(73 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. 2.7mm and 3.0mm diameter self-drilling screws (lengths 8-20mm) to allow for multiple sternal repair and reconstruction options. The Pioneer Sternal Cable Plate System implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy.
The provided document describes the Pioneer Sternal Cable Plate System, a medical device for stabilizing and fixing anterior chest wall fractures. However, it does not contain information about acceptance criteria, device performance metrics, or a study that specifically "proves" these criteria are met in the way a diagnostic AI device would be evaluated.
This document is a 510(k) summary for a mechanical medical device (implants for bone fixation). The performance data cited is for mechanical equivalence testing, not for a diagnostic algorithm.
Therefore, many of the requested categories (sample size, data provenance, experts for ground truth, adjudication, MRMC, standalone algorithm, ground truth type, training set size, and ground truth for training set) are not applicable to the information provided in this regulatory submission for the Pioneer Sternal Cable Plate System.
Here's a breakdown of what is available based on the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate devices. | Screw-Plate Interface Tests: Conducted to demonstrate performance. (Details not provided on specific metrics or acceptance thresholds in this summary document, but implied to be equivalent to predicates.) |
| Static and Dynamic Tensile Tests: Conducted to demonstrate performance. (Details not provided on specific metrics or acceptance thresholds in this summary document, but implied to be equivalent to predicates.) | |
| Dimensional Compatibility: Equivalent to predicate devices. | Dimensional Comparisons: Performed to support substantial equivalence. (Details not provided on specific comparisons or acceptance thresholds in this summary document, but implied to be within acceptable ranges for equivalence.) |
| Material Compatibility: Use of medical-grade materials. | Implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy, which are standard materials for medical implants, supporting material compatibility and safety. |
| Intended Use: Similar to predicate devices. | The intended use for stabilization and fixation of fractures of the anterior chest wall (including sternotomy and reconstructive procedures) is stated to be similar to legally marketed predicate devices, forming the basis for substantial equivalence for clinical application. |
Explanation for the nature of equivalence claimed: This 510(k) summary focuses on demonstrating "substantial equivalence" of the Pioneer Sternal Cable Plate System to existing legally marketed predicate devices. For mechanical devices like bone plates and screws, this typically involves showing that the new device has similar designs, materials, and equivalent mechanical performance to predicate devices under specified test conditions. The goal is to ensure the device performs safely and effectively without raising new safety or effectiveness concerns compared to already approved devices. The specific acceptance criteria (e.g., maximum deflection under load, fatigue life) would have been part of the full 510(k) submission, but are generalized here as "performs in a manner substantially equivalent to that of predicate systems."
The Study that Proves the Device Meets Acceptance Criteria:
The document states: "Performance Data: Screw-Plate Interface Tests, Static and Dynamic Tensile Tests, and dimensional comparisons were provided to support that the Pioneer Sternal Cable Plate System performs in a manner substantially equivalent to that of predicate systems. No new issues of safety or effectiveness were raised."
This refers to a series of benchtop mechanical performance tests and dimensional analyses comparing the Pioneer Sternal Cable Plate System to its predicate devices. The study is this set of mechanical and dimensional comparisons.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified in this summary. For mechanical tests, the "sample size" would refer to the number of test specimens (e.g., plates, screws, cable assemblies) subjected to each specific mechanical test (tensile, fatigue, etc.). These are not human or patient samples.
- Data provenance: Benchtop testing (laboratory-generated data). Not applicable for country of origin or retrospective/prospective in the sense of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For mechanical device testing, "ground truth" is established by engineering specifications, material standards (e.g., ASTM), and comparison to predicate device performance, not by expert medical review of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective interpretations (like image diagnosis) where multiple readers might disagree. Mechanical tests yield objective quantitative data.
5. 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. This is a mechanical device, not a diagnostic algorithm or an AI-assisted tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Standardized Test Methods: The "ground truth" for mechanical performance would be defined by established ASTM or ISO standards for testing orthopedic implants, and the performance characteristics of the predicate devices. For material composition, it's compliance with ASTM medical grade titanium standards.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 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.