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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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Vivorté BVF™ 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 BVF™ 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 BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté BVF™ 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 BVF™ 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 BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.

The provided document describes a 510(k) premarket notification for a medical device called Vivorté BVF™. A 510(k) submission generally aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the concept of "acceptance criteria" as applied to a device's performance in a standalone clinical efficacy study might not directly align with the information typically found in a 510(k) summary.

Based on the provided text, the Vivorté BVF™ device is claiming substantial equivalence to two predicate devices: ETEX EquivaBone® Osteoinductive Bone Graft Substitute (K090855) and Synthes® Norian® SRS® Bone Void Filler (K011897). The "study" demonstrating this substantial equivalence is primarily focused on non-clinical testing.

Here's an analysis of the provided information in response to your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence, specific "acceptance criteria" for clinical performance are not explicitly detailed in the document in the way one might expect for a PMA or a de novo submission. Instead, the acceptance criteria are implicitly met by demonstrating comparable characteristics to the predicate devices through non-clinical testing.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for performance. The "test set" here refers to materials and animal models used for non-clinical and animal testing. Specific sample sizes for the chemical, physical, mechanical, biocompatibility, and animal testing are not provided in this summary.
• Data Provenance: The testing was performed by Vivorté, Inc. and its contractors. The country of origin for the data is implicitly the United States, where Vivorté, Inc. is located and operates. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

• Number of Experts: Not applicable. Ground truth, in the clinical sense, would be established by medical experts for patient outcomes or diagnoses. No such clinical "ground truth" establishment is mentioned as part of this 510(k) submission. For the non-clinical and animal testing, the "ground truth" is defined by established scientific and regulatory standards (e.g., ISO, ASTM, USP) and laboratory protocols.
• Qualifications of Experts: Not specified. Testers performing the non-clinical and animal studies would be qualified scientists, engineers, and veterinarians/animal technicians relevant to their fields, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to resolve discrepancies in expert judgments for ground truth establishment. Since no clinical trials are described, this is not relevant. The "adjudication" for non-clinical tests typically involves adherence to validated methods and review by internal quality control or regulatory bodies.

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

• MRMC Study Done: No. An MRMC comparative effectiveness study is used to assess the impact of a device (often AI-assisted) on human reader performance in diagnostic tasks. Vivorté BVF™ is a bone void filler, not a diagnostic imaging device, and its 510(k) submission explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ and the predicate devices." Therefore, no MRMC study was conducted or is relevant.
• Effect Size of Human Readers with/without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done: Not applicable. This question concerns the performance of an algorithm without human intervention, typically for AI/ML diagnostic devices. Vivorté BVF™ is a physical medical device, and the concept of "standalone performance" for an algorithm is not relevant. The performance of the physical device is established through the non-clinical (chemical, physical, mechanical, biocompatibility) and animal testing to show substantial equivalence.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is based on established scientific and regulatory standards and measurement techniques for material properties (chemical composition, physical properties, mechanical strength), biocompatibility, and animal responses (for osteoinductive potential of the DBM component). It is not pathology, expert consensus on patient outcomes, or human-specific clinical outcomes data, as clinical testing was not performed.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. A "training set" refers to data used to train an algorithm, typically in AI/ML applications. Vivorté BVF™ is not an AI/ML device. The non-clinical and animal testing involved samples of the device and biological models for evaluation, but these are not "training sets" in the AI/ML context.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ 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 BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ 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 BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite), which closely resembles the mineral phase of bone, provides an osteoconductive scaffold for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

The provided text describes a 510(k) submission for the Vivorté BVF™ Lite™ bone void filler, asserting its substantial equivalence to a predicate device, Synthes® Norian® SRS® Bone Void Filler. The basis for this determination is non-clinical testing, as explicitly stated that no clinical testing was performed or required. Therefore, the acceptance criteria and the study proving the device meets them are solely based on these non-clinical evaluations.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria as numerical thresholds but rather states that the device is "substantially equivalent" to the predicate device in various aspects. The reported performance is therefore framed in terms of similarity to the predicate.

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests (chemical, physical, mechanical, biocompatibility, animal testing). The nature of these tests often involves specific numbers of samples per test type (e.g., a certain number of specimens for mechanical strength tests, a certain number of animals for animal studies), but these numbers are not detailed in the summary.
• Data Provenance: The data provenance is internal to Vivorté, Inc. or its contracted laboratories that performed the non-clinical tests. The document does not specify the country of origin for the data, but since the submission is to the U.S. FDA, it is presumed to be conducted under U.S. or internationally recognized standards for and applicable to the U.S. market. All testing described is non-clinical.

