(205 days)
The Pioneer Sternal Assist Implant 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 Assist Implant System consists of implantable plates for use with the Pioneer Sternal Cable System or USP #5, 6, or 7 Stainless Steel wire as a supplemental fixation to provide fixation for sternotomies and sternal fractures. The components are made of PEEK (polyetheretherketone) per ASTM F2026. The purpose of this submission is to introduce a new sternal closure system to interstate commerce.
The provided text describes the Pioneer Sternal Assist Implant System and its 510(k) summary (K120016). This document is primarily concerned with the mechanical and design equivalence of a medical device (surgical sternal plates and cables) to predicate devices, rather than an AI/ML powered diagnostic device. Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance related to strength equivalent to or better than predicate devices. | Static and dynamic testing demonstrated that performance related to strength was equivalent to or better than the predicate devices. |
| Performance related to cut-through resistance equivalent to or better than predicate devices. | Static and dynamic testing demonstrated that performance related to cut-through resistance was equivalent to or better than the predicate devices. |
| Mitigation of risk of wear. | Testing and engineering analysis were provided to mitigate the risk of wear and show that no new issues of safety or effectiveness were raised. |
| Similarities of intended use, mechanical strength, design, and physical characteristics compared to predicate devices. | Equivalence for the Pioneer Sternal Assist Implant System is explicitly stated to be based on "similarities of intended use, mechanical strength, design, and physical characteristics when compared to predicate devices." The performance data section supports the mechanical strength, design, and physical characteristic claims, and the "Intended Use" section clearly outlines the intended use which is compared to predicates by the FDA's substantial equivalence determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The study described is a mechanical performance study on the device itself, not a clinical study involving a test set of patient 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)
This information is not applicable/provided. The study focuses on mechanical testing of the device, not on interpreting patient data with ground truth established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as above.
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
This information is not applicable/provided. The device is an implantable surgical system, not an AI/ML diagnostic reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through physical mechanical testing according to predefined engineering standards and comparisons to predicate device performance. It is not expert consensus on diagnostic images, pathology, or clinical outcomes data in the context of an AI/ML diagnostic.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of mechanical testing for a physical implantable device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no training set for this type of device.
Summary of the Study that Proves Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria was a series of static and dynamic mechanical tests and engineering analysis. These tests were designed to compare the performance of the Pioneer Sternal Assist Implant System against its predicate devices in terms of:
- Strength: The ability of the device to withstand forces without breaking or deforming excessively.
- Cut-through resistance: The ability of the implant components to resist being cut or damaged by the cerclage wires/cables used for fixation.
- Wear: Analysis and testing to ensure that the device does not excessively wear over time, which could lead to failure or adverse events.
The conclusion drawn from this testing and analysis was that the Pioneer Sternal Assist Implant System's performance was equivalent to or better than the predicate devices for strength and cut-through resistance, and that the risk of wear was mitigated. This mechanical equivalence, along with similarities in intended use, design, and physical characteristics, formed the basis for the FDA's substantial equivalence determination.
§ 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.