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The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

The Embrace™ 3D Ultrasound Tomography System is an easy to use diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. Ultrasound images are acquired using a general purpose ultrasound system capable of B-mode imaging in conjunction with an automatic scanning concave transducer. The acquired images are reconstructed using 3-D visualization software at a separate clinical review workstation.

The Orison Embrace System is an ultrasound tomography system intended for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 1 phantom breast with 12 cystic masses.
• Data Provenance: The 'test set' was a phantom breast, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable, as a phantom breast was used. The 'known number of cystic masses' and their positions serve as the ground truth.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth (number and location of cystic masses) was inherently known due to the nature of the phantom.

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

• MRMC Study Done? No. The study described is a technical verification using a phantom, not a clinical study involving human readers.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done? Yes. The System Verification and Validation Testing seems to be a standalone performance study where the device (Orison Embrace System) was tested on its own to identify known masses in a phantom.

7. Type of Ground Truth Used

• Type of Ground Truth: Known physical characteristics in a phantom model (known number and positions of cystic masses).

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated or detailed in the provided summary. The submission focuses on verification testing rather than algorithm training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not explicitly stated in the provided summary. As this is a 510(k) submission for an ultrasound system, rather than an AI/CADe device, the concept of a separate "training set" with established ground truth in the context of machine learning isn't a primary focus of the non-clinical testing described. The primary "test set" was a phantom.

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