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Xper Flex Cardio Physiomonitoring System-The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing. and analytical assessment. The system is indicated for use in the cardiac catheterization, following areas: cardiology, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

Xper Information Management- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data. such as physiologic/ hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multichannel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

The system is indicated for use in the following areas: cardiology, cardiac catheterization. electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed.

The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system.

The system is capable of receiving and displaying user-adjustable alarms (both visual and audible) available in the system, which alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

The Xper Flex Cardio physiomonitoring system and Xper Information Management systems are enhancements of the cleared Xper Information Management system (K063840).

The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, SpO2 (pulse oximetry), end tidal CO2 (ETCO2) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status. The Xper Flex Cardio physiomonitoring system is not intended for use in the proximity of magnetic resonance imaging.

The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices.

The provided 510(k) summary for the "Xper Flex Cardio Physiomonitoring System" and "Xper Information Management System" does not describe acceptance criteria for specific performance metrics or a study that rigorously proves the device meets those criteria in terms of clinical accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Technological Characteristics: Highlighting similarities in intended use, components, and functionalities with existing cleared devices.
• Performance Testing (Compliance to Standards): Showing the device complies with relevant international electrotechnical commission (IEC) safety and electromagnetic compatibility (EMC) standards. This is a common method for medical devices to show basic safety and performance in their specific operating environment.

Here's an breakdown based on your requested information, with the understanding that the provided document does not contain the level of detail you might expect for an AI-centric device's performance study:

1. Table of Acceptance Criteria and Reported Device Performance

• "The results of the safety and performance testing demonstrate that the Xper Flex Cardio physiomonitoring system and the Xper Information Management System are as safe and effective as the predicate device(s) and perform as well as the predicate device(s)."
  - Compliance with voluntary standards (IEC 60601 series). |
  | Safety & EMC | Compliance with the following voluntary standards:
• IEC 60601-1 (General Requirements for Safety)
• IEC 60601-1-1
• EN 60601-1-2
• IEC 60601-2-30
• IEC 60601-2-49 |
  | System Functionality | The device is capable of:
  - Displaying and analyzing surface ECG, respiration, invasive pressure, SpO2, ETCO2, NIBP, surface body temperature, thermal cardiac output curves.
• Processing/analyzing multi-channel ECG signals, displaying graphical ST segment maps.
• Acquiring, displaying, trending, storing, and transmitting various types of data (physiologic/hemodynamic, clinical, medical image).
• Creating reports.
• Receiving and displaying user-adjustable visual and audible alarms.
• Transmitting patient data files for storage, viewing, and analysis. |
  | Substantial Equivalence | Demonstrated by comparing the device's technological characteristics, intended use, and performance testing results to several predicate devices (Xper Information Management System K063840, GE MacLab/CardioLab EP/ComboLab System K050093, Poise DataEngine K040969, Siemens AXIOM Sensis K020440, Alliance Instruments Integrity Patient Monitor K980688). |

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

• Sample Size: Not specified. The document refers to "Performance Testing" and "hazard analysis" which implies testing was conducted, but details on sample size (e.g., number of patients, number of data points) are absent.
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable. The submission does not describe a study involving expert review for ground truth establishment.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance evaluation.

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

• Was an MRMC study done? No. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance.
• Effect Size: Not applicable.

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

• Was a standalone study done? The document refers to the introduction of a "Philips ECG algorithm (individually cleared in K073376)". While this indicates an algorithm is part of the system, the provided 510(k) for the current device does not detail a standalone performance study for this specific algorithm or any other algorithms within the system in this submission. Its prior clearance implies a study was done for that specific component at that time.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated as expert consensus, pathology, or outcomes data for the overall system. The performance testing is primarily focused on compliance with safety and electrical standards and demonstrating functionality, rather than establishing a clinical ground truth for diagnostic accuracy in a patient cohort.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The document does not describe a training set in the context of machine learning or AI model development for the device as a whole. While an ECG algorithm is mentioned, its training details are not part of this submission.

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

• How Ground Truth was Established: Not applicable. As no training set is described for the device in this submission, the method for establishing its ground truth is not mentioned.

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Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.

Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The Xper Information Management device is intended to be used for complete physiologic/hemodynamic monitoring and information gathering as well as medical image review through links to cleared devices. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

The provided text focuses on the 510(k) summary for the Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station, and ECG Management system. It describes the device, its intended use, and states its substantial equivalence to a predicate device based on "Performance Testing as well as the Hazard analysis." However, it does not provide specific acceptance criteria, detailed results from performance tests, or information about specific studies that demonstrate the device meets acceptance criteria.

The document states that the modifications to the device primarily involve:

• Introduction of a new trade name.
• GUI updates.
• Upgrades in hardware and software to facilitate integration of the latest technology.

It explicitly mentions that the modified device has the "same technological characteristics as the legally marketed predicate device (K033030)." This strongly suggests that the focus of the 510(k) submission was on demonstrating that these changes did not adversely affect the device's fundamental safety and effectiveness, rather than performing entirely new clinical or detailed performance studies against novel acceptance criteria.

Therefore, for most of the requested information, the answer will be that the details are not available in the provided text.

Here's an attempt to answer the questions based on the available information:

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

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

Not provided in the document. The text refers to "Performance Testing" and "Hazard analysis" but does not detail the nature of these tests, the data sources, or sample sizes.

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 provided in the document. This type of information would typically be detailed in a more comprehensive clinical study report, which is not part of this 510(k) summary. Given the nature of the device (physiomonitoring and information management, not diagnostic interpretation), "ground truth" in the diagnostic sense might not be applicable in the same way as for an AI-powered diagnostic tool. The document states "Its users, responsible to interpret the data made available, will be professional health care providers."

