(87 days)
The Tritium Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
The Tritium Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Sternal Cable Plate System can be used with traditional monofilament wire or Pioneer Sternal Cable. Instrumentation has been designed specifically for use with this system of implants, which may be implanted via an open or minimally invasive approach. The purpose of this submission is to add an additional implant to the predicate Tritium Sternal Cable Plate System.
This document describes the Tritium Sternal Cable Plate System, a medical device intended for stabilizing fractures of the anterior chest wall, including sternal fixation after sternotomy and sternal reconstructive surgical procedures.
Here's an analysis of the acceptance criteria and study aspects based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | - Static and Dynamic Tensile Strength Testing: Performed on the worst-case configuration. |
| Equivalent Safety | - Comparison to Predicate Devices: "Non-clinical performance testing concluded the subject product is expected to be as safe, as effective, and perform as well as or better than the predicate." |
| Equivalent Effectiveness | - Comparison to Predicate Devices: "Non-clinical performance testing concluded the subject product is expected to be as safe, as effective, and perform as well as or better than the predicate." |
| Technological Characteristics Equivalence | - Basic Design: Similar to predicates (screws and plates of various sizes and configurations, threaded plate-screw interface, may be used with cerclage). |
| - Materials: Similar to predicates (CP titanium and titanium alloy). | |
| - Design (sizes and dimensions): Equivalent or comparable to predicates. | |
| No New Safety/Effectiveness Issues | - "There are no significant differences between the subject and predicate devices' technological characteristics which would raise new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The determination of substantial equivalence was not based on clinical performance data."
Therefore, there was no test set of clinical data (e.g., patient samples, images, or real-world outcomes) used to prove the device meets acceptance criteria. The evaluation was based on non-clinical performance data (engineering analysis and mechanical testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation relied on engineering principles and comparison to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The evaluation was based on non-clinical performance data and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (sternal cable plate system), not an algorithm or AI system.
7. The type of Ground Truth Used:
The "ground truth" in this context refers to established engineering principles, material standards (ASTM F-67, ASTM F-136), and the performance characteristics of previously cleared predicate devices. The determination of device performance was based on:
- Engineering analysis: Demonstrating that the design met specified requirements.
- Non-clinical performance testing: Specifically, "static and dynamic tensile strength testing."
- Comparison to predicate devices: Establishing that its characteristics were "equivalent or comparable" and performed "as well as or better than the predicate."
8. The Sample Size for the Training Set:
Not applicable. As this is not an AI or machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.