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510(k) Data Aggregation
(224 days)
Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.
Akunah REFLECT Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The user interface software is connected to an online management system (OMS), and is intended to be used by orthopaedic surgeons as a preoperative planning software for shoulder surgery. The software is intended to allow surgeons to:
- Visualize, measure, reconstruct, and annotate anatomic data,
- Select and position shoulder implant devices,
- . Output pre-surgical planning reports
The software is to be used for adult patients only and should not be used for diagnostic purpose.
The acceptance criteria and study proving the device meets those criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All functional requirements are met across all systems and modules. | Akunah REFLECT met the acceptance criteria stated for all functional verification testing across all systems and modules. |
| Geometric accuracy of virtual models created by the device. | Both Akunah Auto-segmentation and Premorbid Reconstruction demonstrated equivalent accuracy as established by the predicate devices. |
| Accuracy of measurement tools. | Measurement Tools were verified to achieve an acceptable accuracy. |
| Overall validation of the software against user needs (usability). | Usability testing demonstrated the validation of the software on the Desktop for surgical planning. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Software verification and validation testing were performed."
3. Number of Experts and their Qualifications for Ground Truth
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess improvement with AI vs. without AI assistance. The study focuses on verifying the device's functional requirements, geometric accuracy, measurement tool accuracy, and usability.
6. Standalone Performance
The document primarily describes a standalone performance evaluation of the Akunah REFLECT software. It highlights that the software itself met its functional requirements, demonstrated geometric accuracy equivalent to predicate devices, and that its measurement tools achieved acceptable accuracy. Usability testing also validated the software's performance on its own for surgical planning. There is no mention of human-in-the-loop performance being evaluated in this section.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for specific aspects like geometric accuracy or measurement tools. However, for geometric accuracy, it implicitly refers to "accuracy as established by the predicate devices," suggesting a comparison against a known standard or established method from those predicate devices.
8. Sample Size for the Training Set
The document does not provide information about the sample size used for any training set.
9. How Ground Truth for the Training Set Was Established
The document does not provide information about how ground truth was established for any training set.
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(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.
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