(188 days)
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixation device intended to be permanently implanted. The implant is contoured with a tapered proximal end and contoured bend on the distal end. The implant has a 3-hole design and is 1.74 inches in length. The implant is single-use and may be available in sterile and non-sterile versions.
The Arthrex Minimally Invasive Ankle Fusion Plate is a bone fixation device intended for permanent implantation to fix bone fractures and fusions in the foot and ankle, to be used with Arthrex Low Profile Screws. The device is made of Titanium, has a 3-hole design, and is 1.74 inches in length.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Standard/Method | Device Performance | Conclusion |
|---|---|---|---|
| Static Bending Strength | ASTM F382-17 | Statistically equivalent to predicate device (K141735) | Met |
| Fatigue Bending Strength | ASTM F382-17 | Statistically equivalent to predicate device (K141735) | Met |
| MRI Safety (Force, Torque, Image Artifact) | FDA Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment | Testing conducted for force, torque, and image artifact. Specific values not reported in this summary, but the implication is that it meets safety guidelines. | Met |
| Bacterial Endotoxins Test (BET) | ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 | Meets pyrogen limit specifications | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document for each specific test. However, the document refers to "testing conducted" generally.
- Data Provenance: Not explicitly stated. The studies are laboratory-based performance tests evaluating the physical and biological properties of the device, rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The studies conducted are mechanical and material property tests against established engineering and biological standards (ASTM F382-17, FDA Guidance for MRI Safety, ANSI/AAMI ST72, etc.), not studies relying on expert interpretation of medical data. Therefore, there is no "ground truth" in the clinical sense established by medical experts for these tests. The "ground truth" is defined by the objective performance criteria outlined in the standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where multiple readers might interpret data to establish a consensus ground truth. The studies performed here are objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
No. An MRMC comparative effectiveness study is not discussed. This device is a bone fixation plate, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This information is not applicable as the device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted (static bending, fatigue bending, MRI safety, bacterial endotoxins) is based on established engineering and biological standards and specifications. For instance, the mechanical tests are compared against the performance of a predicate device cleared under K141735, implying that the predicate's performance against ASTM F382-17 served as the benchmark ("ground truth") for equivalence. The Bacterial Endotoxins Test has specific pyrogen limit specifications as its "ground truth."
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
§ 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.