(157 days)
The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.
The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.
The provided text is for a medical device (The OrthoPro Ankle Trauma System) that is a metallic bone fixation appliance. The acceptance criteria and the study performed for this type of device are primarily focused on non-clinical performance benchmarks, demonstrating substantial equivalence to predicate devices, rather than clinical performance measures or AI-driven diagnostic accuracy.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will largely pertain to biomechanical testing and comparison with legally marketed predicate devices, and not to a clinical study involving human readers, AI assistance, or diagnostic accuracy metrics typically seen in AI/ML medical devices.
Here's the breakdown based on the provided text, addressing the points where information is available or applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are typically defined by demonstrating substantial equivalence in performance to predicate devices through standardized biomechanical testing. The performance is reported as meeting or exceeding the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plate Biomechanical Performance: Demonstrated substantial equivalence to predicate devices under ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates). | The OrthoPro plate was found to be substantially equivalent to the predicate device. In most cases, device function performed with superiority. |
| Screw Biomechanical Performance: Demonstrated substantial equivalence to predicate devices under ASTM F543-07 (Standard Specification and Test Metallic Bone Screws). | The screws from the Ankle Trauma System were found to be substantially equivalent to the predicate device. |
| Materials: Use of Titanium alloy (Ti 6Al 4V ELI) per ASTM F136. | The device uses Titanium alloy (Ti 6Al 4V ELI) per ASTM F136, matching or being substantially equivalent to predicate device materials (Titanium and/or stainless steel). |
| Indications for Use: Comparable to predicate devices. | The Indications for Use are substantially equivalent to the predicate devices. |
| Design and Function: Comparable to predicate devices. | The design and function are substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly mentions tests conducted on "the worse case plate" and "the screws" from the Ankle Trauma System. This implies a limited number of physical samples for mechanical testing, not a large test set of clinical data from patients. The provenance of these physical samples would be the manufacturing facility, representing the device itself.
- Sample Size: Not explicitly stated as a numerical count, but refers to "the worse case plate" and "the screws," indicating physical samples for destructive testing. Typically, biomechanical testing involves a statistically significant number of samples of the device and predicate to demonstrate equivalence; however, specific numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The "data" comes from in vitro biomechanical testing of the manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the non-clinical testing described. "Ground truth" in this context would refer to the established standards and methodologies of the ASTM documents (ASTM F382-99 and ASTM F543-07), which are developed by expert consensus within the field of biomaterials and medical devices. There are no "experts used to establish ground truth for the test set" in the sense of clinical reviewers or annotators, as this is a non-clinical, mechanical performance study.
4. Adjudication Method for the Test Set
Not applicable. This refers to methods for resolving discrepancies among multiple expert reviewers in clinical studies. No such adjudication was performed as this was non-clinical biomechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
No. This type of study is performed for diagnostic imaging devices, often involving AI. This device is a metallic bone fixation appliance, and no such clinical or AI-related study was performed. The document explicitly states: "No clinical studies were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is relevant for AI/ML medical devices. This device is a physical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study is established by:
- Standardized Biomechanical Testing Methods: ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Metallic Bone Screws).
- Performance of Predicate Devices: The measured mechanical performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
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.