(54 days)
Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.
Dekna-lok™ is Deknatel® Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture supplied with two integral acetal polymer buttressing components designed to spread the pressure of the suture across tissue.
This document is a 510(k) summary for the Dekna-lok™ Polyglycolytic Acid Surgical Suture. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific device performance metrics in a quantitative table, or an elaborate study description with the requested details beyond general statements about testing for materials and design.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document mentions that the device was evaluated through "recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 'Biological Evaluation of Medical Devices'." It also states that "Verification and Validation testing was performed according to the risk analysis."
- Reported Device Performance: The document concludes, "The design and materials were found to be acceptable for the intended use."
However, specific quantitative acceptance criteria (e.g., minimum tensile strength, degradation rates) and corresponding quantitative performance results for the Dekna-lok™ device are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The summary only mentions "Verification and Validation testing," implying internal testing by the manufacturer (Teleflex Medical).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not specified. This type of information (expert review for ground truth) is typically relevant for diagnostic or AI-driven devices, not a surgical suture which is evaluated based on material standards and physical/biological properties.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. As mentioned above, this is generally for interpretation-based studies.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned. This type of study is typically for evaluating the effectiveness of diagnostic tools, often imaging-based, with human readers involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a surgical suture, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for a surgical suture would be established through material property testing (e.g., tensile strength, knot security, degradation profile) against established standards (USP, ISO) and biological compatibility testing. The document refers to "USP 28:2005 Absorbable Surgical Sutures" and "ISO 10993 Part 1 'Biological Evaluation of Medical Devices'" as the standards used for evaluation.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device does not involve a "training set."
Summary of Study Information Provided in the Document:
The study described is a set of verification and validation (V&V) tests to demonstrate that the Dekna-lok™ suture's materials and design comply with relevant consensus standards and internal risk analysis requirements for its intended use.
- Scope of Testing: Materials used in fabrication and biological qualification safety tests.
- Standards Referenced: USP 28:2005 Absorbable Surgical Sutures and ISO 10993 Part 1 "Biological Evaluation of Medical Devices".
- Conclusion: "The design and materials were found to be acceptable for the intended use."
- Primary Study Goal: To establish substantial equivalence to a legally marketed predicate device (Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture, K992088) with respect to functionality, design, intended use, and performance characteristics.
In essence, the document serves as a regulatory submission demonstrating compliance with established standards for a medical device rather than a detailed scientific study report with quantitative performance data.
§ 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.