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The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The provided 510(k) summary for the VPan Module to the TechnosMP Ultrasound Imaging System does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial with performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative image quality scores). It relies on a comparison to a predicate device.

The "Comparison Chart for Substantial Equivalence" serves as the primary "acceptance criteria" by showing the new device functions similarly to the predicate.

Reported Device Performance: The document states that the VPan Module (the subject device) "provides panoramic, wide field-of-view images for easier orientation of anatomy and pathology." The implicit performance is that it performs these functions equivalently to the predicate device. No quantitative performance metrics are provided.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a test set or data provenance for a performance study. Clinical data is not typically required for 510(k) submissions that demonstrate substantial equivalence through comparison to predicate devices, especially for devices like this that are modifications or additions to existing ultrasound systems. The focus is on technical characteristics and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

Not applicable. No ground truth establishment for a test set is described as there isn't a performance study evaluating diagnostic capabilities against a reference standard.

4. Adjudication Method for the Test Set

Not applicable. No test set or independent adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound imaging module, not an AI or CAD (Computer-Aided Detection) system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an imaging module, not an algorithm, so standalone performance is not relevant in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no performance study described that would require establishing a ground truth. The submission relies on demonstrating the new module's technical similarity and equivalent intended use to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is an ultrasound imaging module, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set mentioned or implied.

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