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The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

The Viyo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The Vivo 45 LS can be operated in the following combinations of ventilation and breath modes:

• PSV-Pressure Support Ventilation
• PSV(TgV)-Pressure Support Ventilation with Target Volume ●
• PCV-Pressure Controlled Ventilation
• PCV(TgV)-Pressure Controlled Ventilation with Target Volume ●
• PCV(A)-Assisted Pressure Controlled Ventilation
• PCV(A+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
• PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
• PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
• . VCV-Volume Controlled Ventilation
• VCV(A)-Assisted Volume Controlled Ventilation
• VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
• VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
• CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy

High flow nasal therapy (HFNT) may be prescribed for spontaneously breathing patients undergoing non-invasive ventilatory therapy using a small, medium or large nasal cannula interface. The user may prescribe a flow rate setting in the range of 4 to 60 liters per minute. It is recommended to use an external humidifier, the Fisher & Paykel MR 850, during HFNT, due to possibly higher humidification output requirements of the patient. The Vivo 45 LS automatically disables the internal humidifier when the HFNT feature is being used.

Conditioning of the breathing air's temperature and humidity level may be prescribed for noninvasively ventilated patients using the integrated humidifier and heated wire patient circuit of the Vivo 45 LS at the clinician's discretion to enhance patient comfort and compliance. The humidification function is enabled by the Vivo 45 LS only when the device is powered by AC Mains and is automatically disabled including power to the heating plate when the device is powered by battery. The humidifier heating level can be selected by the user by setting the heating level (1-5) on the device user interface.

The Vivo 45 LS provides the user with available settings that determine the power delivered to the heater wire. This setting is in terms of a patient-end temperature in the range of 16 to 30° C. The heated wire patient circuit contains a temperature sensor located at the patient connection port, and the firmware of the Vivo 45 LS continuously monitors the temperature and automatically adjusts the power delivered to the heater wire to maintain the temperature at the user set point.

The provided text is a 510(k) summary for the Breas Medical AB Vivo 45 LS ventilator. It details the device's characteristics, comparisons to predicate devices, and performance data to demonstrate substantial equivalence to legally marketed devices.

However, the document does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets a specific acceptance criteria table. Instead, it discusses:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the modified Vivo 45 LS is substantially equivalent to a previously cleared predicate device (K193586) and reference devices. This is done by showing similar intended use, technological characteristics, and performance data.
• Performance Testing: It lists various performance tests conducted according to relevant standards (e.g., electrical safety, EMC, usability, alarm systems, biocompatibility, accuracy of controls and monitored values, cybersecurity, software verification/validation, human factors). The text states that "all tests passed" or "met all specifications," implying that the device did meet internal acceptance criteria for these tests, but these specific criteria are not explicitly detailed in a table for most categories.
• Human Factors Study: A summative human factors study was performed to assess user safety and effectiveness, including specific findings related to critical tasks and risk mitigation.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or MRMC studies in the manner you've outlined, as that level of detail is not present for quantitative performance metrics tied to specific acceptance thresholds.

Based on the provided text, here's what can be extracted regarding the types of studies and the nature of the performance assessment:

The document focuses on demonstrating substantial equivalence for a modified medical device. This is a regulatory pathway where the new device is shown to be as safe and effective as a legally marketed predicate device. The "proof" is largely comparative and based on meeting recognized standards and internal specifications, rather than a standalone clinical trial proving a specific performance target against a pre-defined acceptance criterion.

Here's a breakdown of the information that is available or implicitly stated, addressing your points where possible, and noting what is missing:

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

   • Not explicitly provided in the document for the overall device.
   • The document presents tables comparing the subject device's features and performance specifications (e.g., accuracy of controls, accuracy of monitored values, alarm settings) to the predicate device. It then broadly states that "testing confirmed that the Vivo 45 LS meets its accuracy specifications," implying acceptance criteria were met but not detailing them in a distinct "acceptance criteria vs. reported performance" table.
   • For example, under "Accuracy of Controls," it lists "Inspiratory Pressure: max of ±0.5cmH2O, ±5%" for both subject and predicate device, and notes "Same." This implies this was an acceptance criterion, and performance matched it. However, actual reported device performance (e.g., "The device demonstrated an inspiratory pressure accuracy of ±0.3cmH2O, ±4%") is not provided.

