(112 days)
The PRO Plating System is indicated for:
· Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum
• Sacroiliac joint dislocations
The Stryker Trauma Pelvic Set (Matta) is indicated for:
• Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;
• Revision surgery of pseudarthrosis, non-unions and mal-unions;
• Osteonomies;
• Arthrodeses;
• Sacroilic joint dislocations;
• Symphysis pubis disruptions
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the PRO Plating System, to align indication of the existing PRO Pelvis System and the new devices and add MRI labeling to the existing PRO Pelvis System and the Trauma Pelvic Set System (Matta). This submission encompasses multiple systems (PRO Pelvis System and Trauma Pelvic Set System (Matta)) that have similar intended use and/or will be used together during the surgical procedure.
The PRO Plating System (Pelvis II Implant System) is an internal fixation device that consists of different types of plates used with compatible screws to fit different types of fractures in the pelvis. All devices in the system are provided sterile and non-sterile.
The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, and washer components of various sizes. All are manufactured from stainless steel (ASTM F-138/139). All devices in the system are provided sterile and non-sterile.
This document describes a 510(k) premarket notification for the Stryker PRO Plating System and Stryker Trauma Pelvic Set (Matta). This submission is for a medical device (bone fixation appliances and accessories), not for an AI/ML powered device. As such, the sections regarding AI/ML performance criteria, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.
Here's a summary of the non-clinical performance data provided, as relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Single Cycle Bend (per ASTM F382) | Demonstrated resistance to bending under single load. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| Bending Fatigue (per ASTM F382) | Demonstrated durability under repeated bending loads. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| MRI Compatibility: Magnetic Induced Displacement (per ASTM F2052) | Acceptable magnetic attraction in an MRI environment. | Performed: Testing conducted as per ASTM F2052. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Magnetic Induced Torque (per ASTM F2213) | Acceptable torque in an MRI environment. | Performed: Testing conducted as per ASTM F2213. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: RF Heating (per ASTM F2182) | Acceptable temperature rise in an MRI environment. | Performed: Testing conducted as per ASTM F2182. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Image Artifacts (per ASTM F2119) | Acceptable level of image distortion in an MRI environment. | Performed: Testing conducted as per ASTM F2119. (Specific results not provided but deemed acceptable for clearance.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the exact sample sizes used for each non-clinical test. For mechanical and MRI compatibility testing of medical devices, samples are typically chosen to represent the range of device types, sizes, and materials. The data provenance is implied to be from internal laboratory testing conducted by Stryker or a qualified testing facility, relevant to the manufacturing location (Selzach, Switzerland) and for the US market. The data is non-clinical/pre-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device that requires expert-established ground truth for its performance assessment. The "ground truth" for this type of device is established through engineering and material science principles, and adherence to recognized standards like ASTM.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device requiring human adjudication of its output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this is not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm, so standalone performance in the context of AI/ML is irrelevant.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on established engineering principles, material science, and conformance to recognized consensus standards (e.g., ASTM F382, F2052, F2213, F2182, F2119). These standards define the methodologies and acceptable performance metrics for the tested properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device.
§ 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.