(297 days)
The metallic locking bone plate and screw are intents with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
- ostcotomies, mal-unions, and non-unions;
- single, segmental, and comminuted fractures;
- normal bone density and osteopenic bone.
The proposed device, metallic Locking Bone Plate and Screw consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is manufactured with Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
This document is a 510(k) premarket notification approval for a medical device: "Metallic Locking Bone Plate and Screw". It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and material biocompatibility, rather than providing details on a study proving the device meets acceptance criteria regarding clinical outcomes or diagnostic performance.
Therefore, many of the requested elements are not applicable to the information contained in this FDA letter and summary. However, I can extract the relevant information based on the document's content.
Device Name: Metallic Locking Bone Plate and Screw
Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (indirectly inferred from testing standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Mechanical performance meeting established standards for metallic bone plates (e.g., bend testing, screw properties) | Complies with ASTM F382 - 99(2008) Standard Specification and Test Method for Metallic Bone Plates (bend testing). |
| Complies with ASTM F543 - 13 Standard Specification and Test Methods for Metallic Medical Bone Screws. | |
| Biocompatibility of materials | Made of pure titanium and Ti-6Al-4V, complying with ASTM F1472 and ASTM F67. Materials are "well-characterized" and have been "employed successfully in human implant applications in contact with soft tissue and bone for over a decade." |
| Sterilization requirements | Provided un-sterilized; "shall be sterilized prior to use by healthcare provider." |
| Single-use requirement | "The proposed devices shall never be reused." |
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 or diagnostic performance data or sample sizes for mechanical testing. The performance data provided is based on non-clinical bench testing and material specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for mechanical performance is established by recognized engineering standards (ASTM). Biocompatibility is based on material science and established historical use, not expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or diagnostic test set requiring expert adjudication was conducted.
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 device is a passive implantable device, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The ground truth for this device's performance relies on:
- Engineering Standards: Bench testing results compared against established ASTM standards for metallic bone plates and screws.
- Material Specifications and Historical Use: Biocompatibility is established by the use of materials (pure titanium and Ti-6Al-4V) that conform to ASTM standards (F1472, F67) and have a long history of successful implantation in humans.
8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or clinical trials was used. The device design and performance are based on engineering principles and material science, informed by prior knowledge and testing of similar devices and materials.
9. How the ground truth for the training set was established
Not applicable. There was no training set. The "ground truth" for the device's design and materials is derived from established engineering and material science principles, as well as the performance of predicate devices.
§ 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.