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

   • Human Factors Testing: The only specific sample size mentioned is for the summative human factors study:
     • Sample Size: 15 Respiratory Therapists (RTs), 15 Registered Nurses (RNs), and 15 Lay Caregivers (LCGs). Total = 45 participants.
     • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's a "summative human factors testing" which is typically prospective.

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

   • Not applicable directly in the context of setting "ground truth" for diagnostic accuracy, as this is a ventilator, not a diagnostic imaging device.
   • For Human Factors: The experts involved would be the human factors professionals designing and performing the study, and potentially clinicians involved in scenario review. Their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

   • Not applicable directly for diagnostic accuracy.
   • For Human Factors: Errors and difficulties observed during the human factors study were subject to "root cause analysis." The method of adjudication for identifying these errors or classifying them (e.g., by multiple observers) is 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 addressed. This type of study (MRMC for AI assistance) is relevant for AI-powered diagnostic aids, not for the core function of a mechanical ventilator.
   • The "human factors testing" evaluated user interaction and safety with the device, not the device's diagnostic performance in assisting human "readers."

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

   • Not detailed for the AI (if any). The device is a ventilator, a mechanical and software-controlled device. Its "standalone performance" refers to its ability to meet specifications for delivering ventilation, controlling parameters, and managing alarms.
   • The document states: "Performance testing included testing to the standards and procedures listed below:" and then lists many standards, followed by "The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device." and "Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications." This implies rigorous standalone testing.

7. The type of ground truth used:

   • For ventilator performance (pressure, flow, volume, etc.): "Ground truth" would be established by reference measurement devices/standards in a laboratory setting. The specific reference standards used are implied to be those within the listed IEC and ISO standards that the device was tested against.
   • For Biocompatibility: "Ground truth" is established by laboratory analyses against specified chemical and biological endpoints (e.g., absence of VOCs above threshold, non-cytotoxic results, non-sensitizing results), based on ISO standards.
   • For Human Factors: "Ground truth" for safe and effective use is established by the pre-defined critical tasks that users must perform successfully without errors that lead to harm. "Root cause analysis" was performed on observed errors.

8. The sample size for the training set:

   • Not applicable. This document describes the testing and regulatory submission for a physical medical device (ventilator) with integrated software, not an AI/ML algorithm that undergoes "training."

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

   • Not applicable for the same reason as above.

In summary, while the document confirms rigorous testing against various standards and specifications, it does not present the specific acceptance criteria and detailed reported performance in a structured comparative table as requested for an AI/ML driven diagnostic device. The focus is on demonstrating compliance with regulatory standards and substantial equivalence to a predicate device, rather than proving a statistical performance metric against clinical ground truth for a novel AI indication.

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Ask a specific question about this device

The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (1 1bs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

The Vivo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The provided FDA 510(k) summary (K193586) describes the Breas Medical AB Vivo 45 LS ventilator. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing an independent clinical study with acceptance criteria in the way a de novo device might.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics for the device for a standalone clinical study. Instead, performance testing focused on verifying conformance with requirements specifications and applicable standards, and comparative testing with predicate devices. The acceptance criteria are implicitly tied to meeting these standards and demonstrating substantial equivalence.

Here's an attempt to infer and summarize the performance goals and how they were met based on the provided text:

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

The document does not specify a "test set" in terms of patient data or clinical samples. The performance testing described is primarily bench testing against engineering specifications and industry standards, and comparative testing against predicate devices (Vivo 60 and Trilogy Evo). Therefore, concepts like country of origin or retrospective/prospective data provenance are not applicable in the context of this device's testing as described.

