(204 days)
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
The Arthrex Low Profile Screws are headed and self-tapping screws manufactured from Titanium. They are available as fully and solid. The screw family ranges from 4.5 mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mm increments). The Arthrex Low Profile Screws are sold as sterile, single-use and non-sterile single-use.
This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws," a medical device intended for internal bone fixation. It does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/algorithmic device is not present in the provided text. The document focuses on the substantial equivalence of a physical medical device (screws) to a predicate device based on design, materials, and mechanical/safety testing.
Here's an attempt to answer the relevant questions based on the provided text, and highlighting what's not present:
1. A table of acceptance criteria and the reported device performance
Based on the "Performance Testing" section, the acceptance criteria relate to mechanical strength (driving torque, failure torque/insertion), MRI safety (force, torque, image artifact), and pyrogenicity. The exact numerical acceptance criteria are not specified in this summary, only that testing was "conducted in accordance with FDA guidance" and "demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength | "Arthrex performed driving torque and failure torque/insertion testing to evaluate the potential risk of decrease in mechanical strength." (Specific values and acceptance thresholds not provided) |
| MRI Safety | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." (Specific test results and acceptance outcomes not provided beyond adherence to guidance) |
| Pyrogenicity (Bacterial Endotoxins) | "The testing conducted demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications." (Specific limit and actual test result not provided) |
2. Sample size used for the test set and the data provenance
For the physical device testing (mechanical, MRI, biological), the sample sizes are not explicitly stated.
The data provenance is from Arthrex Inc. as part of this 510(k) submission. It's a pre-market submission, implying the data was generated to support the clearance, not necessarily from a large-scale clinical trial. The testing appears to be primarily lab-based and engineering verification rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a physical medical device, not an AI/algorithmic device requiring expert ground truth in the context of diagnostic/image interpretation. The "ground truth" here would be the physical properties and safety profiles verified through engineering and biocompatibility testing.
4. Adjudication method for the test set
This is not applicable for the type of testing described (mechanical, MRI safety, pyrogenicity for a physical orthopedic screw).
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. This document is for a physical orthopedic screw, not an AI/algorithmic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical orthopedic screw, not an AI/algorithmic device.
7. The type of ground truth used
For the described device, the "ground truth" is established through:
- Engineering specifications and standards: For mechanical properties (torque, strength).
- FDA Guidance Documents: For MRI safety testing protocols and acceptable limits.
- Pharmacopoeia/Standards (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14): For bacterial endotoxin levels.
8. The sample size for the training set
This is not applicable. There is no machine learning "training set" described for this physical device. The device itself is manufactured; it does not learn from data.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.