(235 days)
The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavice hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and fragments, replantation, malunions, and for non-load bearing stabilization and reduction of long bone fragments.
Small fragment, mini fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius and mini fragment plates may be used in adolescents (12-2 years of age). Plating may be used in patients with osteopenic bone.
The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with locking and non-locking screws. ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ANTHEM® Fracture System:
This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for AI/ML-driven medical devices analyzing diagnostic images or other complex data. Instead, this document describes a traditional orthopedic implant (bone plate and screws). Therefore, the "acceptance criteria" and "study" described here pertain to the mechanical and material performance of the physical device, not an algorithm's diagnostic accuracy or performance.
Many of your requested points (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to a submission for a physical, non-AI orthopedic implant like the ANTHEM® Fracture System.
However, I can extract the relevant information that is present in the document.
Acceptance Criteria and Study for the ANTHEM® Fracture System
The acceptance criteria for the ANTHEM® Fracture System are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing and material composition.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets recognized ASTM standards for bone fixation devices and is comparable to predicate devices. | Evaluated in accordance with ASTM F382 (for plates), F543 (for fasteners), and F2193 (for screws). Performance data (including static and dynamic bending, insertion/removal, axial pullout, static torsion, and cantilever bend) demonstrate substantial equivalence to the predicate device. |
| Material Composition | Constructed from biocompatible materials commonly used in orthopedic implants, specified by ASTM international standards. | Manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139. |
| Design & Function | Similar design, function, and size range to predicate devices. | Subject ANTHEM® implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes. |
| Sterilization & Biocompatibility | Pre-established sterilization and biocompatibility profiles meeting regulatory requirements. | Previous sterilization and biocompatibility testing applies to the subject devices; no new testing required for this submission. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a "test set" from patient data. The "sample size" here refers to the number of individual implants or test specimens subjected to mechanical testing. This information is typically detailed in the full test reports, which are not included in this 510(k) summary.
- Data Provenance: Not applicable as this is not patient- or algorithm-derived data. The data originates from in vitro mechanical testing performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for mechanical testing is established by engineering principles and adherence to ASTM standards, not by clinical expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance studies, not for mechanical device testing.
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
- Not applicable. This device is a physical surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For mechanical testing, the "ground truth" is defined by the established and validated ASTM (American Society for Testing and Materials) standards. The device's performance metrics (e.g., bending strength, pullout force) are compared against the requirements and typical performance of legally marketed predicate devices under these standardized tests.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of the Study:
The study performed for the ANTHEM® Fracture System was a mechanical performance study and engineering analysis. It involved:
- Mechanical Testing: static and dynamic bending, insertion/removal, axial pullout, static torsion, and cantilever bend tests. These tests were conducted in accordance with specific ASTM international standards (F382, F543, F2193).
- Engineering Analysis: This analysis compared the design, materials, and expected performance of the ANTHEM® Fracture System to its predicate devices to demonstrate substantial equivalence, rather than direct human clinical outcomes comparisons.
The goal of these studies was to demonstrate that the ANTHEM® Fracture System is substantially equivalent to previously cleared predicate devices in terms of safety and effectiveness for its intended use, based on established engineering and material science principles, rather than clinical trial data.
§ 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.