(89 days)
Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Deknatel 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. Silk Suture is waxed, braided or twisted, and provided dyed (black) or undyed (natural white). Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
This document is a 510(k) premarket notification for a medical device called "Deknatel Silk Surgical Sutures." It is not a study describing a device's performance against acceptance criteria in the typical sense of a clinical or AI performance study. Instead, it's a regulatory document demonstrating substantial equivalence to a predicate device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, training set details, etc.) are not applicable here.
However, I can extract the information that is present to describe the "acceptance criteria" and "study" as best as possible within the context of a 510(k) submission for a surgical suture.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (surgical suture), "acceptance criteria" are generally based on meeting recognized standards, specifically the United States Pharmacopeia (USP) requirements. The "device performance" is reported as compliance with these standards.
| Acceptance Criteria (USP Standards) | Reported Device Performance |
|---|---|
| USP (United States Pharmacopeia) Nonabsorbable Sutures | Meets all requirements established by USP for Nonabsorbable Surgical Suture. |
| USP 36-NF 31 Sutures - Diameter | Non-clinical testing performed in accordance with this standard to verify mordant material change. |
| USP 36-NF 31 Sutures - Needle Attachment | Non-clinical testing performed in accordance with this standard to verify mordant material change. |
| USP 36-NF 31 Tensile Strength | Non-clinical testing performed in accordance with this standard to verify mordant material change. |
| Biocompatibility (ISO 10993-1, G95-1) - Cytotoxicity | Testing included (Biocompatibility evaluated in accordance with relevant standards). |
| Biocompatibility (ISO 10993-1, G95-1) - Sensitization | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Irritation | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Systemic toxicity | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Subchronic toxicity | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Genotoxicity | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Implantation | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Haemocompatibility | Testing included. |
| Biocompatibility (ISO 10993-1, G95-1) - Pyrogen testing | Testing included. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the "test set" in terms of physical units of sutures. The "test set" in this context refers to the samples of the Deknatel Silk Surgical Sutures that underwent non-clinical performance and biocompatibility testing. This kind of testing is typically performed internally by the manufacturer or by a contract lab.
- Sample Size: Not explicitly stated for each test, but standard statistical sampling is assumed for compliance testing.
- Data Provenance: The testing was "non-clinical" and likely conducted in a laboratory setting to demonstrate compliance with USP standards and biocompatibility guidelines. The country of origin of the data is not specified but would typically be from the manufacturer's or a certified testing lab's facilities. This is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to this type of device and regulatory submission. "Ground truth" in this context is established by the predefined specifications of the USP standards and ISO 10993 guidelines, which are universal and do not typically require expert consensus on a case-by-case basis during testing for these physical and biological properties. The "experts" would be the scientists, engineers, and toxicologists who designed and conducted the tests and interpreted the results against the established standards. Their qualifications would be expertise in materials science, biomechanics, analytical chemistry, toxicology, and regulatory compliance.
4. Adjudication method for the test set
Not applicable. Testing against USP and ISO standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication process by multiple experts in the way clinical studies or AI algorithm ground truth establishment might.
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 is a surgical suture, not an AI-powered diagnostic device or a system designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (suture), not an algorithm.
7. The type of ground truth used
The "ground truth" for this submission are the established international and national standards for surgical sutures and biocompatibility:
- United States Pharmacopeia (USP) requirements for Nonabsorbable Surgical Sutures (e.g., diameter, needle attachment, tensile strength).
- ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a physical device like a surgical suture. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.