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The ImaCor Zura Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging using the ImaCor ClariTEE probe. (Cardiac, TEE)

The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals.

It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.

The ImaCor Zura Handheld ZHH-010 is a portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial offthe-shelf (COTS) Android™ device. The scanner is Bluetooth and Wi-Fi- based, communicating with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The ImaCor Zura Handheld ZHH-010 houses a battery and internal power supplies, multichannel beamformer, pre-scan converter and Wi-Fi components. The battery is removable and comes with a separate charger.

The system is a transportable (handheld) ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. The ImaCor Zura Handheld ZHH-010 is not to be used in a fixed- or rotary-winged air ambulance.

Piezoelectric material in the system's transducer (ClariTEE probe) transmits high frequency, non-ionizing sound waves to the designated cardiac region of the body and converts the subsequent echoes detected into electronic signals to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external Android viewing device on which the image can be displayed. Communication between the scanner and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The ImaCor Zura Handheld ZHH-010 product components include:

1. Software: SOUP Imaging App for Android
2. Transducers/Scanners: ImaCor ClariTEE probe (TEE probe);
3. Accessories: ImaCor Battery (Li-ion); ImaCor Battery Charger; ImaCor Fan; Medical Power Supply (off-the-shelf power adaptor from GlobTek, Inc.; Model Number WR9QA3200USBNMEDR6B; approved in the US).

The provided document is a 510(k) premarket notification for the ImaCor Zura Handheld ZHH-010, an ultrasound imaging system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Clarius Ultrasound Scanner Model C3HD) and a reference device (ImaCor Zura TEE System with ClariTEE probe).

Crucially, the document states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." This means that there was no clinical study conducted to prove the device met specific performance acceptance criteria for diagnostic accuracy, as is common for AI/ML-driven devices. Instead, the focus was on demonstrating that the new device, primarily an OEM modification with a tethered probe, performs similarly in terms of safety and technical specifications to existing cleared devices.

Therefore, many of the requested points regarding acceptance criteria and performance studies for an AI/ML device (e.g., effect size of human readers with AI assistance, standalone algorithm performance, ground truth establishment) cannot be answered from this document because such a study was not required or performed for this specific 510(k) clearance.

However, based on the information provided, we can infer the acceptance criteria for this type of submission were related to technical and safety standards compliance and demonstration of substantial equivalence to predicate devices.

Here's an attempt to address the points based on what is available in the document, and explicitly stating what is not available:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission didn't involve a clinical performance study with accuracy metrics, the "acceptance criteria" were primarily about meeting established safety and performance standards for ultrasound devices and demonstrating functional equivalence to predicate devices.

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

• Not applicable / Not provided. The document explicitly states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." Therefore, there was no clinical "test set" in the sense of patient imaging data used to assess diagnostic performance. Non-clinical performance tests were conducted on the device itself against standards.

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)

• Not applicable / Not provided. As no clinical performance study was conducted to establish diagnostic accuracy, there was no need for experts to establish ground truth from patient data.

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

• Not applicable / Not provided. No test set was used for diagnostic performance evaluation.

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. The document clearly states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool leveraging machine learning to "improve" human reader performance.

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

• No. This is a hardware/software system for direct human use in imaging, not a standalone AI algorithm.

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

• Not applicable / Not provided. For the purpose of this 510(k), the "ground truth" was more related to the established specifications and performance of the predicate device and relevant international standards.

8. The sample size for the training set

• Not applicable / Not provided. This device is a direct imaging system, and the submission is not for a new AI/ML algorithm that would undergo training on a "training set" of images to learn to perform a diagnostic task. The software is described as "SOUP Imaging App for Android" and "developed by the original manufacturer with no changes made by ImaCor."

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

• Not applicable / Not provided. See point 8.

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