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Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.

Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.

This document is a 510(k) summary for the Embrace Gel, an ultrasound coupling media. It explicitly states that its function and performance are similar to a predicate device (Aquasonic 100 Ultrasound Trans Gel K802146) and that it is "substantially equivalent".

The document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/software device evaluation (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance).

The FDA's review in this case determined that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This type of submission for a physical medical device (like an ultrasound gel) typically focuses on material safety, physical properties, intended use, and comparison to existing, already-approved devices, rather than a clinical performance study with statistical endpoints as would be required for a diagnostic AI algorithm.

Therefore, I cannot provide the requested information from the given text as it is not present.

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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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