(133 days)
The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained Arthrex technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.
The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by Arthrex technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by Arthrex technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
The ArthrexVIP Web Portal is a software device intended for managing imaging information and displaying/editing implant placement and surgical treatment options for shoulder joint replacement.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the ArthrexVIP Web Portal in a typical medical device performance study context (e.g., sensitivity, specificity, accuracy against a gold standard).
Instead, the "acceptance criteria" are implied by the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. The performance is assessed through various software testing methodologies rather than clinical outcomes or diagnostic accuracy.
Implied Acceptance Criteria (based on testing performed):
| Acceptance Criteria Category | Description (as implied by testing) | Reported Device Performance |
|---|---|---|
| Software Functionality | The software must function as intended for uploading, transferring, displaying, and editing imaging information and surgical plans, maintaining data integrity, and allowing for plan approval/modification. Changes from predicate must be correctly integrated. | Successfully passed Software Verification and Validation. |
| Software Quality | The software code must be robust, free of critical defects, and correctly integrated. | Successfully passed Regression Testing, Unit Testing, Code Reviews and Checks, Integration Testing. |
| Dimensional Accuracy | The display/editing of implant placement and surgical treatment options, including new implant models and features, must be dimensionally accurate and consistent with the intended design. | Successfully passed Dimensional Verification. |
| Intended Use Fulfillment | The device fulfills its intended use as a software interface, for transfer of imaging data, and for displaying/editing plans generated by trained Arthrex technicians, for the specified glenoid implant lines, including the added Modular Glenoid System baseplate. | Demonstrated through software testing that the device functions as described for its intended use and expanded implant lines. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the traditional sense of a clinical or imaging dataset. The testing performed is primarily software verification and validation, regression testing, unit testing, code reviews, integration testing, and dimensional verification.
- Test Set: Not applicable in the context of clinical images/data. The "test set" would refer to the various software modules, functions, and simulated data used during the V&V processes.
- Data Provenance: Not applicable. No patient data provenance is mentioned as this is not a device that directly analyzes patient data for diagnostic or treatment recommendations. The "data" being tested are software inputs, outputs, and internal states.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is generally not applicable for this type of software-only device where "ground truth" relates to functional correctness and dimensional accuracy rather than clinical interpretation of medical images. For dimensional verification, engineers or subject matter experts in CAD/imaging might define the "ground truth" for measurements, but the document does not elaborate.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable. Software testing typically involves predefined test cases and expected outcomes. Discrepancies would be logged as bugs and resolved, rather than adjudicated by multiple experts in a consensus-based manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence to the predicate." This device is a software portal for image transfer and display/editing of pre-generated plans, not an AI diagnostic tool or an imaging modality that requires human reader performance evaluation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable in the context of typical AI/CADe/CADx devices. This device is a portal and editing tool; it doesn't have an "algorithm" in the sense of making independent diagnostic or treatment recommendations that would require standalone performance metrics like sensitivity or specificity. Its standalone performance is assessed through its software verification and validation processes (i.e., does it perform its specific functions correctly, reliably, and accurately as a piece of software).
7. Type of Ground Truth Used
For the non-clinical testing:
- Software Verification and Validation, Regression Testing, Unit Testing, Code Reviews, Integration Testing: The ground truth is the software requirements specification and design documentation. The software must perform according to these documented specifications.
- Dimensional Verification: The ground truth would be based on engineering specifications, CAD models, or established measurement standards for the implant models and visualization tools.
8. Sample Size for the Training Set
Not applicable. The ArthrexVIP Web Portal is a software tool for data transfer, display, and editing of pre-generated plans. It does not utilize machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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).