(109 days)
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
The MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The proposed MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.
The provided document K140462 describes a Special 510(k) Summary for the MatrixNEURO Preformed Mesh. This submission focuses on medical devices, specifically preformed alterable cranioplasty plates, and therefore the acceptance criteria and study information requested are not applicable in the context of AI/ML-based medical devices or diagnostic software.
The document details the following about the device:
- Device Name: MatrixNEURO Preformed Mesh (part of the MatrixNEURO Cranial Plating System)
- Intended Use: Fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
- Device Description: Precontoured meshes manufactured from grade 2 titanium, designed for use with MatrixNEURO Cranial Plating System screws. They are sterile-packed and intended for single use.
- Comparison to Predicate Device: The proposed preformed meshes have identical indications for use and numerous technological similarities (material, thickness, mesh pattern, screw compatibility, etc.) to the predicate device, the Synthes MatrixNEURO Cranial Plating System (K123723). The primary difference is that the proposed devices are precontoured, while the predicate is provided flat.
- Non-clinical performance data: Non-clinical testing was conducted, including "Load at 2 mm of displacement," "Max Load between 0 and 2 mm displacement," and "Stiffness at 2 mm of displacement." These tests concluded that the mechanical performance of the proposed device is comparable to the predicate.
- Clinical performance data: The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
Therefore, regarding your specific questions for acceptance criteria and study details, based on the provided text, the following applies:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission refers to non-clinical performance data (load, max load, stiffness) and states it's comparable to the predicate but does not provide specific numerical acceptance criteria or detailed performance tables in the provided summary.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Clinical testing was not necessary." The non-clinical performance data would relate to material testing, not human test sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there was no clinical testing requiring ground truth establishment by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there was no clinical testing.
- 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: Not applicable. This is a physical medical device (mesh), not an AI/ML-based diagnostic or assistive technology for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established. For the non-clinical tests, the "ground truth" would be the measured physical properties compared against established engineering standards or the predicate device's properties.
- The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional medical device (implantable mesh) and not for an AI/ML-driven device. Thus, many of the requested details regarding clinical studies, ground truth, and AI performance metrics are not relevant to this submission. The "study" described is a non-clinical mechanical comparison to a predicate device to establish substantial equivalence.
§ 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).