(66 days)
The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
The TriMed Clavicle Fixation Plates are designed to provide total immobilization of the clavicle. The plates utilize 2.7mm and 3.2mm locking cortical screw to secure the plates to the bone. All plates and screws are similar to predicate devices. The TriMed Clavicle Fixation Plates are available in a variety of shapes and sizes to provide superior and anterior fixation of the clavicle.
The provided text describes a 510(k) submission for the TriMed Clavicle Fixation System. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or standalone performance evaluations.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. The primary "study" conducted for this device is an engineering analysis comparing its mechanical properties to those of existing devices.
Here's a breakdown of the information as it relates to the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Comparison |
|---|---|
| Mechanical Performance: | |
| Bending Strength (implied, not explicitly stated as a numerical criterion) | An engineering analysis was conducted to compare the bending strength of the TriMed Clavicle Fixation Plates to predicate devices. The submission implies that the TriMed devices demonstrate comparable or acceptable bending strength to justify safety and effectiveness relative to the predicates. |
| Indications for Use Equivalence: | "Substantial equivalence is based upon similarities in design features and overall indications for use" with K100944 (Clavicle Locking Plating System) and K012655 (Congruent Bone Plate System). |
| Design Features Equivalence: | The plates utilize 2.7mm and 3.2mm locking cortical screws, and all plates and screws are similar to predicate devices. The plates are available in various shapes and sizes for superior and anterior fixation. |
Note: The 510(k) process for this type of device does not typically require the establishment of specific numerical performance acceptance criteria and a detailed study proving the device meets those in the way, for example, a diagnostic AI device would. Instead, the focus is on demonstrating that the device is as safe and effective as a legally marketed predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical or performance test set (in the sense of a data set for an algorithm) was described. The "test" involved an engineering analysis comparing the device's mechanical properties to predicates.
- Data Provenance: Not applicable. The "data" comes from the engineering analysis, comparing the new device's specifications and performance to specifications of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth, in the context of an AI device, is not relevant here as this is a medical implant, not an AI diagnostic tool. The "ground truth" for proving substantial equivalence relies on established engineering principles and comparison to predicate device specifications.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no test set requiring expert adjudication.
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
- MRMC Study: Not applicable. This is a medical implant (clavicle fixation system), not an AI diagnostic or assistive device. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of typical AI algorithm validation. For this 510(k) submission, the "truth" for substantial equivalence is derived from:
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. 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.