(442 days)
Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is: -(0-CH2-CH2-O-CH2-CO-CH2-CO)n- Filbloc sutures are undyed or dyed with D&C Violet No. 2 (21CFR§ 74.3602). The device is designed with unidirectional or bidirectional barbs, or with unidirectional barbs and final block in PDO. The barbs and the block design allow for tissue approximation, without need to tie surgical knot. The device is available in various lengths and diameter sizes 2 through 4/0 with various needles attached at one end or to both ends.
The provided text describes the 510(k) premarket notification for the "Filbloc" absorbable polydioxanone surgical suture. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a novel AI/software device and proving its performance through a study of that nature.
Therefore, the information required to answer the prompt is not present in the provided text. The document outlines a regulatory submission for a physical medical device (surgical sutures), detailing its material, design, intended use, and comparison to existing predicate devices. It describes physical and biocompatibility testing, but not a study designed to meet specific acceptance criteria for a device's "performance" in the way an AI/software device would be evaluated (e.g., sensitivity, specificity, AUC).
Here's why the required information is missing:
- Acceptance Criteria & Reported Device Performance (Table): The document doesn't define quantitative performance metrics such as sensitivity, specificity, accuracy, or any thresholds related to diagnostic or analytical performance. It discusses tensile strength and absorption time in comparison to a predicate, but these are material properties, not software performance.
- Sample Size (Test Set) & Data Provenance: Not applicable in the context of an absorbable suture device. The "testing" refers to physical and biocompatibility tests on the suture material itself, not a dataset of medical images or patient records.
- Number of Experts & Qualifications: Not applicable. There's no interpretive task that would require expert adjudication of a test set.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is irrelevant for a surgical suture.
- Standalone Performance: While the "device" (suture) is a standalone physical product, the concept of "standalone performance" in the context of AI refers to the algorithm's performance without human intervention, which isn't relevant here.
- Type of Ground Truth: Not applicable in the AI/software sense. The "ground truth" for a suture would be its physical properties and biological absorption characteristics, confirmed through laboratory and animal testing.
- Sample Size (Training Set) & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/machine learning device.
In summary, the provided document is a 510(k) submission for a physical medical device (surgical sutures), outlining its characteristics and demonstrating substantial equivalence to a predicate device through physical and biocompatibility testing. It does not contain the type of information typically found in a study proving the acceptance criteria for an AI/software-based medical device.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.