(122 days)
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 12 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial (craniofacial region is defined as the orbital rim, zygoma, and adjacent bone) patient specific implants based on CT data and surgeon input. This traditional 510(k) is submitted to add an additional indication for use to augment and/or restore soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
This document, a 510(k) Summary for the Stryker PEEK Customized Cranial Implant Kit, outlines the device's indications for use and compares it to a predicate device. However, it explicitly states that biocompatibility testing, performance bench testing, animal testing, and clinical testing were NOT required as a basis for substantial equivalence for the new indication for use being sought in this submission (K153248).
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for a study proving the device meets acceptance criteria, cannot be provided from this document.
The document explains that substantial equivalence for the new indication (augmentation and/or restoration of soft tissue deformities, specifically PTH) was based on a literature review and case history to demonstrate that the expanded indication does not raise new questions of safety or effectiveness compared to the predicate device.
Specifically, the document states:
- "A literature review was performed to identify relevant clinical literature with applicable data to show that, when compared to the predicate device, the new Indication for use added to the subject device does not raise new questions of safety or effectiveness. The results of this review provides evidence of this fact." (Page 4)
- "To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history. A summary of the clinical literature verifies that PTH reflects a deficiency in the bulk of the temporalis muscle or overlying temporal fat pad. Surgical results with augmented implant designs have been published upon and shown to be clinically successful in addressing PTH." (Page 5)
In summary, this document does not contain a study with acceptance criteria and a test performed against them. It relies on a literature review and case history to support the expanded indications for use.
§ 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).