(152 days)
The ARIX Foot System (2.3/2.8) 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 fusion, corrective osteotomies, and the treatment of fractures.
The ARIX Foot System (2.3/2.8) is rigid fixation consisting of plates and screws in various confiqurations, shapes and sizes. The ARIX Foot System (2.3/2.8) 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, which are widely used for surgical implants with well-known biocompatibility. 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 & self-drilling screws are provided with diameter 2.0 mm to 2.8 mm and lengths from 6 mm to 46 mm.
The provided document is a 510(k) premarket notification for a medical device called the "ARIX Foot System (2.3/2.8)". This notification focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and bench testing, rather than reporting on the performance of an AI-powered diagnostic device or a study involving human readers.
Therefore, many of the requested categories for AI/diagnostic device performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment methods, are not applicable to this document. The document explicitly states: "No clinical studies were considered necessary and performed."
However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical testing performed.
Here's the breakdown, focusing on the information available:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical values or ranges. Instead, it states that the device complies with recognized standards for metallic bone plates and screws. The reported device performance is that the "results of this testing indicate that the ARIX Foot System (2.3/2.8) is equivalent to predicate device."
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates) | Complies with the standard. |
| ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws) | Complies with the standard. |
| Specific Tests Performed (Comparison to Predicate Device) | Result (Indicating Equivalence to Predicate) |
| Plate: | |
| Dimension Test | Equivalent to predicate device. |
| 4-Point Bending Test | Equivalent to predicate device. |
| 4-Point Fatigue Test | Equivalent to predicate device. |
| Screw: | |
| Dimension Test | Equivalent to predicate device. |
| Driving Torque Test | Equivalent to predicate device. |
| Torsion Test | Equivalent to predicate device. |
| Axial Pullout Test | Equivalent to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: The document does not specify the exact number of plates or screws tested for each non-clinical test. It generally refers to "bench tests" being conducted.
- Data provenance: The tests were conducted by Jeil Medical Corporation, located in Seoul, Korea. The data is prospective in the sense that these were specific tests performed for this submission, not analysis of existing 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. The "ground truth" for mechanical testing is based on engineered specifications and industry standards (ASTM standards), not human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for interpreting subjective assessments or diagnoses, not for objective mechanical tests.
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, an MRMC comparative effectiveness study was not done. This device is a metallic bone fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by the established mechanical properties required by the ASTM standards (ASTM F382 and ASTM F543) and the observed performance of the predicate devices. It is a technical ground truth based on engineering specifications and material science, not a medical "ground truth" for diagnosis.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned above.
§ 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.