(225 days)
The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
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, and fibula.
The TDM Screws (1.5mm and larger, Solid and Cannulated) 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, and fibula.
The TDM Plate 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 locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length.
The provided text is a 510(k) premarket notification for a medical device (TDM Plate and Screw System). It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does NOT include acceptance criteria for a quantitative performance metric, nor does it describe a study that uses a test set against ground truth with experts and specific adjudication methods.
Instead, the performance data section mentions nonclinical tests and engineering analysis conducted in accordance with ASTM standards (F543-17 and F1264-16) to establish substantial equivalence. These standards are typically for mechanical properties and material compatibility, not for diagnostic or clinical performance against ground truth as would be evaluated for AI/ML-driven devices.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set). This type of information is generally found in submissions for devices that rely on algorithmic performance, often involving image analysis or diagnostic support, which is not the case for this bone fixation system.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot provide. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in a clinical or diagnostic context. The "Performance Data" section refers to mechanical tests.
2. Sample size used for the test set and the data provenance:
- Cannot provide. The document describes mechanical tests, not a study involving a test set of data (e.g., images, patient records).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the clinical or diagnostic sense for this type of mechanical device evaluation. The "ground truth" for mechanical testing would be the physical properties measured in a lab.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No such adjudication method is described as there isn't a test set with expert interpretation.
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:
- No, an MRMC study was NOT done. This type of study is relevant for AI/ML diagnostic tools, not for a bone plate and screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for mechanical testing would be direct measurements of physical properties (e.g., ultimate tensile strength, fatigue life), not expert consensus or pathology in a clinical context.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" for this device, as it is not an AI/ML-driven product.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of available "Performance Data" from the document:
The "Performance Data" section states:
"The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:
- Static 4-Point Bending
- Axial Pullout
- Torsional
The nonclinical tests and engineering analysis demonstrate that the TDM Plate and Screw Systems is as safe, as effective, and is substantially equivalent to the legally marketed predicate device."
This indicates that mechanical and material performance was evaluated, likely against the thresholds or expectations set by the referenced ASTM standards, which are considered the "acceptance criteria" for this type of device in terms of its physical integrity and performance. The study demonstrating this is the suite of nonclinical tests and engineering analysis performed according to those standards.
§ 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.