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The 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 the 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 three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Preoperative Navigation Alignment guides are patient-specific devices that are designed based on preoperative planning software and assist surgeons in transferring their preoperative plan to surgery by guiding the marking of bone and/or guiding surgical instruments.

The Prophecy® 3D Planner software is a web-based application. The user interface software is intended to be used by orthopedic surgeons, as a preoperative planning and intraoperative viewing software for total ankle replacement surgery.

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 offers relevant information for a successful total ankle replacement surgery.

The Prophecy® Preoperative Navigation Alignment System is compatible with the Inbone™, InfinityTM, and Invision™ Total Ankle Systems.

The 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 the 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.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for the software verification, validation, or usability tests. It only states that the testing was conducted "in-house." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The study is focused on software verification, validation, and usability for a surgical planning system, not on diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method

Not applicable. This type of testing (software V&V, usability) does not typically involve adjudication methods like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission states that "Clinical testing was not necessary for the determination of substantial equivalence."

6. Standalone Performance (Algorithm Only)

The testing described (software verification, validation, and usability) evaluates the performance of the software components of the device, which would include the algorithm's functionality. However, it's not explicitly stated as a standalone "algorithm only" performance study in the context of comparative effectiveness or diagnostic accuracy. The Prophecy® 3D Planner software allows surgeons to modify implant type, size, and orientation, indicating an interaction with a human user.

7. Type of Ground Truth

For software verification and validation, ground truth would be defined by the design requirements and functional specifications. For usability testing, ground truth would involve evaluating whether the software performs as expected for the intended users and uses, likely based on pre-defined tasks and performance metrics. Pathology or outcomes data are not applicable to the described non-clinical tests.

8. Sample Size for Training Set

Not applicable. This document describes testing for a device that involves software for surgical planning and patient-specific guides generation, not a machine learning model that requires a training set in the traditional sense for diagnostic or predictive tasks.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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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.

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