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The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.

SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 consisting of SonoCiné Image Acquisition Station Model 100 and SonoCiné Image Reading Station Model 100.

The SonoCiné Image Acquisition Station Model 100 is a probe guiding adjunct to ultrasound systems which have been previously cleared by FDA. The SonoCiné Image Acquisition Station Model 100 uses a servo motor guided arm to control the speed and direction of the ultrasound transducer during breast scanning examinations. In addition, the SonoCiné Image Acquisition Station Model 100 contains a computer which interfaces to the video output of ultrasound system to record and store, electronically, the ultrasound images at reqular time intervals.

The SonoCiné Image Reading Station Model 100 is a software product intended to operate on a personal computer with minimum performance configurations. The SonoCiné Image Reading Station Model 100 is a software product intended to allow after-the-fact review of the images obtained and stored by the SonoCiné Image Acquisition Station Model 100.

Here's a breakdown of the acceptance criteria and study information for the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes Design Validation Tests as the primary method to demonstrate the device meets its performance requirements. The specific acceptance criteria and reported performance are as follows:

Note: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) that were met through a clinical study involving human patients. The validation test focused on the ability to identify masses in a phantom.

Study Details

Based on the provided text, the primary "study" proving the device meets acceptance criteria is a non-clinical phantom study.

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

   • Sample Size: 1 breast phantom with 10 masses.
   • Data Provenance: Not applicable as it was a non-clinical phantom study. There is no mention of country of origin or whether it was retrospective or prospective data from human subjects.

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

   • Not applicable. The ground truth for the test set (phantom) would have been the known locations and presence of the 10 masses designed into the phantom. No human experts were required to establish this.

3. Adjudication Method for the Test Set:

   • Not applicable. As the ground truth was inherent in the phantom design, no adjudication among experts was needed. The testing simply verified if the device could identify the pre-defined masses.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on intended use, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, supported by non-clinical phantom testing. There is no mention of comparing human reader performance with and without AI assistance.

5. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

   • Yes, a standalone (algorithm/device only) test was performed on the phantom. The "System Validation Testing" was performed on the device itself to identify the masses within the phantom, without explicit mention of a human-in-the-loop for this specific test.

6. The Type of Ground Truth Used:

   • Known physical properties/design of the phantom. For the system validation test, the ground truth was the 10 randomly positioned masses within the breast phantom.

7. The Sample Size for the Training Set:

   • Not applicable. The document does not describe the use of an algorithm that would require a "training set" in the context of machine learning or AI. This device appears to be an imaging system that uses servo motors to guide an ultrasound transducer and software for image review, rather than an AI-driven diagnostic tool.

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

   • Not applicable, as no training set is described.

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