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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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The ImaCor Zura TEE System 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 TEE System is not intended for pediatric use.

The ImaCor TEE System consists of three main components:

1. Ultrasound Machine: A TFE predicate device optimized for use with ImaCor miniaturized probe,
2. Ultrasound Probe (The "Blue Probe"): 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.

The provided text is a 510(k) summary for the ImaCor Zura TEE System, which indicates it's a submission for marketing clearance based on substantial equivalence to existing predicate devices, not a de novo clearance requiring extensive clinical performance studies. As such, the information you're requesting regarding acceptance criteria and detailed study results is largely not present in this type of document.

The document focuses on demonstrating that the new ImaCor Zura TEE System is "as safe and effective as the predicate devices" by having "the same intended uses and similar indications, technological characteristics, and principles of operation." The "minor technological characteristics" are asserted to "raise no new issues of safety or effectiveness."

However, I can extract the available information and highlight what is not present in this specific 510(k) summary regarding performance studies:

Key Takeaways from the document:

• Basis for Clearance: Substantial Equivalence to predicate devices (Ultrasonix Modulo, Sonosite Ultrasound Diagnostic System, GE Vivid 7). This means specific, quantitative acceptance criteria for this new device's performance are typically not established and proven in the same way they would be for a novel device.
• Performance Data Mentioned: "Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness." It also mentions "preclinical (animal) studies and confirmatory clinical studies." However, no details on their design, sample sizes, methodology, or specific acceptance criteria are provided in this summary.

Here's a breakdown of your requested information based on the provided text, indicating where information is absent (as is common for 510(k) summaries relying on substantial equivalence):

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

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

• Sample Size (Test Set): Not specified in the 510(k) summary. The document mentions "phantom measurement data" and "confirmatory clinical studies" but does not provide details on sample sizes for either.
• Data Provenance: Not specified.

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 specified. This information is typically found in detailed study protocols and reports, which are not part of this 510(k) summary.

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

• Not specified.

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

• Not applicable/mentioned. The device is an ultrasound imaging system ("algorithm only" in the context of image acquisition and processing), not an AI-assisted diagnostic tool for human readers as described in an MRMC study setup. The summary focuses on the physical device's performance compared to predicates.

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

• Yes, implicitly. The "phantom measurement data" evaluates the device directly, demonstrating its standalone effectiveness in acquiring images and measurements, without human interpretation as part of the primary performance metric for substantial equivalence here.

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

• For "phantom measurement data," the ground truth would typically be the known physical characteristics or measurements of the phantom itself.
• For "confirmatory clinical studies," the precise ground truth is not specified, but for a TEE system, it would generally involve comparing images and measurements obtained from the device to established diagnostic criteria or other validated imaging modalities.

8. The sample size for the training set

• Not applicable/specified. This is not an AI/ML algorithm that undergoes a training phase in the conventional sense for a diagnostic output. The "software" component controls standard ultrasound machine functions.

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

• Not applicable/specified. (See #8)

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document states:

• "Performance data demonstrate that the miniaturization of the ImaCor probe and ultrasound transducer relative to standard size probes does not impact safety or effectiveness."
• "Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness."
• "The ImaCor Zura TEE system was also subject to preclinical (animal) studies and confirmatory clinical studies."

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence primarily relies on phantom measurement data showing equivalence to predicate devices, supported by preclinical and clinical studies (details not provided in the summary). The FDA's clearance (K080223) indicates they found this evidence sufficient to establish substantial equivalence based on the device having the "same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices."

It's important to understand that 510(k) submissions, particularly for devices relying on "substantial equivalence," often do not include the same level of detailed clinical trial data and statistical analysis that would be present in a PMA (Premarket Approval) application or a de novo clearance pathway for novel technologies that raise new questions of safety and effectiveness.

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