(90 days)
MEDPOR® Surgical Granule Implants are intended for the augmentation or restoration of contour in the cranial facial area. They are indicated for use where a well formed pocket can be formed for containment, and where, because of the irregularity of the deformity, it is difficult to fill with other shaped implants. This material is intended exclusively for non-load bearing applications.
MEDPOR Surgical Granular Implants are 1.15±0.15 cliameter spheres of porous polye : hylene.
The provided text describes a 510(k) summary for a medical device called "MEDPOR® Surgical Granule Implants." This document details the device's description, its comparison to predicate devices, and its intended use. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as a traditional clinical study report would.
The crucial information about acceptance criteria, performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in the provided 510(k) summary.
A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a clinical trial in the way that would typically be described in response to your request.
The document states:
- "The device of this submission is identical to the previously approved MEDPOR material except for the external dimension of the sphere."
- "The device of this submission is substantially equivalent to the referenced IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers in that both are granular form, with granules being in the 1 mm range, and both are constructed of previously approved, although different, biomaterials."
This indicates that the FDA's clearance (K982040) was based on a demonstration of substantial equivalence rather than a new clinical study with specific acceptance criteria that the device had to meet. Therefore, the details requested are not available in this type of regulatory submission.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).