(68 days)
MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation.
Modified MONOCRYL sutures, undyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone.
The provided text is a 510(k) summary for a medical device (MONOCRYL suture, undyed) seeking substantial equivalence to a predicate device (MONOCRYL suture, dyed). This submission type focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way one might for a novel AI device.
Therefore, the requested information elements related to AI device performance studies (sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. The document describes a comparison between two physical medical devices where the key metric is breaking strength retention.
Here's the breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Breaking Strength Retention (BSR) Profile | Identical to the predicate device (MONOCRYL suture, dyed) |
Notes on Acceptance Criteria: The "acceptance criterion" here is implicitly that the BSR profile of the undyed suture must be the same as the predicate dyed suture, as this is how substantial equivalence is being claimed for this aspect.
2. Sample size used for the test set and the data provenance: Not applicable. This was non-clinical laboratory testing.
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 physical material properties is established through standardized laboratory testing, not expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Laboratory measurement of "Breaking Strength Retention profile after implantation."
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.
Summary of the Study:
The study was a nonclinical laboratory testing to compare the "breaking strength retention (BSR) profile after implantation" of the modified MONOCRYL suture, undyed, with its predicate device, MONOCRYL suture, dyed. The finding was that the BSR profile for both devices was identical. This equivalence in a key performance characteristic was a basis for concluding that the new device is substantially equivalent to the predicate device.
§ 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.