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The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The No Color 8MP (MDNC-8132) is a medical computer display designed for general radiology applications. The device can also be used for home reading in radiology. The display is a high-resolution LCD monitor with characteristics that are important for accurate medical image review: high luminance, good luminance uniformity, good luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightness over the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis. The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView and AAM – Application Appearance Manager. The display can be used with or without the Barco MXRT display controller boards.

The provided document is a 510(k) summary for the Barco Nio Color 8MP (MDNC-8132) medical display. It details the device, its intended use, and a comparison to a predicate device (Nio Color 2MP, MDNC-2521) to demonstrate substantial equivalence.

Based on the information provided, here's an analysis of the acceptance criteria and the study proving the device meets them:

Crucially, this document does not describe a study involving AI or human reader performance. It describes a comparison of a medical display device to a predicate device based on technical specifications and bench testing. Therefore, many of the requested points related to AI, human readers, ground truth establishment, and training sets are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be based on demonstrating "similar characteristics" and "equivalence" to the predicate device MDNC-2521 across various physical and performance metrics for a medical display. The general acceptance is that the modifications "did not reveal new issues of safety and performance" compared to the cleared predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a medical display submission, not AI)

Given that this is a submission for a medical display device demonstrating substantial equivalence to a predicate, and not an AI/software as a medical device (SaMD), the following points are largely not applicable or interpreted within the context of hardware testing.

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

   • The test set consists of the Barco Nio Color 8MP (MDNC-8132) device itself. The "sample size" is essentially n=1 (one type of device being tested). There isn't a "data set" in the traditional sense of medical images or patient data.
   • Data provenance: Not applicable in the sense of patient data. The tests were performed on the physical device as per "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022.

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

   • Not applicable. There is no "ground truth" to be established by experts in the context of diagnostic performance on images, as this is a display device. The "truth" here is whether the display's physical and photometric characteristics meet predetermined engineering and regulatory standards (e.g., DICOM GSDF conformance) and are equivalent to the predicate. This is typically verified by specialized testing equipment and procedures.

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

   • Not applicable. Adjudication is relevant for expert agreement on medical findings, not for objective physical measurements of a display.

4. 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, this was not done. This is a submission for a medical display, not an AI device. The document explicitly states: "No animal testing or clinical testing has been performed."

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

   • No, this was not done. This is a display device, not an algorithm.

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

   • Not applicable in the medical context. The "ground truth" for this device's performance are the established technical specifications and performance characteristics outlined in industry standards (like DICOM) and the FDA guidance for display devices. The comparison is made against the performance of a legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not use a "training set" as it is a hardware display, not an AI algorithm.

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

   • Not applicable. (See point 7).

Summary of the Study:

The study proving the device meets the acceptance criteria is a series of bench tests conducted on the Nio Color 8MP (MDNC-8132) display. These tests were performed according to the "Physical Laboratory Testing instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology'" (2022). The purpose was to demonstrate that the MDNC-8132 possesses "similar characteristics" and is "equivalent" in performance to the predicate device, the Nio Color 2MP (MDNC-2521), across various critical display parameters such as spatial resolution, luminance, uniformity, reflection, and color tracking. The document concludes that these tests "did not reveal new issues of safety and performance" and confirmed its substantial equivalence to the predicate. Additionally, compliance with EMC and Safety standards, and passing environmental tests, contributed to the conclusion of substantial equivalence. No clinical or animal testing was performed, as the
demonstration of equivalence was based solely on technical and performance bench testing.

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The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.

The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,

The Barco Nexxis OR system allows control and selection of these signals from a central point.

The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,

The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

The Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The Nexxis OR can consist of any possible combination of the Nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the Nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The Nexxis OR system can also contain, optionally, the MNC-180 compositor device, a MDSC-8258 MNA display and/or the touch user interface MUIP-2112. The Nexxis OR system may now consist of any combination of the following components: a) Nexxis OR components (Medical network adaptors) b) Nexxis Compositor with NCS composition software (MNC-180) c) Nexxis Management Suite (NMS). d) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.(optional) e) touch user interface MUIP-2112 (optional) f) Cables g) Documentation

The provided document is a 510(k) premarket notification for the Barco Nexxis OR system, which is a video distribution solution for operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.

Therefore, many of the requested elements for a diagnostic device's acceptance criteria and study cannot be extracted from this document.

Here's what can be gathered and what cannot:

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

The document does not provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "acceptance criteria" can be inferred as demonstration of similar characteristics in terms of safety and effectiveness compared to the predicate device.

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

This information is not provided in the document. The testing described ("Display bench tests," "Display validation tests," "Nexxis OR qualification tests," "System tests") appears to be engineering and system validation rather than clinical performance testing with a "test set" of medical images or patient data.

