(28 days)
Quill™ Quadrahelix Knotless Tissue-Closure Device is indicated for soft tissue approximation excluding closure of the epidermis
The Quill™ Quadrahelix Knotless Tissue Closure Device is a non-absorbable isotactic polymer comprised of polypropylene per 21 CFR 878.5010. It is available sterile, undyed (beige) in suture and needle configurations in USP Size 3-0. Each suture has bi-directional quadrahelix barbs along the long axis of the suture monofilament. The Quill™ Quadrahelix Knotless Tissue Closure Device approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength | Conforms to defined product requirements |
| Wound Security Strength | Conforms to defined product requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "Non-clinical laboratory performance testing was conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described is "Non-clinical laboratory performance testing," which implies physical tests rather than expert-driven evaluation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study is non-clinical laboratory testing, not a human-reader-based assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study was non-clinical laboratory testing for physical properties of the suture.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device described. The device is a physical surgical suture, not a software algorithm. The "standalone" testing refers to the device's physical properties without human intervention during the test itself (e.g., pulling strength tests).
7. Type of Ground Truth Used
The ground truth used for this device would be engineering specifications and established standards for tensile strength and wound security for surgical sutures. For example, specific forces (e.g., in Newtons) that a suture of a certain size must withstand without breaking or losing its wound-holding capacity.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device.
Summary of the Study:
The study was a non-clinical laboratory performance testing focused on the physical properties of the Quill™ Quadrahelix Knotless Tissue-Closure Device. The key performance metrics assessed were tensile strength and wound security strength. The study concluded that the device conforms to defined product requirements for these metrics and is substantially equivalent to the predicate devices. The details regarding the specific methodologies, sample sizes, and quantitative results of these non-clinical tests are not included in the provided 510(k) summary. The "ground truth" was established by pre-defined engineering and manufacturing specifications for surgical sutures.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.