(200 days)
The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone
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 with 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® Proximal Humerus Plate 3.5 System consists of: LOQTEQ® Proximal Humerus Plate 3.5, short . LOQTEQ® Proximal Humerus Plate 3.5, long ◆ . LOQTEQ® Cortical Screw 3.5, T15, self-tapping LOQTEQ® Cancellous Screw 3.8, T15 ● . Cortical Screw 3.5, self-tapping . Set of Instruments, Proximal Humerus Plate Material: Plates are made of Ti6Al4V (ASTM F136 or ISO 5832-3) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
The device in question is the LOQTEQ® Proximal Humerus Plate 3.5 System. The study supporting its acceptance is a non-clinical mechanical testing study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in mechanical performance. | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. |
| Device is safe and effective. | The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Meets requirements of pre-defined acceptance criteria. | The subject device...meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Meets intended uses. | The subject device...meets the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Fatigue implant tests with progressive loadings, representing worst case scenario," but does not give a specific number of implants tested.
- Data Provenance: The study was a non-clinical (mechanical) test, implying it was conducted in a laboratory setting, not on human subjects. The company, aap Implantate AG, is based in Berlin, Germany, suggesting the tests were likely performed in Germany or under their direct supervision. The data is retrospective in the sense that it was conducted before the submission for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" for a mechanical testing study is typically defined by engineering specifications, material science principles, and established testing standards, not by expert consensus in a clinical context. The "experts" involved would be engineers and material scientists conducting and evaluating the tests, but their number and specific qualifications are not detailed here.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For mechanical testing, the "adjudication" is based on objective measurements and comparison against predefined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This was a non-clinical mechanical testing study, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This was a physical medical device (bone plate and screws) being tested for its mechanical properties, not an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on engineering specifications and mechanical performance standards. The study aimed to demonstrate "substantial equivalence with respect to the mechanical performance" to a predicate device, and that the device "meets the requirements of its pre-defined acceptance criteria." These criteria would be derived from biomechanical principles and established performance benchmarks for such implants.
8. Sample Size for the Training Set
No training set was used in this context. This was a non-clinical validation study for a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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.