(57 days)
The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Specifically.
- The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia
- The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease. such as osteoarthritis, of the lateral proximal tibia
- The TOMOFIX Lateral Distal Femur Plates are indicated for open-and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
- The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur
The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium plate families with locking and combination locking/compression holes. This system features plates designed to provide stable fixation of osteotomies of the distal femur and proximal tibia.
The DePuy Synthes TOMOFIX Medial Distal Femur Plates are part of the DePuy Synthes TOMOFIX Osteotomy System used for closed wedge femoral osteotomies. The subject plates are anatomically contoured to fit the medial distal femur, are available in right and left versions, as well as sterile and non-sterile.
The provided document is a 510(k) premarket notification for the DePuy Synthes TOMOFIX Osteotomy System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.
However, the document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device. This document pertains to traditional medical hardware (bone fixation plates) and the "performance data" refers to mechanical testing for durability and strength, not algorithmic performance.
Therefore, most of the requested information regarding AI/ML device performance and related studies (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document.
I will provide the information that is available in the document regarding the device and its testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Comparable to predicate devices | Results demonstrate substantial equivalence through: |
| Axial Testing (Osteotomized Sawbone Femur) | Comparable stiffness and fatigue strength to predicate devices | Conducted by mounting plates on an osteotomized sawbone femur model and subjecting to axial load. Results demonstrate substantial equivalence. |
| Torsion Testing (Osteotomized Sawbone Femur) | Comparable stiffness and fatigue strength to predicate devices | Conducted by mounting plates on an osteotomized sawbone femur model and subjecting to torsional load. Results demonstrate substantial equivalence. |
| Bending Stiffness (Critical Cross-Section) | Comparable stiffness and fatigue strength to predicate devices | ProEngineer CAD software used to calculate and compare stiffness properties. Results demonstrate substantial equivalence. |
| Dynamic (Fatigue) Testing (Plate-Screw Constructs) | Comparable stiffness and fatigue strength to predicate devices | Conducted by mounting plate-screw constructs on POM-C test blocks with milled surface, introducing cyclical axial force. Results demonstrate substantial equivalence. |
Explanation of "Acceptance Criteria" for this Device:
For this type of device (bone fixation plates), the "acceptance criteria" for performance are established through showing equivalence to legally marketed predicate devices. This involves demonstrating similar mechanical properties (stiffness, fatigue strength) under relevant testing conditions. The document states that the testing was "designed to assess the stiffness and fatigue strength of the subject devices" and that the "results... demonstrate substantial equivalence." This implies that the observed performance was found to be statistically and clinically comparable to the predicate devices.
Regarding AI/ML specific criteria (which are not in this document):
- Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device). The mechanical tests were performed on "osteotomized sawbone femur model[s]" and "POM-C test blocks." The specific number of samples for each mechanical test is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device). Ground truth for mechanical testing is based on physical measurements and engineering principles.
- Adjudication method for the test set: Not applicable (not an AI/ML device).
- 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 (not an AI/ML device). This is a hardware device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (not an AI/ML device).
- The type of ground truth used: For mechanical testing, the ground truth is derived from engineering principles and physical measurement of forces, displacement, and cycles to failure, often compared against established standards or predicate device performance.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (not an AI/ML 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.