(262 days)
Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, 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® Small Fragment Set consists of:
- LOQTEQ® Straight Plate 3.5
- LOQTEQ® Reconstruction Plate 3.5
- LOQTEQ® 1/3 Tubular Plate 3.5
- LOQTEQ® Cortical Screw 3.5, T15, self-tapping
- LOQTEQ® Cortical Screw 3.5, small head T15, self-tapping
- Cortical Screw 3.5, self-tapping
- Cortical Screw 3.5, small head, self-tapping
- Set of Instruments, Small Fragment Set
The aap LOQTEQ Small Fragment Set is a medical device used for the internal fixation of bone fractures and other bone injuries. The acceptance criteria and the study proving the device meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by ASTM F382) | Reported Device Performance |
|---|---|
| Mechanical performance, specifically implant fatigue tests with progressive loadings (worst-case scenario for clinical use) | Substantial equivalence to predicate devices (Small Fragment Locking Compression Plate (LCP®) System, Synthes (USA), and Zimmer® Small Fragment Universal Locking System) in mechanical performance. |
| Static and dynamic 4-Point bending tests | Substantial equivalence to predicate devices in mechanical performance. |
| Compliance with pre-defined requirements for safety and effectiveness | The device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
The information provided does not specify a distinct "test set" in the context of typical AI/ML studies. Instead, the performance data discussed is based on non-clinical mechanical tests. Therefore, details like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the same way they would be for studies involving human subject data or AI model validation. The testing was conducted on the device components themselves, following established ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this device's performance is established by mechanical testing according to industry standards (ASTM F382), not by expert human interpretation of data in the way an AI model's output would be validated.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" involves physical device testing against established mechanical standards, not human expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the premarket notification (510(k)) for a medical device (bone plates and screws), not an AI/ML diagnostic or prognostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or discussed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No. This device is a physical implant, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluated is the mechanical integrity and functionality of the physical device components.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on established mechanical performance standards and material properties defined by ASTM (American Society for Testing and Materials) standards, specifically ASTM F382. The device's performance is compared against these standards and against the mechanical performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" in the context of AI/ML or statistical modeling. The document describes the mechanical testing of a physical medical device.
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 submission. The "ground truth" for the device's performance is derived from compliance with specified mechanical testing protocols and comparison to predicate devices, as described in point 7.
§ 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.