(90 days)
The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, and malunions of fragments of long bones of the pelvis, the femur, the humerus, and the foot. The system is not intended for use in the spine.
The ARIX Cannulated Screw System consists of cannulated screws and corresponding washer. The thread diameters of cannulated screws are 6.5 and 7.3 mm. They are either fully or partially threaded. Screws and a washer are made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. All devices in the system are provided non-sterile.
The provided document, K233912, is a 510(k) Premarket Notification for the ARIX Cannulated Screw System. This document outlines the premarket review by the FDA for a medical device, specifically a bone fixation fastener, and not an AI/ML-driven diagnostic or prognostic device.
Therefore, the information typically requested in your prompt regarding AI/ML device studies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.
The document discusses bench tests for mechanical performance to demonstrate substantial equivalence to a predicate device. Here's what can be extracted from the document regarding its performance criteria and testing:
1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document as specific numerical thresholds, but implied as "better than the acceptance criteria" for mechanical tests. | ARIX Cannulated Screw System mechanical test results were "better than the acceptance criteria" according to ASTM F543. |
| Compliance with ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws. | The device complies with ASTM F543. Specific tests performed include: |
- Torsion Test
- Driving Torque Test
- Axial Pull-out Test |
2. Sample Size and Data Provenance:
- Sample Size: The document does not specify the sample size (number of screws) used for the mechanical bench tests.
- Data Provenance: Not applicable in terms of patient data. The tests were bench tests conducted on the physical device. The manufacturer is Jeil Medical Corporation in South Korea.
3. Number of Experts and Qualifications (for Ground Truth):
- Not applicable. Ground truth for mechanical performance is established through standardized engineering test methods (ASTM F543) and physical measurements, not human expert consensus.
4. Adjudication Method:
- Not applicable for mechanical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a physical medical device, not an AI/ML system requiring human reader performance evaluation. The document explicitly states: "No clinical studies were considered necessary and performed."
6. Standalone Performance:
- Not applicable. This refers to the performance of the physical device in bench tests, not an AI algorithm. The document states its performance was evaluated for each mechanical test according to ASTM F543.
7. Type of Ground Truth Used:
- Engineering Standards and Physical Measurements: For mechanical performance, the ground truth is based on the specifications and test methods outlined in ASTM F543. Measurements from the tests (e.g., torque, axial pull-out force) are compared against these established physical and material science standards.
8. Sample Size for Training Set:
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable.
In summary, the provided document relates to the FDA clearance of a conventional medical device based on mechanical bench testing and substantial equivalence to a predicate device, rather than the evaluation of an AI-powered diagnostic or prognostic tool. Therefore, many of the requested details about AI/ML study methodologies are not present in this type of FDA submission.
§ 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.