(67 days)
The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
The Stryker Leibinger Resorbable Fixation System is a modification of the Howmedica Leibinger Resorbable Fixation System, K982531. This second generation of products includes plates and screws in various configurations. Plates include but are not limited to straight, curved, "X", "Y", zigzag, "L", box, ladder, and panel designs in varying lengths which are attached to the bone using screw fixation. The plates have a thickness of 1.0mm. The system also contains a mesh which is available in a thickness of 0.7mm. Screws are available in 1.7 mm, 2.0 mm and 2.2 mm diameters and standard craniofacial lengths. The plates and mesh can be intraoperatively contoured by heating. The subject device is fabricated from a polylactide and polyglycolide terpolymer. Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.
This document describes a 510(k) submission for the Stryker Leibinger Resorbable Fixation System. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It is not a clinical study designed to test acceptance criteria based on performance endpoints. Therefore, most of the requested information is not applicable to this type of regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is showing substantial equivalence to existing predicate devices. This is demonstrated by comparing material, design, operational principle, and intended use. Specific quantitative performance acceptance criteria are typically not defined in such a summary, as the focus is on a comparative assessment rather than absolute performance targets.
- Reported Device Performance: The summary states that "Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device." This is the key performance claim made.
| Acceptance Criteria (for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Howmedica Leibinger Resorbable Fixation System, LactoSorb Trauma Plating System, Macropore Protective Sheet, BiosorbFX 1.5/2.0 Bioabsorbable Fixation System) in material, design, operational principle, and intended use. | The Stryker Leibinger device is found to be substantially equivalent to the aforementioned predicate devices. |
| Mechanical strength equivalent to a predicate device. | Mechanical testing showed the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device. |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission, not a stand-alone clinical study. The "test set" in this context would refer to data used for mechanical testing for equivalence.
- Sample Size: Not specified. Mechanical testing typically involves a sufficient number of samples to demonstrate statistical equivalence, but the exact number is not disclosed in this summary.
- Data Provenance: Not specified, but generally, such testing is performed in-house by the manufacturer or by a contracted laboratory. It is implied to be laboratory testing rather than human subject data. The data is retrospective in the sense that it was performed on manufactured devices for comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood in clinical or AI studies (e.g., expert consensus on medical images) is not relevant for this type of mechanical equivalence testing. The "ground truth" here is the established mechanical properties of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device submission for a physical implantable system, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device. "Standalone performance" in this context could refer to the mechanical performance of the device itself, which was established as equivalent to a predicate device through mechanical testing.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" was likely the established mechanical properties (e.g., strength, stiffness) of the Walter Lorenz LactoSorb device, a legally marketed predicate device. This would be based on its specifications, published data, or direct testing of the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, 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.
§ 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.