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The NuVasive® NuvaLine™ Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images at various time points in patient care. The device allows the healthcare professional to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on their mobile device.

The NuVasive NuvaLine Mobile App is a medical device software used to measure spinal pelvic and cervical parameters from an image of patient's x-rays taken with the device's camera. These measured parameters provide a quantifiable way to assess a patient's spinal deformity and correction correlated to health related quality of life (HRQOL) scores.

The NuVasive® NuvaLine™ Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images. The device allows healthcare professionals to perform and review spinal alignment assessments of images using measurement tools on their mobile device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set (number of images or cases). It mentions that "Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images."

The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

3. Number of Experts and their Qualifications for Ground Truth

The document does not mention the number of experts used to establish the ground truth for the test set, nor does it specify their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned. The study performed focuses on the device's accuracy against defined criteria, not against human performance or improvement with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The "Verification testing" described focused solely on the accuracy and functionality of the NuvaLine Mobile App without human-in-the-loop performance. Its ability to accurately measure angles and offsets, display values, and provide alerts was tested directly.

7. Type of Ground Truth Used

The type of ground truth used appears to be based on pre-defined "Software Requirements Specifications." The document states, "Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images, and that these values are displayed properly with correct color-coded alert indications. Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy." This implies that the ground truth for measurements was established against these specified accuracy thresholds, likely using known or precisely measured values on test images, rather than expert consensus, pathology, or outcomes data from actual patients.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established. The focus of the provided text is on nonclinical verification and validation testing of the pre-developed software.

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