(136 days)
The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).
Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.
The Stryker Facial iD Plating System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.
The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeonapproved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.
The provided document describes the Stryker Facial iD Plating System, a custom-designed maxillofacial plating system. The following information is extracted regarding its acceptance criteria and the studies performed:
- Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 17665-1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Moist Heat) | |
| ISO 14937: General requirements for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices | The results of the steam sterilization validation show that the implants, accessories, and models can be sterilized to a Sterility Assurance Level (SAL) of 10E-6 using the recommended steam sterilization instructions. | |
| Biocompatibility | FDA guidance “Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process” (June 16, 2016) | |
| DIN EN ISO 10993-5: Tests for in vitro cytotoxicity | ||
| ISO 10993-10: Tests for irritation and delayed type hypersensitivity – Kligman Maximization test | ||
| ISO 10993-11: Tests for systemic toxicity – Systemic injection test | ||
| ISO 10993-17: Establishment of allowable limits for leachable substances | ||
| ISO 10993-18: Chemical characterization of materials | Cytotoxicity: No cytotoxic effect. | |
| Sensitization and Intra-cutaneous reactivity: In compliance with ISO 10993-10 guidelines. | ||
| Systemic toxicity: In compliance with ISO 10993-11 guidelines. | ||
| Assessment of allowable limits for leachable substances: No toxicological concern remains; further biological testing not justified. | ||
| Chemical characterization: Per report. | ||
| Mechanical Strength | ASTM F382: Standard specifications and test method for metallic bone plates | |
| ASTM STP 731: Tables for estimating median fatigue limit | The subject device has higher static bending strength and non-inferior fatigue bending properties compared to the reference device. | |
| Cleaning Validation | ANSI/AAMI TRI 30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices | |
| ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) | The subject device is safe to be cleaned as per the recommended cleaning instructions. | |
| Transportation Validation | ASTM D642: Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads | |
| ASTM F1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | The subject device is safe to be shipped as per the recommended shipping instruction. | |
| Compatibility Testing | User need validation lab and engineering rationale | The subject device is compatible with the Stryker Universal fixation system. |
| Software Output Validation | Pre-defined acceptance criteria for the entire software workflow (data transfer, imaging (CT and CBCT), bone model generation, plate design, and additive manufacturing data preparation) | The subject device met all pre-defined acceptance criteria, supporting its substantial equivalence. |
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Sample size used for the test set and the data provenance:
The document focuses on bench testing and validation studies, not clinical studies involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/diagnostic device studies using patient data are not directly applicable here. The "test sets" refer to physical samples (e.g., plates, accessory models) used in engineering and biocompatibility tests. The number of samples for each specific test is not detailed, but it is implied that sufficient samples were tested to meet the respective standards. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies described are bench tests and validation studies for a medical device (bone plate system), not a diagnostic AI device requiring expert-established ground truth from patient data. The "ground truth" for these tests are the established standards and specifications (e.g., ISO, ASTM). -
Adjudication method for the test set:
Not applicable, as no human expert adjudication of patient cases or images is described. The results of the tests were evaluated against predefined standards and criteria. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (bone plating system), not an AI/diagnostic software. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While "Software output validation" was conducted for the design and manufacturing workflow, this is not a standalone performance evaluation of a diagnostic or assistive AI algorithm in the typical sense. It validates the output of the design software, ensuring it accurately translates digital models to manufacturing data. There's no performance metric comparing the algorithm's output to a ground truth established by humans for diagnostic purposes. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For bench testing and validation, the ground truth is based on:- Established engineering standards: e.g., ASTM F382 for metallic bone plates, ASTM STP 731 for fatigue limits, ASTM D642 for compressive resistance, ASTM F1886M for seal integrity, ASTM E2314 for cleaning effectiveness.
- Biocompatibility standards: e.g., ISO 10993 series and FDA guidance.
- Sterilization standards: e.g., ISO 17665-1, ISO 14937.
- Internal design specifications and user requirements: For software output validation and compatibility testing.
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The sample size for the training set:
Not applicable. This device is a physical bone plating system, not an AI model that requires a training set of data. The "patient-specific design" does involve software to design the plates for individual patients, but this is a design workflow, not a machine learning model that learns from a training set in the conventional sense. -
How the ground truth for the training set was established:
Not applicable, as there is no mention of a "training set" for an AI model in this 510(k) submission.
§ 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.