(90 days)
The Arthrex Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The proposed Arthrex Mini Fragment System consists of a series of plates and screws of varying lengths and thicknesses. Each plate provides locking screw fixation. The proposed screws are a family of locking and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold non-sterile and single-use.
The provided text describes a 510(k) premarket notification for the Arthrex Mini Fragment System. This document focuses on the mechanical and material performance of the device compared to a predicate device, rather than the performance of an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this submission.
The acceptance criteria and study proving the device meets them are based on bench testing (mechanical and MRI compatibility), demonstrating substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the available information relevant to your request, with an emphasis on why certain sections are not applicable in this context:
Acceptance Criteria and Device Performance (for a Mechanical Fixation System)
The "acceptance criteria" for the Arthrex Mini Fragment System are demonstrated by showing that its mechanical performance is statistically equivalent to the predicate device, and that it meets established MRI safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test and Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static 4-Point Bend (ASTM F382-17) | "demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412." |
| 4-Point Fatigue Bend (ASTM F382-17) | "demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412." | |
| Pull-out (ASTM F543-17) | "demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412." | |
| Failure Torque | "demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412." | |
| Insertion Torque (ASTM F543-17) | "demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412." | |
| MRI Compatibility | Magnetic Resonance (MR) Environment Testing (FDA Guidance, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) covering: | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance..." and "The Arthrex Mini Fragment System was evaluated for MR Conditional labeling..." implying successful completion. |
| - Magnetically Induced Displacement Force (ASTM F2052) | Specific numerical results not provided in the summary but indicated as acceptable. | |
| - MR Image Artifacts (ASTM F2119) | Specific numerical results not provided in the summary but indicated as acceptable. | |
| - Radio Frequency Induced Heating (ASTM F2182) | Specific numerical results not provided in the summary but indicated as acceptable. | |
| - Magnetically Induced Torque (ASTM F2213) | Specific numerical results not provided in the summary but indicated as acceptable. |
Information Not Applicable or Not Provided for a Mechanical Device:
- Sample size used for the test set and the data provenance: Not applicable. This refers to the number of physical test specimens used for bench testing, not a "test set" of patient data for AI/ML. The document does not specify the number of samples tested for each mechanical or MRI test, nor data provenance (as it's bench data, not clinical data).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established by engineering specifications, material science, and physical testing standards.
- Adjudication method for the test set: Not applicable. There is no human interpretation of a test set in this context.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for mechanical implants.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: For mechanical performance, the "ground truth" is defined by the established ASTM standards and the performance of the predicate device. For MRI compatibility, it is defined by the specific ASTM standards and FDA guidance. This is not "expert consensus, pathology, or outcomes data" in the typical sense of medical diagnostics.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable. Since there's no training set, there's no ground truth to establish for it.
§ 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.