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510(k) Data Aggregation
(138 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 and in guiding the marking of bone before cutting. The PROPHECY™ Preoperative Navigation Alignment Guides 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 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.
Wright Medical's PROPHECY INVISION Preoperative Navigation Alignment System (K162795) is being expanded to include patient-specific guides for the INVISION Total Ankle System. Like the predicates PROPHECY INFINITY and PROPHECY INBONE guides, the subject patient-specific guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the reusable instruments, facilitate positioning of INVISION Total Ankle Implants.
I apologize, but the provided text from the FDA 510(k) K170968 does not contain the detailed study information required to answer your request about acceptance criteria and device performance.
The document is a 510(k) summary for a pre-operative navigation system. While it mentions that evaluations were conducted to support safety and efficacy, it only lists the types of evaluations (e.g., "Pre-operative vs Post-operative Analysis of Implant Placement," "Guide Placement Repeatability Inter-surgeon Variability"). It explicitly states "N/A" for clinical evidence ("SUBSTANTIAL EUIVALENCE – CLINICAL EVIDENCE N/A").
To provide the information you've requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, ground truth establishment, etc., I would need access to the full submission or specific study reports that detail the results of these evaluations. This 510(k) summary only provides a high-level overview and states that the device is substantially equivalent based on non-clinical evidence.
Therefore, I cannot populate the table or answer the specific questions about the study design and results from the provided text.
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(141 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 and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® 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 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.
PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.
The provided document does not contain information regarding a specific study with acceptance criteria and a detailed analysis of device performance against those criteria. The document is a 510(k) summary for the PROPHECY® INVISION® Preoperative Navigation Alignment System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.
Therefore, I cannot provide the requested information. The sections concerning sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this document.
The "Design repeatability across design engineers" and "Software validation" mentioned in section 7 ("Substantial Equivalence- Non-Clinical Evidence") are very high-level statements and do not provide the detailed performance metrics, acceptance criteria, or study methodologies that would allow for a comprehensive answer to your request.
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