(18 days)
AESCULAP® Absorbable Surgical Gut Sutures and Softcar® Absorbable Surgical Gut Sutures are indicated for use in all types of gencral soft tissue approximation and/or ligation, including ophthalmic procedures, but not for use in cardiovascular or neural tissue.
The subject device is an absorbable, flexible suture thread, available in both plain and chromicized forms, which is supplied sterile. It is manufactured from the serosal connective tissue layer of bovine intestine or the submucosal layer of ovine intestine. It is indicated for general soft tissue approximation and/or ligation, including ophthalmic tissues, but not including cardiovascular or neural tissues. It is undyed, and is available with and without needles attached. In the Softcar® form, both plain and chromic sutures are treated with glycerol.
The provided text is a 510(k) summary for the AESCULAP® Absorbable Surgical Gut Suture. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed study in the manner of an AI/medical device performance evaluation.
Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) is not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights physical property testing to ensure compliance with U.S.P. standards and biosafety/implant studies to demonstrate equivalency to existing sutures.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance to USP XXIII) | Reported Device Performance |
|---|---|
| Sutures -- Diameter | Conforms in all respects to requirements of USP XXIII |
| Sutures -- Needle Attachment | Conforms in all respects to requirements of USP XXIII |
| Tensile Strength (Knot Pull, Straight Pull) | Physical properties substantially equivalent to predicates |
| Flexibility | Physical properties substantially equivalent to predicates |
| Knot Security | Physical properties substantially equivalent to predicates |
| Shelf Life Validation | Demonstrated substantial equivalence |
| Sterilization Validation | Demonstrated substantial equivalence |
| In vitro and in vivo biosafety (biocompatibility) | Demonstrated substantial equivalence |
| Implant studies (tensile strength and mass loss) in animals | Demonstrated substantial equivalence |
| Manufacturing process (materials and methods) | Equivalent to predicate devices |
| Packaging and labeling claims (indications, contraindications, warnings, cautions, precautions) | Same or equivalent to predicate devices |
Explanation: The acceptance criteria are essentially derived from the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII and equivalence to the predicate devices. The reported device performance is a general statement of compliance and substantial equivalence, without specific numerical results in this summary.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The document refers to "testing of physical properties" and "in vitro and in vivo biosafety studies" without detailing sample sizes for each.
- Data Provenance: The studies were non-clinical (in vitro, in vivo animal implant studies), with physical property testing likely conducted in laboratories. The country of origin for the data is not specified, but the submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (suture) submission focusing on physical properties and biocompatibility, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This type of adjudication method is relevant for studies involving human interpretation (e.g., medical imaging), which is not the case here.
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 study type is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used
The "ground truth" for this device is based on:
- USP XXIII Standards: These are established physical, chemical, and performance specifications for absorbable surgical sutures.
- Predicate Device Characteristics: Benchmarking against existing, legally marketed similar devices (Davis & Geck, Ethicon, U.S. Surgical Corporation) established the expected performance and safety profile.
- Animal Study Outcomes: In vivo studies in animals provided empirical data on tensile strength retention and mass loss, which were compared to expected performance based on predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
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.