(29 days)
The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
The Stryker Universal Neuro III System (UN III) is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 or higher). The UN III System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. This special 510(k) is being submitted due to dimensional modifications to the screw and screwdriver blade. There have been no modifications to the plates, meshes, or other accessory devices.
This document is a 510(k) premarket notification for the Stryker Universal Neuro III System: UN III AXS Screw and UN III AXS Screwdriver Blade. It focuses on demonstrating substantial equivalence to a predicate device following dimensional modifications. It is therefore a submission for a medical device and not for an AI/ML powered device. Hence, most of the questions relating to AI/ML powered devices are not relevant for this submission, and the information is not present in the document.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The subject device met all pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each test are not explicitly detailed. Instead, only the types of tests performed are listed.
| Test Performed | Reported Device Performance |
|---|---|
| Self-Retention Test | Met all pre-defined acceptance criteria. |
| Screw Insertion Test | Met all pre-defined acceptance criteria. |
| Life Cycle Test Fatigue (Screwdriver Blade) | Met all pre-defined acceptance criteria. |
| Torque to Failure Test Quasi Static (Screwdriver Blade) | Met all pre-defined acceptance criteria. |
| End User / End Product Test | Met all pre-defined acceptance criteria. |
| Biocompatibility testing | Not required (no change in material, manufacturing, duration/location of contact). |
| Sterility testing | Not required (no change in material, manufacturing, duration/location of contact). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a medical device submission, not an AI/ML device. The document details bench testing, not a dataset for an algorithm.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as this is a medical device submission, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.
4. Adjudication Method
This is not applicable as this is a medical device submission, not an AI/ML device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a medical device submission and not an AI/ML powered medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (screws and screwdriver blades), not an algorithm.
7. Type of Ground Truth Used
Not applicable. The performance was assessed through physical bench tests. For these tests, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML powered device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device submission.
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).