(84 days)
The aap Radius Set 2.5 is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap Radius Set 2.5 consists of:
Extra-art. Radius Plate WSP 2.5, (left and right version)
Juxta-art. Radius Plate WSP 2.5, (left and right version)
L-Plate WSP 2.5, (left and right version)
Straight Plate WSP 2.5
T-Plate WSP 2.5
Cortical Screw WS 2.5, self-tapping (locking bone screw)
Cortical Screw 2.5, self-tapping
Set of Instruments, Radius Set 2.5
The aap Radius Set 2.5 is a device indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
Here's an analysis of the provided information regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on mechanical performance to establish substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue implant tests with progressive loadings: Represent worst-case clinical scenario. | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Mechanical tests of Screws acc. to ASTM F543-07: Fulfil relevant requirements. | The Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the specific sample sizes for the mechanical tests (e.g., number of plates, screws, or test repetitions). It only mentions "fatigue implant tests with progressive loadings" and "Mechanical tests of Screws acc. to ASTM F543-07."
The data provenance is non-clinical testing, performed by the manufacturer, aap Implantate AG, in Germany. The study is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence, rather than being a retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on non-clinical mechanical testing based on established engineering standards (ASTM F543-07), not on expert consensus for clinical image interpretation or diagnosis. The "ground truth" here is adherence to specified mechanical properties.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on objective mechanical testing results against established standards, not on human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic or screening devices where human interpretation is involved. For a bone fixation device, the primary evaluation is mechanical performance.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The "Summary of Non-clinical tests" describes mechanical tests performed on the device components (implants and screws) to demonstrate their effectiveness and safety against pre-defined acceptance criteria and established standards (ASTM F543-07). This is a standalone evaluation of the device's physical properties and performance.
7. Type of Ground Truth Used
The type of ground truth used is engineering specifications and established mechanical testing standards. Specifically:
- Pre-defined acceptance criteria for fatigue implant tests.
- ASTM F543-07 for mechanical tests of screws.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of 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.