(249 days)
The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).
The 3D Preformed meshes are added to the Universal Mesh system in order to offer a more comprehensive selection of mesh solutions for cranial reconstruction. Simply put, the 3D Preformed meshes are the 1.5/1.7mm Dynamic Mesh predicate design provided in a preformed shape. The 3D Preformed meshes are provided non-sterile in 2 different variations; these meshes are offered in a Symmetrical Preformed mesh and an Anatomically preformed lateral mesh. The Anatomically preformed lateral 3D meshes add a 1.0mm thick mesh option to the portfolio, which was not available with the predicate device.
The provided text describes the Stryker Universal Mesh, a device indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher). The information needed to answer the request is scattered throughout sections V, VI, and VII of the document.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Test / Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity determined using DIN EN 10993-5:2009. | Tests supported the biocompatibility of the device. |
| Performance Bench Testing | Sterilization Validation: Validate sterilization instructions according to internal standard and referenced standards (ISO 14937, ISO 17664, ISO 17665-1&2, AAMI TIR 12, AAMI ST 81, AAMI ST 79). | Method validated. |
| Static Load Max. Defect: Determination of defined load and deformation over maximum defect according to labeling of fixated meshes with bone simulation material. | Acceptance criterion were met, tests were passed. | |
| Static Load (70mm diameter defect): Determination of defined load and deformation over 70mm diameter defect according to labeling of fixated meshes with bone simulation material. Comparison to predicate device tested over same defect. | Acceptance criterion were met, tests were passed. | |
| End User Validation Testing: Surgeon evaluation. | Acceptance criterion was met, test was passed. | |
| Internal Handling Test: Non-trained user evaluation. | Acceptance criterion was met, test was passed. | |
| MR Compatibility: Magnetic Resonance (MR) testing for radiofrequency-induced heating and establishing safety and compatibility in the MR environment, according to FDA guidance (March 22, 2016, and December 11, 2014, respectively). | Stryker Universal mesh will be labeled as MR conditional. | |
| Overall Performance | The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. | All acceptance criteria and standards were met. |
2. Sample size used for the test set and the data provenance:
The document does not specify sample sizes for any of the performance bench tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) for these tests, as these are typically laboratory bench tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "End User Validation Testing" (surgeon evaluation), the document simply states "Surgeon evaluation" but does not specify the number of surgeons or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not provide information on adjudication methods for any of the tests.
5. 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 MRMC comparative effectiveness study was done. This device is a physical implant (mesh), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical implant, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical performance tests (static load, sterilization, MR compatibility), the ground truth is established by meeting defined engineering standards and regulations (e.g., ASTM F67, ISO standards, FDA guidance). For the user validation tests, the 'ground truth' is subjective user (surgeon/non-trained user) evaluation against implicit criteria of usability and fit.
8. The sample size for the training set:
This question is not applicable as the device is a physical implant and not an AI/algorithm-based product that requires a training set.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as above.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).