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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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1. The Zura-EVO System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes.

2. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indical for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs.

3. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

The Zura-EVO Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system. Its function is to acquire ultrasound echo data and display it in B-Mode, or Color Doppler Mode on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an optional electrocardiography (ECG) display feature and support for a 3- lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has measurements and calculations, image storage and review, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The Zura-EVO Imaging System consists of the following major components:

1. Ultrasound Machine: A predicate device ultrasound machine (K102997) 2. Ultrasound Probes

a. ClariTEE Probe: A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes that enables long term use in clinical settings such as the ICU. This probe has predicate coverage under K080223 and K100969.

b. TTE probe SA4-2/24: Transthoracic probe has a predicate coverage under K102997

3. Ultrasound Imaging Software: Ultrasound imaging functions are controlled via the ImaCor Zura software. The Graphical User Interface, which is the piece of software exposed to the user, communicates user inputs to the Ultrasound Imaging Platform which interfaces with the Ultrasound Transducer. The ImaCor Zura software also communicates with the probe directly to monitor the probe's lifespan. Orientation and position of the probe is controlled manually by the user.

The provided document is a 510(k) summary for the Zura-EVO Imaging System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a performance study with acceptance criteria. It mentions non-clinical testing for electrical safety, sterility, aged acceleration testing, and acoustic output testing against specified standards (IEC 60601, ISO 14971, ISO 10993). However, these are general compliance tests for device safety and performance according to harmonized standards, not specific clinical performance metrics with acceptance thresholds typically seen in studies for medical device approval.

Therefore, I cannot extract the requested information from the provided text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test set anaysis.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used for specific clinical assessments.
• Training set sample sizes or how ground truth was established for training data.

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The ImaCor Zura system with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU. for an indwelling time period not to exceed 72 hours. The ImaCor Zura system with ClariTEE probe is not intended for pediatric use

The ImaCor Zura system with ClariTEE probe consists of three main components:

1. Ultrasound Machine: A TEE predicate device optimized for use with ImaCor ClariTEE probe.
2. Ultrasound Probe (ClariTEE formerly known as the Blue Probe in K080223): A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images.
3. Ultrasound Imaging Software: The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37. Latest software version enables two modes of operation; type B and color flow Doppler. The subsequent version cleared for marketing under K080223 enabled type B only.

The ImaCor Zura system with ClariTEE probe, a Transesophageal Echo Imaging System, received 510(k) clearance for software modification. The primary change was the addition of a color flow Doppler mode of operation.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Performance data using a flow phantom demonstrates the effectiveness of the design modification; the addition of a color flow mode of operation to support the assessment of cardiac function."

• Test Set Sample Size: Not specified for the flow phantom. Flow phantom studies typically involve simulating various flow conditions but don't involve human subject sample sizes in the traditional sense.
• Data Provenance: The study was conducted on a "flow phantom," which is a controlled, laboratory-based setup designed to simulate fluid flow. This implies an in-vitro or ex-vivo experimental setting, not human subject data. The country of origin is not specified, but the submission is to the US FDA, so presumably the testing was done in a manner compliant with US regulatory expectations, likely in the US or a country with comparable standards. It is a prospective test specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The performance data was gathered from a "flow phantom" for the new color flow mode. This type of testing typically relies on engineering specifications and physical measurements (e.g., flow velocity, direction accuracy) rather than expert human interpretation to establish ground truth for the device's technical function.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance data cited is from a "flow phantom," which means the "ground truth" for evaluating the function of the color flow mode would be based on the known parameters of the phantom and direct measurements from the device, not on expert adjudication of medical images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document only mentions performance data from a "flow phantom" and a claim of substantial equivalence to predicate devices based on this and other characteristics.

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

Yes, a standalone performance assessment was done for the device's new feature (color flow mode) using a "flow phantom." This is an algorithm-only evaluation in the sense that the device's ability to accurately depict flow was tested independently of human interpretation of clinical images. The data pertains to the technical function of the device itself.

7. The Type of Ground Truth Used

For the specific performance data cited (color flow mode), the ground truth was known physical properties and measurements of the flow phantom. This is typically based on pre-established parameters of the phantom and/or reference measurements from other calibrated equipment, not on expert consensus, pathology, or outcomes data, as those relate more to clinical accuracy studies.

8. The Sample Size for the Training Set

Not applicable to this 510(k) submission. This submission is for modifications to an existing device (software change to add color flow Doppler), not the initial development of an AI algorithm that would require a distinct training set. The "performance data" refers to validation testing, not model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set or an AI algorithm being independently trained in this 510(k) summary. The submission focuses on modifications to an existing, cleared ultrasound system and probe.

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