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VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in identifying the origin of cardiac arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images combined with standard ECG recordings and electrode placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) electrodes placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a patient specific, three-dimensional (3D) anatomy of the endocardial and epicardial surfaces of the heart. A 3D photograph of the patient's chest with the precise ECG lead locations and positioning patches that were used to acquire the ECG is merged with the torso and heart model to determine the spatial relationship between them. From these data, the system uses a mathematical algorithm to assimilate the geometrical information and transform the measured body surface signals into epicardial signals by solving the cardiac inverse problem. VIVO software creates, displays, and stores a cardiac activation map that displays the site of earliest activation of ventricular arrhythmias.

The VIVO system includes an off the shelf laptop computer and a handheld 3D camera. The preloaded software takes data from previously acquired cardiac and thoracic images, standard 12-lead ECG recording made during an arrhythmia and 3D picture of the ECG leads and positioning patches. This information, obtained prior to the procedure, can be used during pre-procedure planning by a qualified physician.

The provided text details the 510(k) premarket notification for the VIVO™ Model 9002 system (K200313), which is a pre-procedure planning tool for identifying the origin of cardiac arrhythmias. However, the document does not contain explicit acceptance criteria or detailed results of a study proving the device meets specific performance criteria related to its accuracy in identifying arrhythmia origins.

Instead, the performance data section focuses on verification and validation (V&V) testing to confirm that the VIVO Model 9002 system operates as intended and is substantially equivalent to its predicate device (VIVO Model 9001). The "Performance Data" section primarily describes:

• System Testing: Verification that the assembled VIVO Model 9002 device met specified requirements, including VIVO software access, laptop PC function, and 3D camera function (with positioning patches).
• Bench Testing: Confirmation of the system's ability to collect the position of patches and electrodes.
• User Validation Testing: Evaluation of the usability of the new software workflow and the user's ability to generate a 3D model. This included identifying critical tasks and collecting pass/fail data.
• Biocompatibility Testing: For positioning patches, conforming to ISO 10993-1.
• Shelf Life Testing: For positioning patches (one-year shelf life).

The document explicitly states: "Clinical Testing Not required to demonstrate substantial equivalence to the predicate device." This implies that the FDA determined that extensive clinical performance data for arrhythmia localization was not necessary for the 510(k) clearance, likely due to the device's classification and its claimed substantial equivalence to a previously cleared device.

Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy in identifying arrhythmia origin), sample sizes for test sets, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in the provided 510(k) summary. The study described is primarily a non-clinical performance study focusing on system functionality, usability, and equivalence to the predicate, rather than a clinical accuracy or comparative effectiveness study for the core diagnostic claim.

Given the limitations of the provided text, I will answer the questions based on the information available and explicitly state when information is not present.

Acceptance Criteria and Device Performance Study (Based on Provided Document)

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

As explicitly stated, the performance testing focused on system verification and validation, demonstrating that the device met system requirements, component operation, and performance, and that the usability was acceptable. There are no quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia origin localization) provided in this specific document.

Note: The document does not provide performance data or acceptance criteria related to accuracy of arrhythmia localization, as this was not a required part of the substantial equivalence determination according to the stated "Clinical Testing Not required" clause.

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

• Sample Size for Test Set: Not explicitly stated for performance testing. The text refers to "System Testing," "Bench testing," and "User Validation Testing" but does not quantify the number of cases or users involved in these tests.
• Data Provenance: Not specified. The testing described appears to be internal verification and validation, possibly synthetic data for bench tests or internal users for usability tests, rather than clinical patient data. The clinical testing was explicitly stated as "Not required."

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 as the described "Performance Data" section focuses on system functionality and usability, not diagnostic accuracy requiring expert-established ground truth for a clinical test set. The document states "Clinical Testing Not required".

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

• Not applicable as the described "Performance Data" section focuses on system functionality and usability, not diagnostic accuracy requiring adjudication for a clinical test set.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed or submitted for this 510(k). The document explicitly states, "Clinical Testing Not required to demonstrate substantial equivalence to the predicate device." The VIVO system is described as a "pre-procedure planning tool" and not an AI-assisted diagnostic tool that would typically warrant such a study for this type of clearance.

