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PIUR tUS Infinity is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.

PIUR tUS Infinity may be used on any adult patient aged 22 and older, independent of gender, linquistic and cultural background, or health status, unless any of the contraindications apply.

The PIUR tUS Infinity acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging.

PIUR tUS Infinity device is not intended for body contact (including skin. mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood),

PIUR tUS Infinity is a computer-aided solution to aid in the diagnostic workflow of thyroid and thyroid nodules, including image documentation, analysis, and reporting. Computer vision and machine learning algorithms are applied to a sequence of ultrasound images of the thyroid that have been acquired by a compatible FDA-cleared ultrasound system. The solution identifies the thyroid lobe and proposes its margins to the user who then can make adjustments to the segmentation and approve the final result. Based on this, a lobe volume is calculated. With additional user input, thyroid nodules can be marked, quantified, and visualized as multiplanar reconstructions or 3D volume renderings. The system provides a user interface for the user to select the five ACR TI-RADS parameters and calculates the ACR TI-RADS level from the user input for each nodule. All proposed results must be verified, adjusted if necessary, and confirmed by the user before they can be added to an automatically generated clinical report.

The Infinity software runs on a stand-alone computer (Infinity Workstation - not part of the medical product) that fulfils the defined minimum requirements. It takes as an input a sequence of ultrasound images that are transmitted from the ultrasound to the Infinity Workstation wirelessly through the Infinity Box. The Infinity Box is a piece of hardware that connects to compatible standard ultrasound systems via digital video output such as HDMI or DVI. It grabs 2D ultrasound images through a video grabber and transfers the images to the Infinity Workstation via Wi-Fi in real-time. In addition, a small Infinity Sensor must be clipped onto the ultrasound transducer using individually designed attachments. An inertial measurement unit (IMU) tracks the orientation of the transducer during the scan and sends this information to the Infinity Workstation via Bluetooth. The Infinity Workstation combines information from the Infinity Box and Sensor to generate tomographic 3D ultrasound volumes on which the abovedescribed image analysis can be performed.

The PIUR tUS Infinity acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions.

The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• ACR TI-RADS Classification Validation: 196 male and female patients.
  • Provenance: US, Europe & Brazil (across multiple ethnicities).
• Individual ACR TI-RADS sub-parameters: A subset of 102 patients (likely from the 196 patient ACR TI-RADS dataset).
• Volume Measurement Validation: The text does not explicitly state the number of cases or patients used for volume measurement validation apart from indicating "against conventional protocol."

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

The text states that the ground truth for performance studies is "annotated data sets labeled by medical specialists" and for the predicate device, "the ROI labeled by a panel of specialists." However, the number and specific qualifications (e.g., "radiologist with 10 years of experience") of these experts are not specified in the provided document for either the subject device or the predicate.

4. Adjudication Method:

The adjudication method (e.g., 2+1, 3+1) for establishing ground truth is not specified in the provided document. The text only mentions "annotated data sets labeled by medical specialists."

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

A full MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance is not explicitly described in the provided text. The performance data focuses on:

• Standalone validation of volume measurements against a conventional protocol.
• Standalone validation of ACR TI-RADS classification against conventional 2D ultrasound.

The device is intended to "assist and support medical professionals" and provides "additional information during image review," with "proposed results that must be verified, adjusted if necessary, and confirmed by the user." This implies a human-in-the-loop system, but the study described does not quantify the improvement of human readers specifically with the AI assistance compared to without it.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, standalone performance was done for several aspects:

• Volume Measurement Validation: The device's volume measurements were validated against a conventional protocol. While a "conventional protocol" likely involves human action, the evaluation of the device's accuracy in producing "volume measurements" and "Lin's Concordance Correlation Coefficient," "Mean Squared Error" implies a standalone assessment of the algorithm's output.
• ACR TI-RADS Classification Validation: The PIUR tUS Infinity's ACR TI-RADS classification was assessed for non-inferiority against conventional 2D ultrasound, which suggests a standalone evaluation of the algorithm's classification output.
• Individual ACR TI-RADS sub-parameters: Performance was assessed for these sub-parameters, again indicating a standalone evaluation of the algorithm's ability to characterize these features.

7. Type of Ground Truth Used:

The ground truth used for performance studies is "annotated data sets labeled by medical specialists." This implies expert consensus or expert-labeled data.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set for the computer vision and machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide any specific information on how the ground truth for the training set was established. It only generally states that the device uses "computer vision and machine learning algorithms" and that "the ground truth to be established for performance studies of the device are annotated data sets labeled by medical specialists." It does not differentiate between training and test set ground truth establishment methodologies.

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