(192 days)
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.
The Synthes Patient Specific Cranial/Craniofacial Implant replaces bony voids in the cranial/craniofacial skeleton. The implants are preformed / pre-shaped to fit the anatomy of the patient, will range in size from 10 x 10 mm to 200 x 200 mm, and attach to the native bone using standard Synthes cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm. The Synthes Patient Specific Cranial/Craniofacial Implants are manufactured from CP Titanium and PEEK.
The provided document is a 510(k) summary for the Synthes (USA) Patient Specific Cranial/Craniofacial Implants and does not contain information typically found in a study description of a medical device's performance against acceptance criteria.
Specifically, the document focuses on:
- Identifying the sponsor, device name, classification, and predicate device.
- Describing the device and its intended use.
- Stating the substantial equivalence to a predicate device (an existing, legally marketed device).
- The FDA's letter of clearance stating that the device is substantially equivalent and can be marketed.
- The Indications for Use statement.
There is no information in this document regarding acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert involvement.
To address your request, such information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) application, but it is not summarized in this particular 510(k) summary document.
Therefore, I cannot provide the requested table and details based on the provided text.
§ 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).