(36 days)
The Polyglycolic Acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
DEXON® Violet is a braided synthetic absorbable surgical suture composed of homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone and is indicated for use as an absorbable suture in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. The DEXON® Violet Polyglycolic Acid Suture is an addition to the DEXON® family of Polyglycolic Acid Sutures and is sterile, inert, noncollagenous, nonantigenic and nonpyrogenic. DEXON Violet Polyglycolic Acid Sutures are available in various lengths, diameters and quantities with and without surgical needles. The DEXON® Violet Polyglycolic Acid Suture elicits a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of the polyglycolic Acid sutures occur by means of hydrolysis, where the polymer degrades to glycolic acid and is subsequently absorbed and metabolized by the body.
The provided text describes the 510(k) summary for the DEXON® Violet Polyglycolic Acid Suture, a surgical suture. However, it does not provide detailed information about specific acceptance criteria or an analytical study with numerical performance metrics for the device itself. The summary focuses on regulatory approval based on substantial equivalence to predicate devices and general safety testing.
Therefore, many of the requested sections regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted directly from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that a "battery of tests were performed in accordance to, and satisfied USP guidelines." While specific numerical acceptance criteria and performance results for each test are not provided, the types of tests conducted are listed.
| Acceptance Criteria (General Category) | Reported Device Performance (Satisfied) |
|---|---|
| Cytotoxicity | USP guidelines |
| Pyrogenicity | USP guidelines |
| Hemolysis | USP guidelines |
| Sensitization | USP guidelines |
| Mutagenicity | USP guidelines |
| Acute Systemic Toxicity | USP guidelines |
| Intracutaneous | USP guidelines |
| Intramuscular Implant | USP guidelines |
| Mammalian Mutagenicity | USP guidelines |
| 6-Month Ambient Storage Stability | USP guidelines |
| In-Vivo Strength Retention | USP guidelines |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the listed tests (e.g., cytotoxicity, pyrogenicity, in-vivo strength retention). It also does not provide information about the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are standard biocompatibility and material property tests, which typically rely on established laboratory protocols rather than expert consensus on ground truth in a clinical diagnostic sense.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where multiple human readers or observers assess cases. The tests described are laboratory-based and follow standardized procedures.
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
An MRMC study was not done. The device is a surgical suture, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical suture, not an algorithm. The "standalone" performance refers to the device's inherent material properties and biological interactions as evaluated by the listed tests.
7. The type of ground truth used
The "ground truth" for the tests performed (cytotoxicity, pyrogenicity, strength retention, etc.) would be established by the validated and standardized methods and acceptance limits defined by USP guidelines and other relevant material science and biological testing standards. For example, for cytotoxicity, the ground truth would be determined by whether the material causes a certain level of cellular damage in a standardized assay, compared to established criteria. For in-vivo strength retention, the ground truth would be the measured tensile strength over time compared to expected degradation profiles.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device (suture) and not an AI or machine learning model.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI model, there is no ground truth established for it.
§ 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.