(84 days)
Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Coated Monoderm™(Polyglactone 72) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by coating Monoderm™ suture with a mixture of caprolactone, glycolide and glycolic acid.
The provided text describes a 510(k) summary for a surgical suture device (Monoderm™), which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the kind of details requested.
Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth for training set) are not applicable or not provided in this type of regulatory submission.
However, I can extract information related to performance data and equivalency claims as much as possible.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not presented in a table format with explicit acceptance criteria values. Instead, the document states general conformance to standards and describes performance relative to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to USP 27 standards for surgical sutures. | "Physical testing was performed on Monoderm™Coated, Synthetic, Absorbable sutures to USP 27, including Suture Diameter, Suture Needle Attachment, Tensile Strength." (Specificity of "conformance" implies meeting the USP requirements, but no specific values are given.) |
| Biocompatibility (ISO 10993) | "Animal testing was performed for conformance to ISO 10993 for biocompatibility..." (Specificity of "conformance" implies meeting the ISO requirements, but no specific results are given.) |
| Rates of tensile strength and mass loss (in vivo / implant studies) | "...and implant studies to demonstrate rates of tensile strength and mass loss." (No specific rates or numerical performance values are provided, only that studies were done to demonstrate them.) |
| Dissolution / Absorption Time | "Coated Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days." |
| (Comparison to predicates: Caprosyn: 56 days; Monocryl: 91-119 days) | |
| Material composition and characteristics | "Surgical Specialties Corporation's Monoderm™Synthetic, absorbable suture is made from a mixture of Glycolide/e-caprolactone. The material has been well characterized through absorption studies and biocompatibility studies. The product is similar to the predicate devices, Monocryl and Caprosyn, in that they are both made from a polymer blend of synthetic absorbable materials." (This is more of a characteristic description than a performance metric with an acceptance criterion.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document mentions "Physical testing" and "Animal testing" but does not give the number of samples or animals used.
- Data Provenance: Not specified. The studies were performed by Surgical Specialties Corporation. The country of origin of the data is not mentioned. Whether studies were retrospective or prospective is also not stated, but typically, these types of tests for product clearance are prospective.
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)
- Not applicable. This is not the type of device or study that typically involves expert ground truth for a test set in the way an AI diagnostic device would. Performance is assessed against physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this physical and biological product testing.
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 device is a surgical suture, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical testing (diameter, needle attachment, tensile strength), the "ground truth" would be established by standardized measurement techniques defined by USP 27.
- For biocompatibility and implant studies, the "ground truth" would be established by histopathological examination and assessment of biological responses according to ISO 10993 guidelines, and measurement of physical properties (tensile strength, mass loss) over time.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product developed with training sets.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML product developed with training sets.
§ 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.