(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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).