(232 days)
The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.
The provided text details a 510(k) submission for the "OsteoSymbionics Patient-Specific Cranial Implant Device." However, it does not contain any information about a study involving AI or human readers, nor does it provide specific acceptance criteria or performance data for a device leveraging AI.
The submission focuses on establishing substantial equivalence for a physical medical device (a patient-specific cranial implant made of polymethyl methacrylate) based on a change from non-sterile to sterile packaging. The evaluation for this device is based on "comparative analysis of physical properties and biocompatibility through standardized testing" and "sterilization and packaging validations."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI or a "study that proves the device meets the acceptance criteria" in that context.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set sample size, or how ground truth for training was established.
This document is solely about the regulatory clearance of a physical medical implant, not an AI-driven diagnostic or analytical device.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).