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

This question is not applicable as the submission relies solely on non-clinical testing for substantial equivalence, not on human expert evaluation of clinical data or images. Ground truth, in this context, would be established by validated laboratory assays, animal observations, and engineering measurements, not by expert consensus on patient data.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There was no clinical test set requiring human adjudication.

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 explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ Lite™ and the predicate device" and "No clinical tests were conducted or submitted in support of substantial equivalency." Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance to report, as there was no clinical study involving human readers or AI.

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

This question is not applicable. Vivorté BVF™ Lite™ is a physical medical device (bone void filler), not an algorithm or AI software, so standalone performance in the context of AI is irrelevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be derived from:

• Reference Standards/Validated Methods: For chemical composition, physical properties (e.g., density, porosity), and mechanical properties (e.g., compressive strength, bending strength), performance is measured against established scientific and engineering reference standards and/or the known properties of the predicate device.
• Biocompatibility Benchmarks: For biocompatibility and toxicity, the ground truth is established by adherence to recognized international standards (ISO 10993) and national standards (ASTM, USP).
• Animal Study Observations: For animal testing, the ground truth would be based on histological examination, imaging, and gross observations of bone formation, resorption, and overall tissue response in a controlled biological environment, compared to either (or both) untreated controls or the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense. The "knowledge base" for developing the device would stem from scientific literature, material science research, and established medical device development practices.

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

This question is not applicable for the same reasons as #8.

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The Vivo 50 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 at least 10 kg (22 lbs.).

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 50 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 50 is not intended to be used as a transport and critical care ventilator.

The Vivo 50 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.

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

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

The Vivo 50 can be operated by external AC or DC power supply and contains an integroted battery as well as an additional click on battery.

The Vivo 50 can be used with both single limb patient circuits including an active exhalation valve and single limb patient circuits including a leakage port.

The Vivo 50 can be operated in 9 different ventilation 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+TaV) Assisted Pressure Controlled Ventilation with Taraet Volume ●
• VCV Volume Controlled Ventilation
• VCV(A) Assisted Volume Controlled Ventilation ●
• CPAP Continuous Positive Airwav Pressure ●

The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software. The Vivo 50 PC Software is the support software for follow-up on patient treatment. The PC Software can communicate with the ventilator in two ways, either using an USB cable or a Compact Flash memory card.

The Vivo 50 PC Software provides presentation features of logged data by 24 hours, 30 days and 365 days resolution. The Vivo 50 PC Software presents treatment parameters such as pressure, volume, flow, leakage but also events such as alarms and change of settings. Further, the hours of usage is presented.

The Vivo 50 with the iOxy kit , consisting of an SpO2 (blood oxygen saturation) Nonin sensor, an electronic unit and cable, is intended to be connected to ventilator for logging SpO2 and pulse rate data and, when applicable, for real time monitoring. The SpO2 and pulse rate measurements are stored in the Vivo 50 internal memory log which can be downloaded to a PC and viewed in the Vivo 50 PC software. The SpO2 sensors are manufactured by Nonin Medical Inc.

The Vivo 50 with the CO2 sensor can be connected with the purpose to measure and display End Tidal CO2 (EtCO2) as well as Inspired CO2 (InspCO2). The EtCO2 displays the end-tidal carbon dioxide, measured on the last portion of the exhaled volume. The InspCO2 displays the inspired carbon dioxide.

The CO2 sensor can be connected to the patient breathing circuit and to the Vivo 50 in order to monitor and store CO2 measurements. The CO2 measurements will be stored in the Vivo 50 data memory which can be downloaded to a PC and viewed in the Vivo 50 PC software.

The CO2 sensor used with the Vivo 50 is manufactured by PHASEIN AB and is in used with PHASIEN AB carbon dioxide gas analyser cleared device under K081601 & K123043.

The Vivo 50 Remote Alarm Unit enables care providers and clinical personnel to monitor the Vivo 50 alarms remotely. The Remote Alarm unit is connected to the ventilator via a 10. 25 or 50 meter cable and powered by the ventilator. The Remote Alarm repeats alarms from the Vivo 50. The alarm signal sound level may be adjusted by the user. The actions or adjustments on the Remote Alarm unit do not, in any way, affect the alarm indications, alarm sound level, or audio pause on the Vivo 50.

This device is a ventilator, and the provided document is a 510(k) summary for its clearance. For ventilators, acceptance criteria and associated "studies" typically refer to compliance with recognized standards and internal verification/validation testing rather than clinical performance studies measuring accuracy metrics like sensitivity/specificity against ground truth. The document explicitly states that no clinical studies were required or performed to support substantial equivalence for the Vivo 50.

