(269 days)
Mini and Mid Locking Plate and Screw System:
The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.
Small Locking Plate and Screw System:
The small locking plate and screw system is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula and other small bones.
The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.
The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical, or cancellous from 1.5mm to 4.0mm in diameter and range from 6mm to 70mm in length.
This document is a 510(k) summary for the TDM Plate and Screw System. It does not describe a study involving an AI/CADeX device or human readers. The acceptance criteria and the study to prove the device meets those criteria are entirely focused on mechanical and material properties of the bone plates and screws.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study/Test Method) | Reported Device Performance |
|---|---|
| ASTM F382-14: "Standard Specification and Test Method for Metallic Bone Plates" | The mechanical test data demonstrates that the TDM Plate and Screw System is adequate for its intended use. |
| ASTM F543-13: “Standard Specification and Test Methods for Metallic Medical Bone Screws" | The mechanical test data demonstrates that the TDM Plate and Screw System is adequate for its intended use. |
| LAL bacterial endotoxin testing | LAL bacterial endotoxin testing was conducted. (Implied to meet acceptance if deemed safe.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested). The provenance of this test data would be the testing facility that performed the ASTM standards and LAL testing, likely a laboratory associated with TDM Co. Ltd. or a contracted testing service. This testing is inherently prospective in nature, as it's performed specifically to demonstrate compliance for regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a mechanical implant, not an AI/CADeX device requiring expert interpretation of images to establish ground truth. The "ground truth" for this device is based on established engineering standards for strength, durability, and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The TDM Plate and Screw System is a physical implant for bone fixation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical bone plate and screw system, not an algorithm or AI product.
7. Type of Ground Truth Used
The ground truth used for this device's acceptance is based on adherence to established engineering standards (ASTM F382-14 and ASTM F543-13) and biocompatibility testing (LAL bacterial endotoxin testing). These standards define the acceptable mechanical properties and safety profiles for such medical devices.
8. Sample Size for the Training Set
This is not applicable. The TDM Plate and Screw System is a manufactured medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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.