(94 days)
The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna .
The aap LOQTEQ® VA Radius Set 2.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
This document is a 510(k) premarket notification for a medical device: "aap LOQTEQ® VA Radius Set 2.5," which includes plates and screws for fixing fractures and osteotomies of the distal radius and ulna. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static and dynamic system tests
- Screws meet relevant demands of ASTM F543-13 | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained.
The screws fulfill the relevant demands of ASTM F543-13. |
| Safety and Effectiveness: - Meets requirements of pre-defined acceptance criteria
- Meets intended uses | The subject 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 the data provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The studies mentioned are non-clinical (mechanical tests) and thus do not involve patient data or data provenance (country of origin, retrospective/prospective). The studies involve device components and system performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The studies are non-clinical mechanical tests, not dependent on expert interpretation of clinical data.
4. Adjudication method for the test set
Not applicable. The studies are non-clinical mechanical tests.
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. This is a notification for a hardware device (bone plates and screws), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" would be established by:
- Engineering specifications and design requirements.
- Industry standards (e.g., ASTM F543-13 for screws).
- Comparative performance data against predicate devices.
8. The sample size for the training set
Not applicable. The studies are non-clinical mechanical tests and do not involve a training set as understood in AI/machine learning contexts.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the context of this device and its studies.
§ 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.