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

Not applicable in the typical sense. The "ground truth" for the engineering performance tests is derived from established engineering principles, international standards, and the performance characteristics of the predicate devices.

However, for summative usability/human factors testing, the document mentions the involvement of:

• Respiratory therapists
• Registered nurses
• Lay caregivers

Their collective feedback and performance in simulated use scenarios would have served as the "ground truth" for assessing the device's usability and human factors safety. The exact number of each type of professional is not specified.

4. Adjudication method for the test set

Not explicitly stated for the engineering and comparative tests. The passing of tests against specifications and standards implies adherence to predefined pass/fail criteria. For the usability testing, "was found to be safe and effective" suggests a consensus or evaluation against usability requirements, but a specific adjudication method (e.g., 2+1) is not detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a ventilator, not an AI-assisted diagnostic tool for "human readers." The comparative testing performed was between the Vivo 45 LS and its predicate devices (Vivo 60 and Trilogy Evo) to demonstrate technological equivalence, not to evaluate human performance with or without AI assistance.

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

This refers to the performance of the device itself (the "algorithm only" being the device's operational logic and hardware). The document describes extensive standalone performance testing of the Vivo 45 LS against various standards and specifications. This includes:

• Waveform performance (flow, pressure, volume)
• Triggering performance
• Accuracy of controls and monitored values
• Performance of specific ventilation modes (MPV, SIMV)
• Alarm system operation
• Power management
• Cybersecurity
• RFID immunity
• Software verification and validation
• Biocompatibility

These tests evaluate the device's inherent function without human intervention during the measurement or operation for the test itself, thus representing its standalone technical performance.

7. The type of ground truth used

The ground truth for the various performance tests was primarily based on:

• International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 80601 series, ISO 18562 series. The criteria within these standards define what constitutes acceptable performance.
• Device Specifications: The manufacturer's own predefined accuracy specifications and operational parameters.
• Predicate Device Performance: For comparative testing, the performance of the legally marketed predicate devices (Vivo 60 and Trilogy Evo) served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes the premarket notification for a medical device (ventilator), not a machine learning or AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no mention of a training set or AI algorithm for which ground truth would be established.

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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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The Vivo 60 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.)

The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 60 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 60 is not intended to be used as a transport or critical care ventilator.

The Vivo 60 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read through flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 60 can be operated by external AC or DC power supply and contains an integrated battery as well as an additional click on battery.

The Vivo 60 can be used with three types of patient circuits: single limb patient circuits including an active exhalation valve, single limb patient circuits including a passive leakage port, and dual limb patient circuits.

This document describes the regulatory submission for the Vivo 60 ventilator and its substantial equivalence to predicate devices (Vivo 50 and Astral 110/150). It outlines various performance tests conducted to demonstrate compliance with specifications and recognized standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a single, consolidated table of acceptance criteria (i.e., specific numerical or qualitative thresholds that the device had to meet) alongside the reported device performance in the format you requested. Instead, it lists numerous recognized standards to which the device was tested and then broadly states that the device "conforms with all requirements specifications and applicable standards" and "meets its accuracy specifications."

Here's a partial summary of the performance testing mentioned, but without explicit acceptance criteria or detailed quantitative results:

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for any specific test set for the performance testing. For most tests, it mentions "the Vivo 60" or "comparative testing with the Vivo 50 and Astral predicate devices" without specifying the number of devices or number of tests performed.

Data provenance is not mentioned (e.g., country of origin, retrospective or prospective). The testing appears to be primarily lab-based engineering verification and validation testing rather than clinical study data from patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The testing described is largely engineering and technical conformance, which would typically rely on calibrated instruments and defined standards rather than expert medical interpretation for "ground truth" as it would be for an AI diagnostic device.