Therefore, the "acceptance criteria" for this device are its compliance with various medical device standards and the internal non-clinical testing performed by the manufacturer.

Here's the information extracted and formatted as requested, with explanations where direct answers are not applicable due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission explicitly states "The subject of this premarket submission, Vivo 50 did not require clinical studies to support substantial equivalence." The testing described is non-clinical (verification and validation against specifications and standards), not a clinical 'test set' with patient data.
• Data Provenance: Not applicable, as there was no clinical test set using patient data. All testing mentioned is internal, non-clinical lab/bench testing.

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

• Not applicable. There was no clinical test set requiring ground truth established by experts.

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

• Not applicable. There was no clinical test set requiring adjudication.

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. No MRMC study was mentioned or performed. This device is a standalone ventilator, not an AI-assisted diagnostic tool that would involve human readers.

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

• The performance testing and standards compliance outlined in "Summary of Non-Clinical Tests" represent the standalone performance of the device against its specifications and relevant standards. This is not a specific "algorithm-only" study in the sense of a diagnostic AI, but rather the integrated system's performance. The device's functionality (e.g., controlling ventilation modes, displaying parameters, managing alarms) is intrinsically "standalone" in its operation.

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

• Not applicable. For non-clinical verification and validation of a medical device like a ventilator, the "ground truth" equates to the established engineering specifications for the device, and the requirements outlined in the applicable medical device standards (e.g., IEC 60601 series, ISO 9919, ISO 21647, ASTM F1246-91, ASTM F1100). Performance is measured against these objective, predefined criteria.

8. The sample size for the training set:

• Not applicable. This document describes a medical device (ventilator) that underwent traditional engineering verification and validation, not a machine learning or AI algorithm development process that typically involves a "training set."

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

• Not applicable. As there was no training set (see point 8), no ground truth was established for it.

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VivoSight 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.

Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system

The provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "VivoSight Topical OCT System".

It primarily discusses:

• Device Identification: Trade Name, Common Name, Classification, Predicate Device.
• Intended Use: "Intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization."
• FDA Clearance: Confirmation of substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested table and study details based on the input.

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Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.

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I am sorry, but the provided text is a 510(k) summary from the FDA for the Vivosonic NeuroScreen™ Infant Hearing Screener. It outlines the regulatory approval process and includes the indications for use.

However, it does not contain any information about the acceptance criteria, the specific study conducted to prove device performance, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request for this information based on the provided text.

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The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists. The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.

This document is a 510(k) summary for the VivoSorb Sheet, a medical device. It does not describe an AI/ML powered device, therefore the standard acceptance criteria for such a device are not applicable.

Here's an analysis of the provided information, focusing on the device's performance claims and the study used to support them, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative manner as would be expected for an AI system, nor does it present specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

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

• Sample Size for Test Set: The document does not specify the sample sizes used for the "design verification tests" or "animal tests." It only lists the types of tests performed (e.g., in vitro suture retention, degradation, aging, mechanical, biocompatibility, animal tests).
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "design verification tests and analyses" and "animal tests."

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

This information is not applicable to this document as it describes a physical medical device and its performance, not an AI/ML system that requires ground truth established by experts. The "ground truth" here would be the physical properties and biological responses observed in the tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No expert adjudication method is described or required for the device's physical and biological testing.

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

This information is not applicable. The device is a physical surgical mesh, not an AI system intended to assist human readers. Therefore, an MRMC study is not relevant.

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

This information is not applicable. The device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" was established through:

• Objective Measurement/Pathology: This would include direct measurements from the "in vitro suture retention testing," "in vitro degradation testing," "aging testing," and "mechanical testing." For "biocompatibility testing" and "animal tests," "pathology" (histological analysis, observation of biological responses) would be used to assess safety and interaction with biological tissues.
• Literature and Predicate Device Comparison: The determination of "substantial equivalence" also relies on the established performance and safety profiles of the predicate devices and existing scientific literature.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

This information is not applicable. As it's not an AI/ML model, there is no "training set" and associated ground truth in that context. The "ground truth" for the device's development would be based on engineering principles, material science, and biological understanding, informed by pre-clinical testing mentioned in point 7.

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The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.

The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.

The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.

The Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.

Vivo 200 DPS™ Version 2.0 is a diagnostic system that assists clinical professionals in the assessment and screening of cochlear function. The device includes a probe with a disposable tip that fits in the patient's ear canal. The probe contains a tiny speaker for stimulating the patient's ear with sound and a microphone for receiving low-volume otoacoustic emissions (OAEs).

The probe is connected to a probe adaptor circuit that generates the acoustic stimuli and amplifies the OAE responses. The probe adaptor circuit initiates stimulus delivery under the control of a dedicated notebook computer. The notebook computer reads the response from the probe adaptor and processes the signal digitally to measure and detect the OAE signal level, estimate the noise and display the results.

