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The LOGIQ 700 with B-flow is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus.

The LOGIQ 700 with B-flow consists of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. The addition of Bflow to the LOGIQ 700 extends the B mode imaging capability of blood flow, providing the user with enhanced visualization of flow and qualitative assessment.

The GE LOGIQ 700 Diagnostic Ultrasound System with B-flow Modification, as described in the provided documentation, did not undergo specific performance studies with acceptance criteria to prove its effectiveness for the B-flow modification.

Instead, its clearance was based on substantial equivalence to a previously marketed device (GE LOGIQ 700) and adherence to safety standards. The B-flow modification was considered an extension of existing B-mode imaging capabilities, with acoustic output levels equivalent to or less than color Doppler imaging, which was already established in the predicate device.

Therefore, many of the typical categories for AI/ML device studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this case because the device's clearance was not based on such performance studies for the B-flow feature.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. No clinical performance test set was used for the B-flow modification. The clearance was based on substantial equivalence to the predicate device and non-clinical evaluations.

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

• Not applicable. No test set with ground truth established by experts was used for the B-flow modification.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring expert adjudication was used for the B-flow modification.

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 for the B-flow modification. The B-flow modification is an imaging enhancement feature, not an AI-assisted diagnostic tool in the sense of comparing human reader performance with and without AI.

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

• Not applicable. B-flow is an imaging mode on an ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For the B-flow modification, there was no ground truth used in a clinical performance study. The device's safety and effectiveness were established through non-clinical tests (acoustic output, biocompatibility, safety) and comparison to a predicate device.

8. The sample size for the training set:

• Not applicable. This device is an ultrasound imaging system with a new imaging mode (B-flow), not an AI/ML algorithm that requires a "training set" in the conventional sense. The B-flow technology is an implementation of B-mode technology for blood flow visualization.

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

• Not applicable. As above, there was no training set for this device.

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