(31 days)
OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies
The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTIS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.
This 510(k) submission describes a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML specific performance criteria, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided text in the context of device acceptance criteria and study information:
Device Acceptance Criteria and Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The criteria are implicitly derived from the established safety and effectiveness of the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fretting Corrosion (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Torsional Yield Strength (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Ultimate Torque (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Insertion Torque (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Removal Torque (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Pull-Out Strength (comparable to predicate) | Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. |
| Mechanical Behavior (unchanged by modification) | Finite Element Method demonstrates that modification to OTIS-C Plus plate do not alter its mechanical behavior. |
| Fretting Corrosion (unchanged by modification) | Finite Element Method demonstrates that modification to OTIS-C Plus plate do not alter its fretting corrosion. |
Study Description:
- Sample size used for the test set and the data provenance: Not explicitly stated as this is a non-clinical, mechanical testing study. The "test set" would refer to the physical samples of the OTIS-C Plus device and its components used for the performance testing. The provenance of the data is from SCIENCE FOR BIOMATERIALS, a French company. The study is prospective in the sense that the testing was performed on the newly designed modified device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical engineering study, not an imaging or diagnostic study requiring expert interpretation for ground truth. The "ground truth" is established by the physical laws and engineering principles governing the materials and their interactions.
- Adjudication method for the test set: Not applicable. This refers to consensus methods for expert opinions, which is not relevant for mechanical testing.
- 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 not an AI/ML device or a diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: For the mechanical performance tests (fretting corrosion, torsional yield strength, etc.), the "ground truth" is the established scientific and engineering principles for material properties and device performance under specified conditions, as measured by standard laboratory tests. For the Finite Element Method (FEM) analysis, the "ground truth" or reference for comparison is the mechanical behavior and fretting corrosion of the predicate device (K100604).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.