(64 days)
The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.
The predicate Universal CMF System, which was cleared in K022185, is intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System consists of an implant module for the respective anatomical and indicated areas with each containing various screw and plate versions and shapes. The Subject Device of this submission are the Upper-Face AXS screws and Mid-Face AXS (Subject Device) screws. This special 510(k) is submitted due to modifications made to the Subject Device. There have been no modifications to the plates, or meshes of the Predicate Device.
This document describes a 510(k) premarket notification for the Stryker Upper-Face AXS screws and Mid-Face AXS screws, which are part of the Stryker Universal CMF System. This is a Class II medical device (Bone Plate, 21 CFR 872.4760, Product Code JEY).
The submission is a special 510(k), indicating modifications were made to the subject device, but the overall indications for use remain the same as the predicate device (Stryker Universal CMF System – K022185).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The Subject Device must meet all pre-defined acceptance criteria set for the Verification & Validation (V&V) testing. | The Subject Device met all pre-defined acceptance criteria, as stated in the "Performance Bench Testing" section. |
| The Subject Device must perform as intended in the specified use conditions. | The results of the V&V tests data demonstrate that the Subject Device will perform as intended in the specified use conditions. |
| Technological characteristics of the Subject Device (after modifications) must remain equivalent to the Predicate Device. These include: |
- Same operating principle
- Same mode of fixation (plate fixation with screws)
- Same area of contact and contact duration (screws have contact to tissue/bone for >30 days)
- Same material | The document states under "B. Technological Characteristics" that "Even with the modification to the Subject Device... the technological characteristics remain the same as the Predicate Device," enumerating these points. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of screws or tests) used for the bench testing. It only generally refers to "Verification and Validation (V&V) testing" being performed.
Data Provenance: The testing was "Performance Bench Testing," implying laboratory-based, in-vitro testing. No country of origin for the data is specified, but the submitter is based in Germany (Stryker Leibinger GmbH& Co. KG) and the contact person is in Portage, Michigan, USA. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a bone plate and screw system, and the studies performed are bench performance testing, not studies requiring expert interpretation of diagnostic images or clinical outcomes that would necessitate establishing a "ground truth" by medical experts. The acceptance criteria are based on engineering and performance specifications.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is bench performance testing, not a study involving human interpretation or clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a physical implant device, and its regulatory clearance is based on engineering performance tests and substantial equivalence to a predicate device, not on diagnostic accuracy or reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the "Performance Bench Testing" can be considered a standalone performance evaluation of the device itself (the screws) against predefined engineering criteria, without human interaction during the test execution beyond setting up the experiment. This report focuses on the physical device's performance, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing would be the engineering specifications, established mechanical properties (e.g., strength, stiffness, fatigue life), and functional performance requirements derived from the intended use and comparison to the predicate device. These are objective, measurable parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.