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

• The document describes the VIVO system as a "pre-procedure planning tool that provides a 3D mapping of the heart to aid in identifying the origin of cardiac arrhythmias prior to electrophysiology procedures." The "Analysis algorithm is identical to VIVO Model 9001." However, the performance data section focuses on system and software functionality and usability, not the standalone algorithmic accuracy of "identifying the origin of cardiac arrhythmias." While the algorithm is a core component, a specific standalone performance study measuring its diagnostic accuracy (e.g., against some defined ground truth) is not detailed. The clearance relies on substantial equivalence primarily due to the functional and technical similarities to the predicate, and usability enhancements.

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

• For the reported performance testing (system and user validation), the "ground truth" was internal design specifications and defined usability task completion criteria. For the purpose of "identifying the origin of cardiac arrhythmias," the document implies that this is a physician's analysis, and no external ground truth (e.g., confirmed ablation success, invasive mapping, pathology) was used as part of this 510(k)'s "Performance Data."

8. The sample size for the training set

• The document does not discuss a training set or the development of an AI/machine learning model. While the system uses "mathematical algorithms to assimilate the geometrical information and transform the measured body surface signals into epicardial signals," there is no indication that this involves trainable components requiring a distinct "training set" in the machine learning sense. The "Analysis algorithm is identical to VIVO Model 9001," implying it's a fixed, established algorithm rather than a newly trained one.

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

• Not applicable, as a training set for an AI/machine learning model is not discussed in the document.

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VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal ventricular arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images and standard ECG recordings and lead (electrode) placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) sensors placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a detailed, three-dimensional (3D) anatomy of the endocardial and epicardial surface of the heart. A 3D photograph of the patient's chest with the precise ECG lead positions used to acquire the 12 lead ECG is merged with the torso and heart model to determine the spatial relationship between the electrodes and the heart. From these data, the system uses a mathematical algorithm to use the geometrical information to transform the measured body surface potentials into myocardial potentials via solving the cardiac inverse problem. The VIVO system uses an off the shelf laptop computer and a handheld 3D camera. The VIVO software creates, displays, and stores a cardiac model that displays the site of earliest activation of ventricular arrhythmias.

VIVO software is comprised of two software applications, VIVO Anatomy and VIVO Analysis.

VIVO Anatomy merges the imported cardiac MR/CT image data with a model to create a heart and torso model representative of a patient's specific anatomy. The MR/CT image data must be imported via a DVD containing the images in DICOM format (Note: VIVO does not have a web interface). The DICOM image is then overlayed on top of one of a number of preloaded anatomical models to fine tune the preloaded model. The model that best matches the patient's anatomical profile is chosen. Specific cardiac structures and tissues are identified by the User within the images to better match the patient anatomy. An outline of the chambers and tissue walls is automatically created by VIVO which is then finetuned by the User for a precise match to the patient's anatomy.

VIVO Analysis combines the heart and torso model generated from VIVO Anatomy with ECG data, and a 3D photograph of the ECG lead placement to identify the location of the arrhythmia foci. After ECG leads are placed on the patient, a 3D photograph of the patient's chest is captured to accurately record lead locations. Arrhythmic ECG signals are recorded from these electrodes and imported into the VIVO software. This data is combined and a mathematical algorithm is used create a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: 45 patients
• Data Provenance: Prospective, non-randomized study conducted at 6 US centers.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, it indicates that the VIVO localization was compared with "CARTO localization", implying that CARTO mapping results were used as the reference standard (ground truth), which would typically be interpreted by electrophysiologists.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method. The comparison states "VIVO localization... agreed (was a match) with the CARTO localization," suggesting a direct comparison without a complex adjudication process between multiple readers.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the VIVO system compared to CARTO localization.

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

Yes, a standalone assessment of the VIVO system's performance was done. The study "assessed VIVO's ability to accurately determine the anatomical location of a particular ventricular origin," and its localization was directly compared to CARTO results. While physicians analyze the VIVO output, the study evaluates the accuracy of the system itself in producing the localization.

7. The type of ground truth used:

The ground truth used was CARTO localization. CARTO is an established electroanatomical mapping system used to create 3D maps of the heart and identify arrhythmia origins.

8. The sample size for the training set:

The document does not provide information regarding the sample size for the training set. The clinical study described is for validation/performance assessment.

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

The document does not provide information on how the ground truth for any training set was established. The clinical study described focuses on the performance of the finished device.

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