(116 days)
The Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delaved secondary reconstruction and secondary mandibular reconstruction.
The Customized Mandible Recon Plate Kit includes customized, patient specific implants, the Customized Mandible Recon Plates. Additionally, the kit includes the Instruction for Use (IFU) and a printed version of the Design Proposal approved by the surgeon prior to plate manufacture. It may include an anatomical model, named Mandible Model. The Customized Mandible Recon Plates (CMRP) and the corresponding Mandible Model are designed and manufactured for one specific patient. The products are ordered by a surgeon on a patient-by-patient basis over an internet platform referred to as the "eRequest Lifecycle online ordering system" which was already cleared with K111065 for ordering patient specific polymer implants to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. Based on patient specific anatomical data (CT-scan) and input from the surgeon, a virtual mandible recon plate with its specific dimensions (profile heights, length and 3D run of the plate, number and position of screw holes and bar strengthening) is created using the Customized Mandible Recon Plate Design Process (CMRP-DP) including the Plate Design Software (PDS). Screenshots of the virtual plate are then presented to the surgeon in the Design Proposal (pdf-file). After the surgeon approves the Design Proposal via the above mentioned eRequest Lifecycle online ordering system, the Customized Mandible Recon Plate, as well as the Mandible Model (if ordered by the surgeon), are manufactured according to the specifically set design requirements. Once the manufacturing process is finalized and the devices are cleaned, they are packed, labeled and shipped to the location specified during the ordering process. The CMRP implant is compatible with the Stryker Universal Mandibular System. Additionally. Stryker offers customized cutting and drill guides for use with the Customized Mandible Recon Plate.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker Customized Mandible Recon Plate Kit:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary explicitly states that: "The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable."
Unfortunately, the document does not provide specific quantitative acceptance criteria values or detailed quantitative device performance results for each test. It only lists the categories of tests performed and the relevant standards. Therefore, I can only provide a table with the types of tests and the general outcome reported.
| Acceptance Criteria Category | Reported Device Performance | Relevant Standards (where stated) |
|---|---|---|
| Biocompatibility | Met acceptance criteria | DIN EN ISO 10993 ff as valid 2013 (Part 1) |
| Cleaning Validation | Met acceptance criteria | EN ISO 15883-1:2009, DIN EN ISO 17664:2004 |
| Sterilization (validation) | Met acceptance criteria | ISO 11138-1:2006, DIN EN ISO 11737-1:2009, DIN EN ISO 11737-2:2009, DIN EN ISO 14161:2011, DIN EN ISO 14937:2009, DIN EN ISO 17665-1:2006, DIN ISO/TS 17665-2:2009 |
| Multiple Reprocessing | Met acceptance criteria | (Standards for sterilization and cleaning are implied) |
| Residual Moisture after Sterilization | Met acceptance criteria | (Implied by sterilization standards) |
| MRI Conditional | Met acceptance criteria | (Standard not explicitly listed, but implied) |
| Transportation Validation | Met acceptance criteria | (Standard not explicitly listed) |
| Clinical Transportation | Met acceptance criteria | (Standard not explicitly listed) |
| Mechanical Strength of Plate | Met acceptance criteria | ASTM or internally predetermined criteria |
| Mechanical Strength of Locking Mechanism between Plate and Screw | Met acceptance criteria | ASTM or internally predetermined criteria |
| Handling of System (End User & End Product Test) | Met acceptance criteria | (Standard not explicitly listed, likely internal) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these non-clinical tests typically involve laboratory testing of manufactured devices or materials, not patient data in the conventional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the non-clinical performance and V&V testing described. "Ground truth" in this context refers to clinical outcomes or diagnoses, which were not part of this submission's evidence for efficacy. For mechanical and biocompatibility testing, the "ground truth" is defined by the standards (ISO, ASTM) themselves or internal specifications.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases and their disagreements need to be resolved. The tests described are laboratory-based conformance tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical testing was performed to support this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a physical medical implant (a bone plate) and associated design/manufacturing process, not an algorithm or AI software for diagnosis or analysis. The "Plate Design Software (PDS)" is part of the design process, but its performance wasn't evaluated as a standalone AI diagnostic tool.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is the established acceptance limits defined by international standards (ISO, ASTM) or internal predetermined specifications. For example, a biocompatibility test result must fall within the range deemed safe by ISO 10993, and mechanical strength must exceed certain load thresholds.
8. The Sample Size for the Training Set
Not applicable. The device is a physical implant and manufacturing process. There is no concept of a "training set" as one would have for a machine learning algorithm. The design process for each plate is customized based on patient-specific CT data and surgeon input, but this is not a learning algorithm that requires a "training set" of cases to develop its core function.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device. The design process (CMRP-DP including PDS) relies on established engineering principles, CAD/CAM software, patient-specific imaging data (CT-scan), and surgeon input, rather than a machine learning model trained on a ground-truthed dataset.
§ 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.