(98 days)
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.
The devices of this submission are orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.
This document is a 510(k) summary for a medical device (MEDPOR® Plus Orbital Volume Replacement Implants) and, as such, it does not contain the type of detailed information about acceptance criteria, study design, and performance metrics typically found in clinical trial reports or validation studies for AI/ML devices.
The information provided describes the device, its intended use, and its substantial equivalence to previously cleared devices. It confirms that the device is cleared for marketing but does not include any performance data or clinical study results in the manner requested by your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert qualifications, effect sizes of AI assistance, etc.).
Therefore, I cannot extract the requested information from this document. The prompt asks for details that are not present in this 510(k) summary.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.