(82 days)
E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.
The provided text describes the e-Ortho Shoulder Software, a web-based surgical planning tool for primary total shoulder replacement. It outlines the device's intended use, its substantial equivalence to a predicate device, and a general overview of performance testing but lacks specific details regarding acceptance criteria, study design, and results.
Here's an analysis based on the provided information, with explicit statements about what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "The result of the validation tests coincides with the expected results for each test case and no test failed." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the e-Ortho Shoulder Software. It vaguely states that accuracy testing was carried out to "guarantee the performance," but no specific results are shared.
| Acceptance Criteria (Missing) | Reported Device Performance (Missing specific metrics) |
|---|---|
| Specific quantitative thresholds for implant sizing accuracy, positioning accuracy, or visualization fidelity. | The validation tests coincided with expected results, and no test failed. Accuracy testing was carried out. |
| Usability metrics (e.g., time to complete a planning task, error rate in planning). | Usability test campaign conducted with multiple surgeons; results coincided with expected results. |
| Software stability and reliability (e.g., uptime, crash rate). | Verification process implemented through multiple test campaigns carried out by various evaluators and environments. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states:
- "The validation process was implemented through a usability test campaign, with critical features requiring validation by multiple surgeons."
- "Additional accuracy testing was carried out to guarantee the performance of e-Ortho."
The exact sample size used for the test set is not specified. We only know that "multiple surgeons" were involved in the usability testing.
The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document mentions "multiple surgeons" for usability testing, but it does not explicitly state how many experts were used to establish the ground truth for any accuracy testing, nor does it detail their qualifications (e.g., years of experience, subspecialty).
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from experts is mentioned or described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted comparing human readers with and without AI assistance. The focus is on the device as a planning tool for surgeons rather than an assistive AI for diagnostic reading. It mentions that "Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan," suggesting a comparison, but no formal MRMC study is detailed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done:
The e-Ortho Shoulder Software is described as an "information tool to assist in the preoperative surgical planning" and states that "the chosen procedure is the responsibility of the Surgeon." It clarifies that an "e-Ortho engineer provides inputs via the e-Ortho software." This suggests that the device operates within a human-in-the-loop workflow, providing tools and visualizations.
While accuracy testing was mentioned, it's not clear if a standalone performance evaluation of the algorithm without human interaction for implant sizing, positioning, etc., was performed and reported. The summary emphasizes its role as an assistive tool for surgeons, with an engineer providing inputs.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any accuracy testing. Given its use for surgical planning, potential ground truth sources could include:
- Expert Consensus: Likely for the "expected results" in validation tests.
- Pathology/Outcomes Data: Not mentioned, but ideal for long-term clinical validation.
- Physical measurements/ Cadaveric studies: Not mentioned.
The specific source of ground truth for accuracy claims is not detailed.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size for the training set used to develop or train the e-Ortho Shoulder Software. As a pre-market submission, such details about model development are often included.
9. How the Ground Truth for the Training Set Was Established:
Similar to question 8, since no information regarding a training set is provided, there is no mention of how the ground truth for any potential training set was established.
§ 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).