synthetic, absorbable.
- Performance Standards: Conformance to USP 30, ISO 9001, ISO 13485, and FDA Guidance for Surgical Suture 510(k).
- Testing: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." No clinical trials were conducted.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.