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The ATEC Alignment App assists healthcare professionals in viewing, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.

The ATEC Alignment App is intended for use by trained healthcare professionals as a standalone software for viewing, measuring, and storing of x-ray images. The app is a medical device software used to measure spinopelvic parameters from patient x-rays images 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 based on published literature. Clinical judgment and experience are required to properly use the software.

The ATEC Alignment App underwent verification and validation testing to ensure it meets its functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample size used for the test set or the country of origin of the data. However, it indicates that a direct comparison test was conducted using "the same clinically representative images." It does not specify if the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method:
The document does not detail the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document states that a "direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted." However, it does not explicitly describe it as a multi-reader multi-case (MRMC) comparative effectiveness study or provide an effect size for human readers' improvement with AI assistance. The comparison was to evaluate the similarity in performance between the two devices.

6. Standalone Performance:
Yes, a standalone performance assessment was conducted for the ATEC Alignment App. The verification and validation testing confirmed that "the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range."

7. Type of Ground Truth Used:
The type of ground truth used is implied to be based on the "clinically representative images" for which accurate angle measurements and proper display of resultant values were expected. The document mentions that the app's patient parameters and calculations are "based on published literature," which suggests that the ground truth for medical parameters is derived from established medical knowledge.

8. Sample Size for Training Set:
The document does not specify the sample size used for the training set.

9. How Ground Truth for Training Set Was Established:
The document does not explicitly state how the ground truth for the training set was established. However, for the application's core functionality of measuring spiropelvic parameters and calculations, it states that these are "based on published literature." This suggests that the underlying algorithms and expected outcomes are derived from established medical research and clinical guidelines.

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