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Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multi-planar clinical imaging in radiology, fetal, gynecology, small organs (breast, thyroid, testes, etc.), urology, neonatal, surgery, orthopedics, abdominal, oncology (tumor volume assessment) and adult cephalic. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

The BioMediCom SONOReal 3D System, cleared via K994385, K012084 and 020068, is an accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems. The device does not provide diagnostic interpretation and is intended for use by or under the order of a physician. It is used to visualize features that may require closer examination in routine 2D ultrasound diagnostic imaging exams.

The provided 510(k) summary for the BioMediCom SONOReal 3D System does not contain specific information about acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

Here's an analysis of what is available and what is missing:

Key Missing Information:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria. As such, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Ground truth details for test or training sets.
• Training set sample size or how its ground truth was established.

Analysis of Provided Information Relevant to the Request:

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

   • N/A. The document outlines the "Intended Use" (similar functions as the predicate device), the "Device Description," and a "Comparison Chart for Substantial Equivalence" to other BioMediCom and EchoTech devices. The comparison chart focuses on functional capabilities, hardware specifications, and software features, aiming to show that the new device is substantially equivalent to previously cleared devices. It does not present specific performance metrics or acceptance criteria for those metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. No information on a test set (or any study data) is provided. The submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No information on ground truth establishment or experts is provided.

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

   • N/A. No information on adjudication is provided.

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:

   • N/A. This device appears to be an accessory for 3D visualization and measurement, not an AI-based diagnostic tool. No MRMC study is mentioned. The device explicitly states it "does not provide any diagnostic interpretations."

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

   • N/A. No standalone performance study information is provided.

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

   • N/A. No information on ground truth is provided.

8. The sample size for the training set:

   • N/A. No information on a training set is provided.

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

   • N/A. No information on a training set or its ground truth establishment is provided.

Summary:

This 510(k) summary for the BioMediCom SONOReal 3D System focuses entirely on demonstrating substantial equivalence to predicate devices (K980308, K994385, K012084, K020068) by comparing its intended use, hardware, and software features. It is for an "accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems" and explicitly states it "does not provide diagnostic interpretation." Therefore, it does not include the detailed performance study information with acceptance criteria and ground truth establishment that would be expected for a device claiming diagnostic capabilities or significant algorithmic performance. The FDA's clearance is based on this substantial equivalence argument.

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