(75 days)
The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.
The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The plates are available in long and short versions ranging from 50 mm to 115 mm in length. The plates are designed for the surgeon to cut to a desired length as needed. The Arthrex Mesh Plates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile and are single use.
The document describes the acceptance criteria and supporting studies for the Arthrex Mesh Plates, a medical device, not an AI/ML product. Therefore, several points in your request related to AI/ML devices (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.
Here's a breakdown of the available information regarding the acceptance criteria and studies for the Arthrex Mesh Plates:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Mechanical Performance (Tensile & Cyclic Testing) | Demonstrates that the Arthrex Mesh Plates perform statistically equivalent to the predicate device cleared under K143702. The ultimate tensile strength, stiffness, and cyclic fatigue of the proposed device are substantially equivalent to that of the predicate device for the desired indications. |
| MRI Safety (Force, Torque, Image Artifacts, Heating) | Conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213. (Implies satisfactory performance for MR Conditional labeling). |
| Bacterial Endotoxins Test (BET) | Performed utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, and Material Characterization testing conducted in accordance with ISO 10993-1:2018. (Implies satisfactory biocompatibility). |
| Sterilization & Shelf-Life | Assessment of physical product attributes (design, size, materials, manufacturing conditions, packaging) determined that the Arthrex Mesh Plates do not introduce additional risks or concerns regarding sterilization and shelf-life. (Implies acceptable sterilization and shelf-life). |
| Substantial Equivalence | The Arthrex Mesh Plates are substantially equivalent to the predicate devices K17057 and K143702. Basic design features, intended use, fundamental scientific technology, materials, sterility, packaging, and shelf-life are identical or have minor differences that do not raise different questions of safety or effectiveness. Supported by mechanical testing and technological comparison. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This information is typically relevant for AI/ML device studies. This submission pertains to a physical medical device (bone fixation plates). The mechanical and other tests would have specific sample sizes as per relevant ASTM/ISO standards, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert review, is typically relevant for AI/ML devices where human expert judgment is used to label data. For a physical device, performance is evaluated against engineering specifications and regulatory standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/ML performance evaluation based on expert consensus.
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
- Not Applicable. MRMC studies are specific to AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance without human intervention, which is not relevant for a physical implantable device.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by engineering standards, regulatory guidelines (e.g., FDA guidance for MR safety, ISO 10993 for biocompatibility), and direct mechanical testing against predicate device performance. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device might be. The goal is to demonstrate equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. "Training set" is a concept specific to AI/ML model development.
9. How the ground truth for the training set was established
- Not Applicable. This is specific to AI/ML model development.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.