(167 days)
Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The PROPHECY™ Preoperative Navigation Alignment Guides and Reports are intended for use with Wright's INBONE™, INFINITY™ and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for single use only.
The PROPHECY™ Preoperative Navigation Alignment System is composed of two components:
- . PROPHECY™ Preoperative report
- . PROPHECY™ patient-specific guides
The PROPHECY™ Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and information relevant to the successful implantation of a total ankle replacement. The PROPHECY™ Preoperative Navigation Alignment guides are patient-specific devices that are based on preoperative planning software and assist surgeons in transferring this preoperative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments. The PROPHECY™ patient-specific guides are accompanied by the preoperative report and serve as a template for traditional alignment instrumentation used with Wright Medical's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria for the PROPHECY™ Preoperative Navigation Alignment System.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
Specifically, the document states under "(b)(1). Substantial Equivalence - Non-Clinical Evidence":
- "The following evaluations were conducted to support the safety and effectiveness of the PROPHECY™ Navigation Alignment System changes to the PROPHECY™ Preoperative report: Board Certified Surgeon content, layout and accuracy verification and validation"
- "These evaluations concluded the subject device is substantially equivalent to the predicates and is adequate to perform as intended."
And under "(b)(2). Substantial Equivalence- Clinical Evidence":
- "N/A" (Not Applicable)
This indicates that a formal clinical study with performance metrics against acceptance criteria, as typically seen for novel devices or significant performance claims, was not provided or required for this particular 510(k) submission. The "Board Certified Surgeon content, layout and accuracy verification and validation" seems to be a qualitative assessment for the report's changes, not a quantitative performance study with the details requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, or detailed study methodology because this information is not present in the provided text.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.