(60 days)
SutraSilk nonabsorbable silk sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
SutraSilk silk suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.
This non-absorbable suture is composed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specifications.
The suture may be uncoated or have a silicone coating, a paraffin wax coating, or a natural gum coating (Virgin silk). The sutures come with needles attached.
Here's a breakdown of the requested information regarding the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test) | Standard Met | Reported Device Performance |
|---|---|---|
| Diameter | United States Pharmacopeia (U.S.P.) standards | Meets USP standards |
| Tensile Strength | United States Pharmacopeia (U.S.P.) standards | Meets USP standards |
| Suture-Needle Attachment Strength | United States Pharmacopeia (U.S.P.) standards | Meets USP standards |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size used for the tests. It only states "tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted".
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was 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 applicable as the study described is a performance test against established industry standards (USP), not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This study involves direct physical property measurements against predetermined standards, not subjective interpretations requiring adjudication.
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
- No. This is not an AI-powered diagnostic device, nor is it a study involving human readers or comparative effectiveness in that context. It's a performance study for a surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. It's a physical medical device (suture).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance tests was the United States Pharmacopeia (U.S.P.) standards for diameter, tensile strength, and suture-needle attachment.
8. The sample size for the training set
- Not applicable. This is a performance study for a physical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.