(132 days)
ferroFIBRE™ Stainless Steel Suture with Crimp is intended for use in soft tissue approximation and for use in abdominal wound closure. hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair
The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.
The provided FDA 510(k) summary for the PONTIS ferroFIBRE™ Stainless Steel Suture with Crimp describes a medical device, not a software algorithm or AI model. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
However, I can extract information related to the device's non-clinical testing, which serves a similar purpose of demonstrating safety and effectiveness compared to acceptance criteria for a physical device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Study for PONTIS ferroFIBRE™ Stainless Steel Suture with Crimp
This submission is for a medical device (stainless steel suture with a crimp), not an AI algorithm. Therefore, "acceptance criteria" and "device performance" are typically assessed through physical and mechanical testing rather than AI-specific metrics like AUC, sensitivity, or specificity. The "study" refers to non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: | Verification and Validation Testing includes: |
| - Withstand anticipated forces without failure (knot/crimp integrity) | - Knot failure force tested |
| - Maintain integrity under repetitive stress (cyclic loading) | - Crimp failure force tested |
| - Cyclic loading tested | |
| Biocompatibility: | - All biocompatibility testing performed under predicate submissions K101126 and K081060 remains applicable, indicating materials are safe for intended use. (This implies the new device meets the same biocompatibility standards as the predicates). |
| Sterility: | - Device is sterile, sterilized by ethylene oxide. (This implies it meets sterility acceptance criteria, although specific standards are not listed in the summary). |
| Functional Equivalence: | - Non-clinical tests demonstrate the proposed device is safe, effective, and performs as well as the predicate devices, thereby demonstrating substantial equivalence. (This is the overarching "performance" claim, inferring that the new device meets relevant performance standards as established by the predicates and demonstrated through the mechanical tests performed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "verification and validation testing" including "knot failure force, crimp failure force and cyclic loading." However, the number of samples used for these tests is not provided.
- Data Provenance: N/A for clinical data, as this is a non-clinical device submission. The tests are laboratory-based mechanical and biological evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- N/A. This information is for AI algorithms. For a physical device, testing is conducted according to established engineering and material science standards. The "ground truth" for device performance is typically defined by the test protocols themselves, often referencing ISO or ASTM standards, and evaluated by qualified engineers or lab personnel.
4. Adjudication Method for the Test Set
- N/A. This information is for AI algorithms, often referring to expert review of ambiguous cases. Device testing involves objective measurement and analysis against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
- N/A. This is a physical medical device, not an AI system. MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device. "Standalone performance" in this context refers to the device's mechanical and material properties as assessed in laboratory tests, which were performed.
7. The Type of Ground Truth Used
- Defined by Test Protocols and Predicate Device Performance: The "ground truth" for this device is effectively established by accepted mechanical engineering principles, material science standards, and the performance characteristics of the predicate devices. The tests (knot failure force, crimp failure force, cyclic loading) measure objective physical properties against expected or established benchmarks derived from the predicate devices, which are already considered safe and effective. Biocompatibility "ground truth" is based on established biological safety standards.
8. The Sample Size for the Training Set
- N/A. This information is for AI algorithms. There is no "training set" for this physical device in the AI sense. Device design and development might involve iterative testing of prototypes, but this is distinct from AI training.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no AI "training set," this question is not applicable. The design and validation of physical devices rely on engineering specifications, material properties, and performance data from similar, previously cleared devices.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.