(90 days)
The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.
The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.
Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.
Device Name: TITAN 3-D® Wedge System
Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.
| Acceptance Criterion (Type) | Specific Test/Standard | Reported Device Performance (Outcome) |
|---|---|---|
| MR Safety & Compatibility | ASTM F2119 | Image Artifact (Pass) |
| ASTM F2052 | Magnetically Induced Displacement Force (Pass) | |
| ASTM F2213 | Magnetically Induced Torque (Pass) | |
| ASTM F2182 | Radiofrequency (RF) Induced Heating (Pass) | |
| Mechanical Performance | Dynamic Compression | Verified change does not raise new questions of safety and effectiveness (Pass) |
| Static Compression | Verified change does not raise new questions of safety and effectiveness (Pass) | |
| Static Compressive Shear | Verified change does not raise new questions of safety and effectiveness (Pass) |
Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.
- Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
- Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is an implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/software product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See explanation for #8.
§ 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.