(26 days)
The ARIX Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm. ARIX Foot System is provided as blue color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surgical instruments, such as quide pins, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and screw driver handle. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.
The provided text describes the regulatory clearance for the ARIX Foot System, a medical device for internal fixation, reconstruction, or arthrodesis of small bones. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm or diagnostic device.
The document specifically states under "Clinical Test Summary" that "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical (bench) testing and substantial equivalence to existing devices, not on a study with human subjects, AI assistance, or expert ground truth determination.
Therefore, most of your requested information regarding acceptance criteria for an AI/ML device and the study proving it are not applicable to this document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Non-Clinical): The device must comply with ASTM F382-99 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
- Reported Device Performance: The bench tests (tensile strength test, bending strength test per ASTM F382) indicated that the ARIX Foot System is "equivalent to predicate device" and "met all design specifications."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This was a non-clinical, bench testing study on the device itself, not a study involving a test set of data (e.g., medical images) from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for an AI/ML device is not relevant here as there's no AI component or human interpretation being evaluated. The "truth" in this context is adherence to engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. The document explicitly states "No clinical studies were considered necessary and performed." There is no mention of AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" equivalent in this non-clinical context would be the engineering specifications and ASTM standards (ASTM F382-99, ASTM F543-07). The device's performance was measured against these established standards.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned.
§ 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.