(46 days)
The Pioneer 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.
The Pioneer Sternal Cable Plate System contains various configurations of plates, some with integrated cables and crimps, and Ø2.7mm and 3.0mm self-drilling screws (lengths 8-20mm) to allow for multiple anterior chest wall and sternal repair and reconstruction options. The implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy. The implants may be implanted via an open or minimally invasive approach using Class I (exempt) orthopedic manual surgical instruments. The purpose of this submission is to add additional implant configurations to the system.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Static and Dynamic Tensile Tests) | Pioneer Sternal Cable Plate System performs in a manner substantially equivalent to predicate systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the static and dynamic tensile tests. It refers to "Static and Dynamic Tensile Tests" as the pre-clinical performance data. Since these are bench tests for mechanical strength, the "test set" would refer to the physical specimens of the device that underwent testing.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be entirely pre-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is a pre-clinical bench test of mechanical properties, not a clinical study involving expert evaluation or ground truth based on medical diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a pre-clinical bench test and does not involve human readers or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
This information is not applicable as the study described is a pre-clinical bench test of a medical device (sternal cable plate system), not an AI-assisted diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable as the device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this pre-clinical study effectively comes from established engineering standards and requirements for mechanical strength and durability for sternal fixation devices. The comparison is made against the performance of legally marketed predicate devices, implying that their performance serves as the benchmark or "ground truth" for acceptable mechanical properties.
8. The Sample Size for the Training Set
This information is not applicable as the study is a pre-clinical bench test of a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 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.