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)

This information is not applicable/not provided. The device is a video distribution system, not a diagnostic algorithm that relies on expert interpretation of output.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. This is not a diagnostic device with an AI component for image interpretation.

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

This information is not applicable/not provided. This is a system for distributing video signals, not a standalone diagnostic algorithm.

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

This information is not applicable/not provided. Ground truth in a clinical sense would not be relevant for the device itself, though the medical images it transmits would have their own ground truth established outside the scope of this device.

8. The sample size for the training set

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

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

This information is not applicable/not provided.

Summary based on information provided in the document:

The Barco Nexxis OR system is a medical video distribution system. The study to demonstrate its performance and meet acceptance criteria primarily consisted of bench tests and system qualification tests. These tests aimed to show that the device has similar characteristics to its predicate device (Nexxis OR cleared under K170537) and did not reveal new issues of safety and effectiveness. The document explicitly states that "Animal or clinical testing have not been performed," indicating that the "study" was not a clinical trial in the traditional sense, but rather engineering and functional validation.

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The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated display system designed to review and interpret digital images of surgical pathology slides.

The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be calibrated to the sRGB gamut.

Accessories:

• QAWeb quality assurance software
• DisplayPort cable
• USB cable
• AC power cord cables

The provided text describes a 510(k) submission for a medical device, the Barco MMPC-4127F1 (PP27QHD) display, which is intended for in vitro diagnostic use to display digital images of histopathology slides. The submission aims to demonstrate substantial equivalence to a predicate device.

The study presented is not for an AI/algorithm-only device, but for a display system. Therefore, many of the requested fields related to AI/algorithm performance (e.g., effect size, standalone performance, training set details, adjudication methods, multi-reader multi-case studies) are not applicable to this type of device. The acceptance criteria and performance testing focus on the display's technical characteristics and visual performance as they compare to the predicate device.

Here's an analysis based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for each parameter, but rather compares the new device's specifications directly to the predicate device's specifications. The implicit acceptance criterion is that the new device's performance should be similar to or better than the predicate device without introducing new issues of safety or performance. The "reported device performance" is essentially the listed "New Device MMPC-4127F1 (PP27QHD)" specifications.

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The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

The generic Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The generic nexxis OR can consist of any possible combination of the nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The generic Nexxis OR system can also contain, optionally, the MNC-180 compositor device and/or a MDSC-8258 MNA display. The Nexxis OR system may consist of any combination of the following components: a) Nexxis OR components (MNA adapters (encoders and decoders), NMS management SW, network switches, SFP+ modules) b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional) c) Nexxis Compositor (MNC-180) (optional) d) Cables e) Documentation

The provided document describes the FDA 510(k) premarket notification for the Barco Nexxis OR system, a device for A/V signal and medical image distribution in operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions.

Based on the provided text, here's an analysis regarding acceptance criteria and the study that proves the device meets them:

Core Finding: This document does not describe a study that establishes detection or diagnostic performance metrics against a clinical ground truth for the Nexxis OR system. Instead, it describes bench testing to demonstrate the device meets specified performance characteristics compared to a predicate device. The acceptance criteria and "studies" are focused on engineering and functional equivalence rather than clinical diagnostic accuracy, as this is a video distribution system, not a diagnostic imaging device.

Acceptance Criteria and Reported Device Performance

The document states:
"The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and effectiveness."

While specific quantitative acceptance criteria are not explicitly detailed in a table, the document lists the types of tests performed:

The overall acceptance criterion is that the Nexxis OR system performs comparably or better than the predicate device without introducing new safety or effectiveness concerns, specifically for its function of distributing A/V signals and medical images.

Study Details (as inferable from the document)

Given that this is a video distribution system rather than a diagnostic AI or imaging device, the typical clinical study parameters requested (e.g., sample size for test set with ground truth, expert readers, MRMC, standalone performance) are not applicable in the context of this 510(k) submission. The "study" here refers to engineering and system performance testing.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" would be the configurations and operational scenarios of the Nexxis OR system itself. The document does not specify the number of test cases or images used; it refers to "bench tests," "display validation tests," "Nexxis OR qualification tests," and "system tests."
   • Data Provenance: Not applicable. The device handles existing clinical image data, but it does not generate or interpret new diagnostic data. The focus is on the faithful transmission and display of signals.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. Ground truth in this context would relate to the technical specifications and fidelity of A/V signal transmission, not clinical diagnoses. These tests would have been performed by engineers or qualified technical personnel, verifying signal integrity, latency, resolution, etc., against predefined technical standards.

3. Adjudication Method for the Test Set:

   • Not applicable. There is no "adjudication" in the clinical sense mentioned, as no human readers are interpreting diagnostic outcomes. Technical test results would be compared against engineering specifications.