The Vivo 200 DPS™ Version 2.0 probe adaptor is capable of producing stimuli and eliciting Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). TEOAEs are produced by the cochlea in response to short duration click sounds. DPOAEs are produced in response to two continuous pure tones that are close to each other in frequency.

The Vivo 200 DPS™ Version 2.0 software contains digital signal processing algorithms for measuring and detecting responses to both types of OAEs. The DPOAE and TEOAE responses are acquired and detected using the same probe. probe adaptor circuit and computer interface. The stimuli for both types of OAEs use the same probe, amplification circuitry and computer interface but utilize different modules in the probe adaptor circuit to generate their respective waveforms.

Software running on the notebook computer under the Windows XP™ operating system incorporates a graphical user interface that allows the user to configure the OAE test protocol, initiate and stop the test, print, save and review test results, and store patient information.

The provided document, K033108, is a 510(k) Summary for the Vivo 200 DPS VivoScan™ Version 2.0 OAE Audiometer. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics.

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

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

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific response levels) for the Vivo 200 DPS VivoScan™ Version 2.0. The primary "performance" discussed is its substantial equivalence to a predicate device.

The main change in this version is the addition of Transient Evoked Otoacoustic Emissions (TEOAE) functionality. The "Software algorithm" comparison parameter notes:

This indicates the method used for TEOAE processing, but not its performance against a specific criterion. The document also states that the device "is designed to meet the EN 60601 series of standards for electromagnetic (EMI) and electrical safety," which are safety and electrical performance standards, not diagnostic performance acceptance criteria.

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

The document does not provide details about a specific test set, its sample size, data provenance, or study type (retrospective/prospective) for evaluating the diagnostic performance of the Vivo 200 DPS VivoScan™ Version 2.0. The submission is a 510(k) for substantial equivalence, which often relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate device, sometimes without new clinical studies if the changes are minor.

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)

Since no specific test set or study validating diagnostic performance is detailed, there is no information provided on the number or qualifications of experts used to establish ground truth.

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

Given the lack of a detailed performance study with a test set, no adjudication method is mentioned.

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

The document does not mention any MRMC comparative effectiveness study or any AI component that would assist human readers. The device is described as a diagnostic system that assists clinical professionals by measuring, recording, and displaying otoacoustic emissions, implying it's a measurement tool rather than an AI-assisted diagnostic aid in the modern sense.

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

While the device includes "digital signal processing algorithms" for measuring and detecting responses, the document does not describe a standalone performance study of these algorithms in isolation (i.e., algorithm only without human-in-the-loop performance as a diagnostic tool). The device is intended for use by a "trained health care professional."

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

Since no specific performance study with a test set is described, the type of ground truth used is not mentioned.

8. The sample size for the training set

The document does not describe a training set sample size. This type of information is typically related to machine learning models, which are not explicitly detailed as a primary component of this device beyond "digital signal processing algorithms."

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

As no training set is described, how ground truth for a training set was established is not provided.

Summary of what is present in the document:

The 510(k) summary primarily asserts substantial equivalence to a predicate device, noting the addition of TEOAE functionality using digital signal processing algorithms (averaging and FFT). It defines the device's intended use and patient population. It does not provide details of clinical studies, performance metrics, acceptance criteria, or ground truth establishment typically found in submissions with novel diagnostic algorithms requiring such validation. The focus is on demonstrating that the updated device is safe and effective in a manner similar to its predecessor.

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VivoSonic™ will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between patient and medical imaging electronics and to lubricate the insertion and passage of imaging devices, such as ultrasound transducers and endoscopes.

VivoSonic™ is intended for use in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and opthalmic ultrasound imaging.

VivoSonic™ is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures which currently use and ultrasound coupling gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and/or in vivo biocompatibility are required.

VivoSonic™ is an in vivo biocompatible sterile ultrasound couplant and lubricant that couples or conducts ultrasound between the body and the ultrasound transducer and electronics.

The VivoSonic™ formulation is in vivo biocompatible with tissue and body fluids and is recognized as safe for oral administration (1)

This is a 510(k) Premarket Notification for the VivoSonic™ Diagnostic Ultrasound Imaging Coupling Media. This document does not contain information about the performance of an AI/ML device.

The provided text describes a medical device (ultrasound coupling media) and its intended use, and states that it is substantially equivalent to other legally marketed predicate devices. It covers regulatory information, device classification, and indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, study details, ground truth establishment, or human-in-the-loop performance, as these topics are not present in the provided submission for this type of device.

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