(295 days)
The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- · Sternotomy indications including the "rewiring" of osteotomized sternums.
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
- · Repair of long bone fractures due to trauma or reconstruction.
The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.
The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.
However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:
| Performance Aspect (Implicit Acceptance Criterion) | Reported Device Performance |
|---|---|
| Fatigue Strength | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Tensile Force | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Creep | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Knot Strength | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Wear Testing with Particle Analysis | Demonstrated no statistical significant differences between the proposed Arthrex FiberTape Cerclage and the cleared DSM Biomedical DPR Cable. |
| Bacterial Endotoxins Test (Pyrogenicity) | Performed in accordance with USP and demonstrated that the device meets pyrogen limit specifications. (This implies it passed the limits set by USP ). |
| Biocompatibility | Not explicitly detailed in this section, but is generally required for medical devices. The document implies it's covered by substantial equivalence to predicates using similar materials. |
| Material Composition | Braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials, identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).
- Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).
4. Adjudication Method for the Test Set
This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This is not applicable. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As stated in point 5, this is not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.
- For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
- For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP .
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.