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The QT Ultrasound Breast Scanner - 1 is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (Breast) - Reflection, Transmission (Speed of Sound). QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams.

The QT Ultrasound Breast Scanner - 1 is an automated software-controlled ultrasonic imaging system that performs a standardized scan of the whole breast. The OT Ultrasound Breast Scanner - 1 is comprised of a Patient Scanning System, Operator Console and Viewer Console.

The Patient Scanning System consists of a patient support table, scan tank, water management system, ultrasound transducer arrays and all associated image processing electronics. The scan tank is centered below a patient's breast and contains the ultrasound transducer arrays. The transducer arrays include a set of three reflection transducers that transmit pulsed ultrasound plane waves into targeted tissues using the water bath in the scan tank as a coupling medium. An additional transmitter and receiver array pair collect the ultrasound energy to provide speed of sound values.

During scanning, a patient lies prone on the examination table with the breast suspended in a warm water bath maintained near skin temperature. Images are automatically acquired on a pendant breast positioned with the nipple as a point of reference. The transducer arrays rotate about a vertical axis to circle the breast in the coronal plane. The array is then translated vertically, and the scanning process is repeated until the entire breast is scanned, allowing B-scan images to be constructively combined into tomographic, speed of sound and reflection ultrasound images.

The QT Ultrasound Breast Scanner – 1 outputs the images to the QTviewer™ which allows the images to be stored until they are reviewed on a Viewer Console. Coronal, axial and sagittal images are generated for review by the radiologist. Speed of sound images may be queried by the Probe and Region of Interest (ROI) tools provided in the Viewer Console. These tools provide speed of sound values in meters/sec. to aid in diagnostic evaluation of the breast.

This document describes a Special 510(k) submission (K182213) for a modified QT Ultrasound Breast Scanner - 1. The key takeaway is that no clinical study was performed or required for this specific submission because the device is a modification of a previously cleared device (K162372) and the modifications are limited to software updates (QTviewer Software Module). The manufacturer asserts that these software changes do not raise new questions of safety or effectiveness. Therefore, the response will reflect the absence of clinical performance data for this particular submission.

Here's the breakdown based on your requested information, acknowledging the limitations due to the nature of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) for software modifications and does not involve a clinical performance study, there are no specific clinical acceptance criteria or reported device performance in terms of clinical accuracy or effectiveness. The acceptance criteria for this submission were primarily focused on demonstrating that the software modifications did not adversely affect the safety or effectiveness of the previously cleared device, and that the device still meets its design specifications.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size: Not applicable. No clinical test set with patient data was used for this Special 510(k) submission as it focuses on software modifications and non-clinical testing.
• Data Provenance: Not applicable. The testing primarily involved internal software verification and validation, and usability testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. As no clinical test set with patient data was used, no experts were needed to establish ground truth in a clinical context. Usability testing involved users, but not "experts" establishing ground truth in the clinical sense.

4. Adjudication method for the test set

• Not applicable. There was no clinical test set requiring adjudication.

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

• No. An MRMC comparative effectiveness study was not performed. This submission is for a modified ultrasound scanner, and the modifications are software updates to the viewing module, not the introduction of AI for interpretation assistance.

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

• Not applicable. This device is an imaging system, not an AI algorithm for standalone interpretation. The modifications are to the viewing software.

7. The type of ground truth used

• For the software verification and validation, the "ground truth" was the defined software requirements and design specifications. For the usability testing, the ground truth was user requirements. No clinical ground truth (e.g., pathology, outcomes data) was used or required for this specific submission as no clinical performance was being evaluated.

8. The sample size for the training set

• Not applicable. As this submission describes modifications to existing viewing software and not a new machine learning algorithm, there was no "training set" in the context of AI/ML development.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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