(14 days)
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
The provided text describes a Special 510(k) submission for the Stryker® Patient Specific Polymer Implant, focusing on sterilization and a change in manufacturing location. The study's purpose is to demonstrate equivalence to the predicate nonsterile devices.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Sterilization via ISO 11137-2 | Achieved |
| Pyrogenicity testing via LAL test according to ANSI/AAMI ST72:2002 | Achieved |
| Bioburden testing to ISO 11137-2 | Conducted |
| Packaging validated to maintain sterility throughout labeled shelf-life (6 months) | Achieved |
| Integration of newer versions of Materialise software with full validation | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests conducted (sterilization, pyrogenicity, bioburden, packaging validation). It also does not provide information on data provenance (country of origin, retrospective/prospective) beyond stating that "Testing has been performed."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies performed are primarily laboratory-based equivalency testing (sterilization, pyrogenicity, packaging), not studies that would typically involve expert-established ground truth in the context of device performance in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where expert review is needed to establish ground truth from ambiguous or complex cases. The tests described are objective laboratory analyses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications related to sterilization and manufacturing, not on the clinical effectiveness or performance of the implant compared to human readers or other devices in a diagnostic or clinical decision-making context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable to this device. The Stryker® Patient Specific Polymer Implant is a physical implant, not a software algorithm or AI system for diagnostic or clinical decision support. While the manufacturing process involves commercially available software (Materialise), the submission does not detail standalone performance of this software in a clinical context but rather its integration and validation within the manufacturing process.
7. The Type of Ground Truth Used
For the studies mentioned (sterilization, pyrogenicity, bioburden, packaging validation), the "ground truth" is established by adherence to recognized international and national standards (ISO 11137-2, ANSI/AAMI ST72:2002) and validated laboratory testing protocols. These are not clinical ground truths (e.g., pathology, outcomes data) but rather objective measures of manufacturing and product quality.
8. The Sample Size for the Training Set
This is not applicable and therefore not provided. The device is a physical implant, and the submission describes manufacturing and sterilization validation, not the development of an AI algorithm or model that would require a training set. The "Materialise software" is mentioned as a commercially available tool integrated into the manufacturing process, implying it's not a newly developed algorithm by Stryker for this specific submission that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.