(182 days)
The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur
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 LOQTEQ® Distal Lateral Femur Plate 4.5 System consists of: LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5
The provided text describes a medical device, the "aap LOQTEQ® Distal Lateral Femur Plate 4.5 System," and its non-clinical testing for safety and effectiveness. However, it does not include information about a study involving AI, human readers, or image interpretation. Therefore, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment for a test set cannot be filled from the provided document.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance similar to the predicate device (LCP® Distal Femur Plates of Synthes) | "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained." |
| Periprosthetic Screws fulfill relevant ASTM F543-07 requirements and pre-defined criteria | "The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses." |
| Overall safety and effectiveness | "The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." (This is a conclusion based on the tests.) |
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: Not specified in terms of number of plates/screws or iterations. The description only mentions "Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use" and "Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07." These are likely conducted on a defined number of physical samples according to the standard, but the exact count isn't in the provided text.
- Data Provenance: Not specified. The tests are non-clinical, meaning they were conducted in a laboratory setting, not with human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This study is a non-clinical mechanical test of a physical implant, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the physical properties measured against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. This is not an AI or diagnostic study requiring adjudication of expert opinions.
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. The provided document describes the mechanical testing of a medical implant, not an AI system or diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The document describes mechanical testing of a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Engineering Standards and Specifications: The "ground truth" for the mechanical tests is the pre-defined acceptance criteria based on established engineering standards (e.g., ASTM F543-07) and comparison to the predicate device's mechanical performance.
8. The sample size for the training set
- Not applicable. There is no AI or machine learning component described, so no training set was used.
9. How the ground truth for the training set was established
- Not applicable. There is no AI or machine learning component described, so no training set or its ground truth establishment is relevant here.
§ 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.