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

Not provided in the document.

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 done. This device is described as a physiomonitoring and information management system, not an AI-assisted diagnostic tool that aids human readers in interpretation. The document explicitly states for the ECG Management System that it "does not provide interpretive functions."

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

Not applicable in the context of this device as described. The device "facilitates clinical data acquisition and analytical assessment" and its "users, responsible to interpret the data made available, will be professional health care providers." The ECG Management System "does not provide interpretive functions."

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

Not explicitly stated. Given that the device handles "physiologic/hemodynamic monitoring" and "clinical data acquisition," the "ground truth" for its performance would likely relate to the accuracy of physiological measurements, data integrity, system functionality, and adherence to safety standards. However, the document does not specify how this "ground truth" was established for testing purposes.

8. The sample size for the training set

Not applicable/Not provided. This device is not described as an AI/ML device that requires a training set in the conventional sense for learning patterns or making predictions. It's a system for managing and displaying physiological data.

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

Not applicable/Not provided. As above, this is not an AI/ML device requiring a training set with established ground truth for learning.

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The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.

Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

The provided text describes modifications to the CALYSTO Series IV Physio-monitoring and Information System. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a comprehensive study report in the way a PMA submission might.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a de novo device or a device with new functionality is not explicitly detailed in this document. The focus here is on showing that the modifications do not alter the fundamental safety and effectiveness of the device compared to its predicate.

Here's an analysis based on the provided text:

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

The document summarizes the testing as: "Verification, validation and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Pass/Fail criteria were based on the specifications cleared for the predicate device and the test results showed substantial equivalence."

This indicates that the acceptance criteria were the specifications of the predicate device, and the reported device performance was that it met these specifications, demonstrating substantial equivalence. Specific quantitative criteria and results for parameters like accuracy, precision, sensitivity, or specificity for the new modules are not provided in this summary.

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

• Sample Size: Not specified. The document states "Verification, validation and testing activities," but does not detail the nature or scope of these activities in terms of sample size for clinical or simulated data.
• Data Provenance: Not specified. Given the nature of medical device testing for 510(k) modifications, the testing would typically involve laboratory and/or simulated clinical environments. It's highly unlikely to involve patient data provenance in the way a diagnostic AI product might.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not specified. This submission is for modifications to a physiological monitor, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. The validation would primarily focus on technical specifications and accuracy against established calibration standards or reference devices, not human expert consensus.

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

Not applicable/Not specified. Adjudication methods are typically used when human interpretation or diagnosis is part of establishing ground truth for diagnostic devices. This document describes a physiological monitoring system.

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. This device is a physiological monitor and central station system. It does not appear to incorporate AI for diagnostic assistance that would warrant an MRMC study comparing human reader performance.

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

The device itself is a standalone physiological monitor. The testing would have evaluated the performance of the integrated modules (End Tidal CO2 and pulse oximetry) in a standalone manner against their specifications. The document states, "The specifications and accuracy of the proposed modules are equivalent to the currently legally marketed predicate device." This implies standalone testing of component performance.

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

The ground truth for this type of device (physiological monitor) would be established by:

• Reference standards: Calibrated test equipment, simulated physiological signals, or comparison against established "gold standard" medical devices.
• Manufacturer specifications: The performance specifications provided by the manufacturers of the integrated modules (Respironics and Masimo), which would have been validated during their own development.

8. The sample size for the training set:

Not applicable. This device does not appear to use machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm. The modifications involve integrating established physiological monitoring modules.

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

Not applicable, as there is no apparent training set for an AI algorithm.

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CALYSTO Image IV is an image and information management system intended for image data acquisition, archival, distribution, viewing and analysis for medical images of all modalities as well as Electrocardiogram (ECG) images. It's users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Image IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format. and made available for review and procedural report generation purposes. CALYSTO ECG Management System does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users. responsible to interpret the data made available, will be professional health care providers. CALYSTO ECG Management System provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet, or may function as a stand-alone device.

CALYSTO Image IV is an image and information management system. The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets said criteria for the "CALYSTO Image IV - Image and Information Management System."

The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the device's indications for use and regulatory classification, but it does not detail any performance studies, acceptance criteria, or specific metrics about the device's performance. Therefore, I cannot generate the requested table and study information.

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The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.

The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter from the FDA for the Witt Biomedical Corporation's Calysto Series IV, Patient Care Monitors and Central Station, and ECG Management System. It primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to predicate devices.
• Regulatory Classification: The device is classified as Class II, under Regulation Number 21 CFR 870.2300 (Cardiac Monitor).
• General Controls and Additional Regulations: Information about applicable FDA regulations.
• Indications for Use: Detailed descriptions of how the device is intended to be used.

To answer your request, information regarding a specific study, acceptance criteria (e.g., sensitivity, specificity, accuracy targets), and the methodology used to demonstrate performance would need to be present. This type of information is typically found in the 510(k) submission itself (which includes performance data and clinical studies if applicable), but not usually in the FDA's clearance letter.

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The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide continuous monitoring of patient physiological parameters, generate alarms (both visual and audible), alerting operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory intensive care, coronary care, post anesthesia recovery, operating room, medical intensive care, pediatrics intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough display of monitoring parameters which use proven algorithms and are displayed in a logical, easily understood format that requires only familiarity to the users of any Witt Biomedical system.

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.

Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.

I am sorry, but the provided text does not contain the necessary information to answer your request regarding the acceptance criteria and study details for the Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It includes the device name, indications for use, and regulatory classification but does not detail the specific performance acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical study report or performance evaluation.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or training set details based on this document.

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