(76 days)
Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semi-automatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.
The VIDAR Bone Track System is comprised of three modules: The Pre-Operative Module, the Tracking Module and the Post-Operative Module
In the Pre-Operative Module, the patient's digital x-ray is then loaded into the software, either from the hospital network, via a disk or from a digital scanner. The x-ray image is located in the system using standard digital measuring tools. The physician chooses which orthopedic device to template. The user then utilizes the software tools to overlay pre-loaded digital templates onto the x-ray image to allow for proper prosthetic selection. Once the physician has selected all of the appropriate prosthetic components, the software generates a pick list to allow for easy ordering of parts. This list can be printed out.
The VIDAR Bone Track System allows for tracking of orthopedic devices used during patient surgery. Using a PDA and a bar code reader, the devices' bar codes are scanned. Device manufacturer. device part number, lot number, and serial number are captured.
The VIDAR Bone Track System's Post-Operative Module allows the physician to track migration or other changes to the implant in the bones' structures for a specific patient over time using industry-accepted algorithms. The physician can use measurements include stem dislocation, wear circle cup and wear elliptic cup. Bone Track is not a diagnostic tool. It is to be used by the physician as an assistance tool.
The Vidar Bone Track System Software, a device designed for pre-operative digital implant templating and post-operative tracking of orthopedic implants, underwent "bench testing" to ensure it met its intended performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended for: | All testing demonstrated satisfactory performance of the device. |
| - Pre-operative digital implant templating (selection and ordering of orthopedic implants) | Satisfactory performance |
| - Semi-automatic ordering process (printing a pick list) | Satisfactory performance |
| - Tracking of orthopedic components | Satisfactory performance |
| - Post-operative patient follow-up (tracking migration or changes to implant using industry-accepted algorithms) | Satisfactory performance |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states "Bench testing was performed." It does not specify a distinct "test set" in terms of patient data or images. The testing appears to be focused on the software's functional capabilities rather than its performance on a dataset of patient cases. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a patient dataset is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no specific test set based on patient cases or outcomes is described, there is no mention of experts establishing ground truth or their qualifications. The "bench testing" likely involved internal software validation and verification by the company's development team or independent testers against functional specifications.
4. Adjudication Method for the Test Set:
Given the nature of "bench testing" without a specific patient-based test set, an adjudication method for reconciling expert opinions is not applicable and therefore not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not performed. The document focuses on the device's functional performance and its substantial equivalence to a predicate device, not on its comparative effectiveness with human readers or the effect size of AI-assisted improvements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The description implies that the software's functionality was tested in a standalone manner as part of the "bench testing." However, the device is explicitly intended to be an "assistance tool" for physicians, meaning human-in-the-loop interaction is inherent to its intended use. The performance data provided does not differentiate between standalone algorithmic performance and human-in-the-loop performance.
7. The Type of Ground Truth Used:
For the "bench testing," the "ground truth" would have been the functional specifications and design requirements of the software. Each feature, from digital templating to pick list generation and tracking capabilities, would have been tested against its intended design and expected output. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
The document does not provide information about a training set. The Vidar Bone Track System Software appears to be a rule-based or template-driven system rather than a machine learning model that would require a distinct training set for algorithm development.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned or implied for this device, information on how its ground truth was established is not provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.