4. 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, not done. This type of study is for diagnostic or AI-assisted devices that impact human reader performance. The Nexxis OR system is a signal distribution system, not an AI or diagnostic aid.

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

   • Not applicable. The device itself is a "standalone" system in its function (i.e., it performs its function of signal distribution independently). The concept of "standalone performance" for an algorithm's diagnostic accuracy is not relevant here. The bench and system tests would assess its technical performance.

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

   • The "ground truth" would be engineering specifications and technical standards for A/V signal quality, latency, resolution, and system functionality. For example, testing might involve comparing displayed image quality to source image quality, measuring signal latency, or verifying the correct routing of signals according to control inputs. This is not a clinical ground truth for diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. The Nexxis OR system is a hardware and software system for signal distribution, not a machine learning model that requires a training set.

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

   • Not applicable. No machine learning training set is involved.

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The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

The NIVR58-T kit is a set of devices bundled together by Barco as a system, to be used in a larger system of a customer.

The system that Barco composes, consists of the following devices:
a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.
b) Nexxis Compositor (MNC-180)
c) Nexxis OR components
d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.
e) Cables
f) Documentation

The NIVR58-T kit is the visualization part in an operating room or cathlab. The video sources from different medical devices in the OR are connected to the NIVR58-T kit. The NIVR58-T kit makes a composition of the video signals and sends the composition signals to the 58-inch display.

The selection of the video sources that have to be displayed and the layout of the composition is done by the Nexxis OR component and controlled by the control unit MTTP 0212, on which a Graphical User Interface is installed.

The provided text is a 510(k) premarket notification for the Barco NIVR58-T Kit, a medical device intended to integrate video from various instruments into a single display for healthcare professionals, primarily in operating rooms or cath labs.

Based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Core Finding: The document does NOT contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic performance.

Instead, this 510(k) focuses on demonstrating substantial equivalence to a previously cleared predicate device (SIVR56-T, K133994). The "studies" mentioned are bench tests to confirm that the new device has similar or superior characteristics without introducing new safety or effectiveness issues.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission, as it's not a diagnostic AI/ML device requiring clinical performance validation in the way implied by the question.

However, I can extract and present the relevant information that is present, addressing the spirit of the question within the context of a substantial equivalence claim for a display and video integration system.

Overview from the Document:

The NIVR58-T kit is a video integration and display system for medical use, specifically designed to combine video streams from various medical instruments onto a single large-screen display in an operating room or cath lab. The regulatory pathway chosen is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence of a medical display and video integration system, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic AI. Instead, they relate to characteristics being similar or superior to the predicate device and not introducing new safety/effectiveness issues.

• Display validation tests
• Nexxis OR qualification tests
• System tests
  These tests are implicitly the "study" proving the device meets the characteristics. The document does not provide numerical results from these tests, only the conclusion that they showed similar or superior characteristics. |
  | Safety and Performance: No new issues of safety and effectiveness are revealed. | Met: "Bench testing... did not reveal new issues of safety and effectiveness." This is a qualitative assessment based on the bench testing. The document explicitly states: "Animal or clinical testing have not been performed." This is common for devices demonstrating substantial equivalence where bench testing sufficiently addresses the changes. |

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

• Sample Size: Not specified in terms of clinical cases or patient data. The "test set" for this device consists of the physical device components themselves undergoing bench testing. The testing is a series of engineering and performance tests on the hardware and software, not a study of patient data.
• Data Provenance: Not applicable in the sense of patient data. The tests were performed on the device components and system as engineered and manufactured by Barco N.V. (located in Kortrijk, Belgium, as indicated by the address). The tests are internal validation tests by the manufacturer.

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

• Not Applicable: For this type of device (medical display and video integrator), "ground truth" as typically understood in AI/ML or diagnostic studies (e.g., expert labels on images) is not relevant. The "ground truth" for the bench tests would be the engineering specifications and performance standards of the device. These are established by the manufacturer's engineers and quality assurance teams, not by medical experts interpreting data.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements in human expert labeling of data, especially in diagnostic tasks. Since the "test set" involves bench testing of hardware/software against engineering specifications, such adjudication is not performed. Test failures would be investigated and resolved by engineering and quality teams.

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

• No: The document explicitly states: "Animal or clinical testing have not been performed." An MRMC study is a type of clinical study involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This was not required or performed for this 510(k).

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

• Not Applicable in the traditional sense of a diagnostic algorithm: While the device's components (e.g., Nexxis Compositor MNC-180 for video composition) perform algorithmic functions, this is not a diagnostic AI algorithm that operates "standalone" to produce a medical finding. Its "standalone" performance would be its ability to correctly process and display video signals according to specifications, which is covered by the bench tests.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for proving substantial equivalence here relies on demonstrating that the device's technical specifications and measured performance (e.g., display quality, video processing capability, signal latency) meet or exceed those of the predicate device, and that it reliably performs its intended function of video integration and display. This is verified through objective bench testing.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its functionality is hard-coded or configured based on engineering design.