4. Adjudication Method

This information is not provided. Given the nature of the tests outlined (e.g., electrical safety, waveform comparison, accuracy of controls), expert adjudication as seen in clinical studies for diagnostic accuracy would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This device is a ventilator, not an AI-powered diagnostic system where human readers would be assessing cases with and without AI assistance. The performance testing focuses on the device's technical and safety specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study in the context of an AI algorithm was not explicitly described for diagnostic performance. However, the numerous performance tests listed (e.g., waveform performance, triggering, accuracy of controls, software V&V) can be considered "standalone" in the sense that they evaluate the device's inherent function against its specifications and standards, independent of direct human operational impact during the test. The ventilator's control algorithms were tested, but not as a "standalone AI" for diagnostic purposes.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Recognized Standards: e.g., IEC 60601-1, ISO 80601-2-72, EPA PM2.5.
• Manufacturer's Specifications: The device was tested to confirm it "meets its accuracy specifications" and "conform to specifications."
• Predicate Device Performance: Waveform comparisons were made to predicate devices (Vivo 50 and Astral).
• Expected Functionality: For triggering, the "ground truth" was detecting patient efforts without false triggers, as "intended."

8. Sample Size for the Training Set

This information is not applicable/provided. The Vivo 60 is a conventional mechanical ventilator, not an AI/machine learning device that requires a training set in the typical sense of AI algorithm development for diagnostic or predictive tasks. Its "algorithms" refer to control logic, not learned models.

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

This information is not applicable/provided for the same reason as #8. The control algorithms of the ventilator are based on engineering design and physiological principles, not on "ground truth" established from data used to train a machine learning model.

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VivoSight Dx is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.

VivoSight Dx is a Multi-Beam Optical Coherence Tomography (OCT) system.

This document is a 510(k) clearance letter for the VivoSight Dx Topical OCT System. It does not contain information about specific acceptance criteria, device performance results, or details of a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed Michelson Diagnostics Ltd.'s premarket notification and determined that the VivoSight Dx device is substantially equivalent to legally marketed predicate devices. This determination is based on the provided "Indications for Use" and generally implies that the device performs as intended and is safe and effective when used as described, similar to comparable devices already on the market.

Therefore, I cannot provide the requested information from this document. The information you're asking for would typically be found in the 510(k) submission itself, where the manufacturer presents data and analysis to support their claims of substantial equivalence. This letter is simply the FDA's decision based on that submission.

To answer your questions, I would need access to the actual 510(k) submission document for K153283, specifically the sections detailing performance testing and clinical data.

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Vivorté Trabexus™ EB" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté Trabexus™ EB™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ EB" may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus " EB" is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). The device is provided in kit sizes of 3 cc. 5 cc. and 10 cc. corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

This document describes a 510(k) premarket notification for the Vivorté Trabexus™ EB™ device. The submission primarily focuses on establishing substantial equivalence to a predicate device, the Vivorté BVF™. The core of the submission emphasizes that the only difference in the subject device is the inclusion of an additional accessory (a delivery cannula). As such, the presented information does not detail a study proving the device meets clinical acceptance criteria in the way one might expect for a novel therapeutic or diagnostic device. Instead, the "acceptance criteria" and "study" are primarily focused on non-clinical performance and equivalence to the predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Extrudability: The "Not applicable" result for extrudability is unusual for a bone void filler that is "applied to the defect through a cannula." This likely implies that the predicate device already demonstrated acceptable extrudability, and since the subject device is essentially the same formulation with just an added cannula, the company may have argued that the existing extrudability data on the formulation itself, or the new testing was not deemed necessary for the new device because it was simply an accessory. However, it is a significant omission if the new cannula itself was not tested for extrudability with the material.

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

The document does not specify sample sizes for the non-clinical tests (Biocompatibility, Bubble leak test, Heat seal strength). It also does not specify dates or countries of origin for these non-clinical tests, nor whether they were retrospective or prospective. This information would typically be detailed in a more comprehensive test report, not necessarily summarized in the 510(k) summary.

