(90 days)
DEXON® Rapid (DEXON "R") sutures are indicated for use in the surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
The Dexon® "R" Polyglycolic Acid Suture is an Absorbable Suture composed of a homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone. The polycaprolate coating system is inert, noncollagenous, nonantigenic and nonpyrogenic. The Dexon "R" sutures are sterile, inert, noncollagenous, nonantigenic and nonpyrogenic and are available in various colors.
The provided text describes a 510(k) submission for a surgical suture, not a device that relies on an algorithm or AI. Therefore, most of the questions regarding acceptance criteria and study design for an AI/algorithm-based device are not applicable to this document. The document focuses on the substantial equivalence of the suture to predicate devices and results from standard biocompatibility and strength retention tests.
Here's an attempt to answer the relevant questions based on the provided text, while explicitly stating when information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | These are standard tests for medical devices to ensure they are safe for use in the body. | |
| Cytoxicity (elution test) | Deemed acceptable | Passed standard cytotoxicity tests. |
| Systemic Injection | Deemed acceptable | Passed systemic injection tests. |
| Pyrogenicity | Deemed acceptable | Passed pyrogenicity tests. |
| Intracutaneous Injection | Deemed acceptable | Passed intracutaneous injection tests. |
| Physical Performance | These likely pertain to the mechanical integrity and absorption properties of the suture. | |
| Strength Retention | Deemed acceptable | Passed strength retention tests, implying it meets predefined mechanical performance over time. |
| Material Composition | Homopolymer of glycolic acid, coated with Polycaprolate (copolymer of glycolide and epsilon-caprolactone) | This is a description of the material, not a performance criterion per se, but it must match the predicate. |
| Sterility | Sterile | A fundamental requirement for surgical sutures. |
| Non-collagenous, Non-antigenic, Non-pyrogenic | Stated to be inert, non-collagenous, non-antigenic, non-pyrogenic | These are characteristics that contribute to biocompatibility and were likely confirmed through testing. |
| Intended Use | For use in surgical closure of skin and mucosa where short-term wound support is required and where rapid degradation is desirable. Not for ligation, ophthalmic, cardiovascular, or neural tissue. | This is the defined scope of safe and effective use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "a battery of tests were performed" but does not specify sample sizes for these tests, nor the data provenance (e.g., whether the tests were conducted in a specific country or were retrospective/prospective observations).
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)
This question is not applicable as the device is a surgical suture, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device would be established through laboratory testing and potentially in vivo animal or human studies (though no human study details are given here).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as above. Adjudication methods are typically used when subjective interpretations (e.g., image readings) are involved in establishing ground truth.
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
This question is not applicable as the device is a surgical suture, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance and safety would be established through:
- Laboratory testing: Measuring physical properties like strength retention, absorption rates, and material composition.
- Biocompatibility testing: In vitro (e.g., cytotoxicity) and in vivo (e.g., systemic injection, pyrogenicity, intracutaneous injection) tests to assess biological response.
- Comparison to predicate devices: The primary method for proving substantial equivalence, relying on the established safety and effectiveness of previously approved devices.
8. The sample size for the training set
This question is not applicable as the device is a surgical suture and does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 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.