(129 days)
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
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software Verification | All design outputs meet all specified requirements. | All test results met the acceptance criteria. |
| Software Validation | Software specifications conform to user needs and intended uses. | All test results met the acceptance criteria. |
| Usability Test | The software is safe and effective for the intended users, uses, and use environments. | All test results met the acceptance criteria. |
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.
§ 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.