(166 days)
Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.
The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.
Here's an analysis of the provided text regarding the Stryker Temporary Condylar Prosthesis, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (New Coating) | Verification and Validation Testing: Multiple tests were conducted to ensure the new coating's mechanical properties met design inputs of the originally cleared device. |
| Friction Behavior | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Roughness | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Thickness | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Wear Resistance | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Adhesion Strength | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Hardness | Conducted to verify mechanical wear. Results explicitly state the new coating does not affect safety and effectiveness. |
| Biocompatibility | Biocompatibility Tests: Performed to ensure the new coating material is biocompatible. Results explicitly state the new coating does not affect safety and effectiveness. |
| Corrosion Resistance | Corrosion Tests: Performed to ensure the new coating material is corrosion resistant. Results explicitly state the new coating does not affect safety and effectiveness. |
| Material Composition Equivalence | The new coating material is different, but the overall device retains similar technological characteristics to the predicate. The device is still made of commercially pure titanium, and connecting screws are unchanged. The purpose of the study was to demonstrate that this difference in material composition of the coating does not affect safety and effectiveness. |
| Intended Use Equivalence | The device's intended use remains unchanged from its predicate. |
| Design Equivalence | The device's design and dimensions remain exact to its predicate. |
| Operational Principle Equivalence | The device's operational principle remains unchanged from its predicate. |
Summary of the Study:
The provided document describes a 510(k) submission for a modification to the Stryker Temporary Condylar Prosthesis. The modification is a change in the material composition of the coating used on the head of the prosthesis. The study performed aims to demonstrate substantial equivalence to the previously cleared predicate device (K020199) by proving that this change in coating material does not adversely affect the safety and effectiveness of the device.
The study employed a series of Verification and Validation testing focused specifically on the new coating material and its impact on the device's overall performance.
2. Sample Sizes Used and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of tests conducted per device) used for the friction, roughness, thickness, wear resistance, adhesion strength, hardness, biocompatibility, and corrosion tests. It generally states that "Various tests... were conducted."
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a device modification, these studies are typically internal validation tests performed by the manufacturer (Stryker Leibinger GmbH & Co. KG, Germany) or their contracted labs, and are prospective in nature for the modified component.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- The document describes engineering and laboratory tests (friction, wear, biocompatibility, etc.), not clinical studies requiring expert ground truth or diagnoses. Therefore, the concept of "experts establishing ground truth" in the medical diagnostic sense is not applicable here. The "ground truth" for these tests would be established by validated test methodologies and acceptance criteria for mechanical and material properties.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human observers or diagnoses. This document describes laboratory verification and validation testing. Therefore, such adjudication methods are not applicable. The assessment of test results would be based on comparison against predefined engineering specifications and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This document describes a submission for a modified medical device focusing on material properties and performance. MRMC studies are typically conducted for diagnostic devices (e.g., AI algorithms for image analysis) to assess the impact of AI assistance on human reader performance. This is not a diagnostic device.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study was done. This is not a software algorithm or AI-powered device. Its performance is assessed through physical and chemical testing of the material and mechanical design.
7. Type of Ground Truth Used
- For the performance testing, the "ground truth" was based on engineering specifications, material science standards, and predefined acceptance criteria for mechanical, chemical, and biological properties. For example, a "ground truth" for wear resistance would be a maximum allowable wear rate as defined by relevant standards or internal specifications, against which the test results are compared. For biocompatibility, it would be compliance with ISO 10993 standards.
8. Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, so there is no "training set." The development process would involve iterative design, prototyping, and testing, but not a data-driven training set in the AI sense.
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.