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

This question is not applicable to this submission. The "test set" described here relates to non-clinical engineering and material properties, not clinical diagnostic or therapeutic outcomes requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This question is not applicable to this submission. Adjudication methods are used in clinical studies, typically for establishing ground truth or resolving discrepancies in readings. The tests performed are objective laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

This question is not applicable to this submission. The Vivorté Trabexus™ EB™ is a medical device (bone void filler) and not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable to this submission. As stated above, this is a medical device, not an algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests, the "ground truth" is established by the predefined acceptance criteria for each test method (e.g., specific thresholds for biocompatibility, absence of bubbles, minimum seal strength). These are objective physical or chemical standards, not clinical outcomes or expert consensus.

8. Sample Size for the Training Set

This question is not applicable to this submission. There is no mention of a "training set" as this device does not involve machine learning or AI.

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

This question is not applicable to this submission. Since there is no training set, there is no ground truth establishment for it.

Summary of the Study and Acceptance Criteria (from the provided text's perspective):

The "study" described in the 510(k) Summary is primarily a non-clinical performance testing exercise aimed at demonstrating that the Vivorté Trabexus™ EB™ device, particularly with its new cannula accessory, maintains the safety and effectiveness characteristics of its predicate device, Vivorté BVF™.

The acceptance criteria are implied to be the successful completion ("Pass") of standard engineering and biocompatibility tests. The submission hinges on the argument that the subject device is "essentially the same as the predicate device" with only an added cannula accessory. The non-clinical testing was conducted "according to the design verification test methods indicated by the risk analysis." The successful passing of these tests forms the basis for demonstrating substantial equivalence and, by extension, that the device meets its core acceptance criteria for safety and performance in the context of this 510(k) submission. No clinical efficacy or safety studies were presented in this summary section, as substantial equivalence to a legally marketed predicate device often relies heavily on non-clinical data if the changes are minor.

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Vivorté Trabexus" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus" is resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. The device is provided in kit sizes of 3 cc, 5 cc, and 10 cc, corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

This document is a 510(k) premarket notification for the Vivorté Trabexus™ device. It doesn't contain a detailed clinical study with acceptance criteria and device performance results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device based on bench testing.

Therefore, many of the requested sections regarding acceptance criteria, study details, ground truth, experts, and human reader performance cannot be fully extracted from this document.

However, I can extract the available information regarding non-clinical testing and the comparison to the predicate device.

Key Findings from the Document:

The Vivorté Trabexus™ is a new version of an existing device (Vivorté BVF™ Lite™). The primary difference is the inclusion of an additional accessory: a delivery cannula. The substantial equivalence is based on the argument that this accessory does not impact the safety and effectiveness of the device.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide specific quantitative acceptance criteria or detailed device performance metrics beyond "Pass" for the non-clinical tests.

Note: The document states "Performance testing according to the design verification test methods indicated by the risk analysis was conducted." However, it does not detail these test methods or specific quantitative acceptance criteria. The "Not applicable" for Extrudability suggests that this test might have been relevant for the predicate device but perhaps less so for the new device given the cannula accessory.

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not explicitly stated, but these are likely in-house (Vivorté, Inc.) non-clinical bench tests. The country of origin for the data is not mentioned. The tests are retrospective in the sense that they were conducted for this 510(k) submission.

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

• Not applicable. This document describes non-clinical bench testing, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical bench testing, not a study requiring adjudication of expert interpretations.

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

• No. This was not a clinical study involving human readers or AI.

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

• No. This document does not describe an algorithm or AI.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" would be the established scientific and engineering principles and standards for evaluating the properties of medical devices (e.g., biocompatibility standards, packaging integrity standards).

8. The Sample Size for the Training Set

• Not applicable. This document does not describe an AI/ML algorithm or a training set.

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

• Not applicable. This document does not describe an AI/ML algorithm or a training set.

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