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

• Not Applicable: As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

In summary, the provided document describes a 510(k) submission for a non-AI/diagnostic medical device (a display and video integration system). The "acceptance criteria" and "studies" are framed within the context of demonstrating substantial equivalence to a predicate device through engineering bench testing rather than clinical performance studies using patient data or AI/ML algorithms.

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The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners.

It is specially designed for breast tomosynthesis applications.

MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP display, specifically addressing the requirements of the emerging modality of Digital Breast Tomosynthesis (DBT) and QA software.
The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant.
The display uses LED backlight technology.

The provided text describes a 510(k) Summary for the Barco Mammo Tomosynthesis (MDMG-5221) device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through extensive clinical studies.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify formal "acceptance criteria" in the sense of performance thresholds for a clinical study (e.g., a specific sensitivity or specificity target). Instead, it compares the technical specifications and performance of the new device to its predicate. The "acceptance criteria" can be inferred as demonstrating comparable or superior performance in key technical aspects and safety as the predicate device.

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

The document explicitly states: "Animal or clinical testing have not been performed." Therefore, there is no test set of patient data, sample size, or data provenance from a clinical study to report. The "testing" referred to in the document is bench testing of the display device itself.

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

Not applicable, as no clinical test set with medical images requiring expert ground truth was used in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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 display monitor, not an AI-powered diagnostic tool. The submission does not involve an MRMC study or AI assistance.

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

Not applicable. This device is a display monitor, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the technical performance tests would be the established engineering specifications and measurement standards.

8. The Sample Size for the Training Set

Not applicable. As this is a display monitor submission demonstrating substantial equivalence via technical bench testing, there is no "training set" in the context of an algorithm or AI.

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

Not applicable. There is no training set mentioned or implied in this submission for this device.

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The MDMC - 12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners.

It is especially designed for breast tomosynthesis (3D mammography) applications, breast US.

It is especially designed for CT and ultrasound including vascular and gynecological US.

Not Found

The provided document is an FDA 510(k) clearance letter for the Barco Coronis Uniti, a Picture Archiving and Communications System (PACS) display device. This document confirms the device's substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics that "prove the device meets the acceptance criteria."

The clearance letter focuses on regulatory approval, stating that the device is substantially equivalent to existing devices and is subject to general controls. It does not include the technical detail and study results typically found in a clinical or performance evaluation report.

Therefore, I cannot fulfill your request for the tables and information based solely on the provided text, as this information is not present. The document explicitly states its purpose is to grant clearance for marketing based on substantial equivalence, not to provide a detailed performance study report.

To answer your questions, I would need a different type of document, such as a formal clinical study report, a performance validation report, or a summary of safety and effectiveness data (SSED) that would typically accompany a 510(k) submission but is not included in this clearance letter.

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The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted for the SIVR56-T KIT.

The document is an FDA 510(k) clearance letter for the SIVR56-T Kit, classifying it as substantially equivalent to a predicate device. It specifies the regulation number (21 CFR 870.2450) and regulatory class (Class II) for a medical cathode-ray tube display. It also includes the "Indications for Use" statement, which describes the device's purpose: "The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display."

The document discusses regulatory compliance, labeling, and reporting requirements, but does not contain any data, studies, or acceptance criteria related to the device's performance.

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The MDMC-12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis applications.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to BARCO N.V. concerning their device MDMC-12133, a Picture Archiving and Communications System (PACS). The letter indicates that the device is intended for displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis, with a special design for breast tomosynthesis applications.

However, the document is an FDA approval letter and does not contain the detailed study information necessary to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. The letter confirms substantial equivalence to a predicate device and states the intended uses but does not include the underlying technical or clinical validation studies.

Therefore, I cannot provide the requested information based solely on this document. To answer your questions, additional documentation such as the 510(k) submission summary, a clinical study report, or a detailed technical specification document would be required.

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The NIO 2MP LED Display (MDNC-2221) is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Nio Color 2MP (MDNC-2221)

The provided text is a 510(k) premarket notification letter from the FDA to Barco N.V. regarding their Nio Color 2MP display. This document does not contain information about the acceptance criteria for a device's performance or a study proving it meets those criteria.

The letter is primarily a regulatory approval document, stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for displaying and viewing digital images by trained medical practitioners (excluding primary image diagnosis in mammography). It outlines the regulatory classification, applicable regulations, and general controls the manufacturer must adhere to.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present.

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