(54 days)
BaiDe® locking plate system is intended for adult patients as indicated for fixation of tibia.
BaiDe" locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.
The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
This document is a 510(k) premarket notification for a medical device called the "BaiDe® locking plate system," which is intended for orthopedic fixation. It does not describe an AI/ML powered medical device, therefore, the requested information about acceptance criteria for AI performance is not applicable.
The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical properties rather than algorithm performance.
Here's a breakdown of the relevant information present:
Device Type: Medical device for orthopedic fixation (locking plate system).
Acceptance Criteria and Device Performance (Based on non-clinical bench testing):
| Acceptance Criteria (Measured item) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F 382-99 (Reapproved 2008) Metallic Bone Plates: Static four-point bending | Complies with standard |
| ASTM F 382-99 (Reapproved 2008) Metallic Bone Plates: Dynamic four-point bending | Complies with standard |
| ASTM F 543-07 Metallic Medical Bone Screws: Torsional properties | Complies with standard |
| ASTM F 543-07 Metallic Medical Bone Screws: Driving torque | Complies with standard |
| ASTM F 543-07 Metallic Medical Bone Screws: Pull out test | Complies with standard |
Study Details (for non-clinical bench testing):
- Sample size used for the test set and the data provenance: Not explicitly stated as a number of samples, but "Bench tests were conducted." The provenance is internal to the manufacturer's testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical bench tests against engineering standards, not clinical evaluations requiring expert interpretation.
- Adjudication method for the test set: Not applicable for engineering bench tests.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Established by engineering standards (ASTM F 382-99, ASTM F 543-07).
- The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device bench testing in this context.
- How the ground truth for the training set was established: Not applicable.
Summary in relation to your request:
This document describes the regulatory submission for a physical medical implant. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not relevant to this specific filing. The "acceptance criteria" here refer to conformance with established mechanical testing standards for bone plates and screws.
§ 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.