(75 days)
The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DemeTECH Silk Nonabsorbable Suture:
This document is a 510(k) summary for a medical device regulatory submission, not a detailed scientific study publication. As such, it focuses on demonstrating substantial equivalence to a predicate device and compliance with established standards, rather than presenting a comprehensive research study with detailed methodology and extensive performance data common for novel high-risk devices.
Based on the provided information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent to predicate device: Grams Silk Nonabsorbable Suture (K003001) | Demonstrated as equivalent to the predicate device. |
| Meets United States Pharmacopeia (USP) 23 requirements for Nonabsorbable Surgical Sutures. | Meets USP 23 requirements for Nonabsorbable Surgical Sutures. |
| Meets United States Pharmacopeia (USP) 24 requirements for Nonabsorbable Surgical Sutures. | Meets USP 24 requirements for Nonabsorbable Surgical Sutures. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical trial or performance study. The evaluation appears to be based on physical and material properties testing to demonstrate compliance with USP standards and equivalence to the predicate device. No details about data provenance (e.g., country of origin, retrospective/prospective) are provided, as this type of information is typically associated with clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission relies on established standards (USP) and comparison to a legally marketed predicate device. There is no mention of "ground truth" derived from expert consensus in a clinical context for this type of device. The "experts" involved would be those performing the specified physical and chemical tests to USP standards and those reviewing the equivalence claims.
4. Adjudication Method
Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts assess cases to establish a consensus ground truth. This is not the type of study described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for imaging or diagnostic AI devices where human readers interpret data with and without AI assistance. This device is a surgical suture, and such a study is not applicable to its evaluation.
6. Standalone Performance Study
The statement "The DemeTECH Silk Nonabsorbable Suture has been demonstrated as both equivalent to the predicate device and meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures" indicates that standalone performance (i.e., the suture itself meeting defined metrics) was evaluated against the USP standards. This could be considered a form of standalone testing, though not in the context of an "algorithm only" as typical for AI. The "study" here refers to the testing conducted to show compliance with these material standards.
7. Type of Ground Truth Used
The "ground truth" used for this device is based on United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures and the specifications of the legally marketed predicate device (Grams Silk Nonabsorbable Suture). This means the device's physical, chemical, and performance characteristics were compared against established, standardized benchmarks.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning or AI models. This submission is for a physical medical device (suture) and does not involve AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI training set involved. The "ground truth" for the device's characteristics was established by the USP standards themselves, which define the required properties for surgical sutures, and by the characteristics of the predicate device.
§ 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.