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8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display.

The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.

For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.

C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.

The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.

The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Shenzhen Beacon Display Technology Co., Ltd.'s 8MP Color LCD Displays (C811W, C811WT, PA27, PA27T).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Test" column, and the reported device performance is presented in the "C811W", "C811WT", "PA27", and "PA27T" columns. The predicate device (Barco MDPC-8127) is also listed for comparison of technological characteristics.

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

The document does not explicitly state a sample size in terms of a number of distinct display units tested within each model group (C811W, C811WT, PA27, PA27T). The results are presented as single values for each model, implying that these are representative measurements from the tested devices.

The data provenance is from bench testing conducted on the newly submitted devices and compared against the specifications of a predicate device. Regarding country of origin, the manufacturer is Shenzhen, Guangdong, China. The testing itself would likely have been performed in a lab setting, possibly in China or by a certified testing facility collaborating with the manufacturer. The document does not specify if the data is retrospective or prospective, but as it's for a 510(k) submission, it would be considered prospective with respect to the regulatory approval process.

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

This information is not applicable as the study described is a technical performance assessment of display characteristics, not a clinical study involving human interpretation of medical images or ground truth established by medical experts. The "ground truth" for these tests are objective, measurable physical properties of the displays, governed by established test methods and standards (e.g., IDMS 1.03).

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases, and a process is needed to resolve discrepancies. This document describes objective bench testing.

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, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance of a medical display, not a clinical diagnostic aid involving AI or human reader performance.

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

This is not applicable. The device is an LCD display, not an algorithm. Its "performance" is its ability to accurately render visual information, which is evaluated through the technical tests detailed.

7. The type of ground truth used

The ground truth used for this technical performance assessment is based on objective measurements of physical display characteristics as defined by industry standards, specifically the "TPA Guidance" and "IDMS 1.03" (International Display Measurement Standard). Examples include:

• Pre-defined target luminance (e.g., 500 cd/m²)
• Reference sRGB color space
• Calibrated measurement equipment to determine values like MTF, pixel defect counts, deviation percentages, and color errors against established benchmarks.

8. The sample size for the training set

This information is not applicable. The device is a hardware display, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as #8.

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C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

The provided text describes a 510(k) premarket notification for medical display monitors and does not contain information about the acceptance criteria and study proving device meets the criteria. This document focuses on demonstrating substantial equivalence to a predicate device through comparison tables and performance testing rather than defining acceptance criteria and presenting a study with specific performance metrics against those criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets the acceptance criteria based on the provided text.

Here's why the requested information is not available:

1. Acceptance Criteria and Reported Device Performance: While the document presents detailed technical specifications of the proposed devices (e.g., resolution, contrast ratio, maximum luminance, DICOM calibrated luminance) and compares them to a predicate device, it does not explicitly state these specifications as "acceptance criteria" against which a study's results are evaluated. The document focuses on showing that the proposed device's characteristics are comparable to or within an acceptable range of the predicate device's characteristics. There is no specific table labeled "acceptance criteria" and "reported device performance."

2. Sample Size and Data Provenance for Test Set: Performance testing was conducted, but the document does not mention a "test set" in the context of clinical images or patient data. The tests are bench tests on the display monitors themselves (e.g., measuring luminance, uniformity, response time). Therefore, there is no sample size for an image-based test set or data provenance (country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth: Since the performance testing comprises bench tests on the display's physical and optical characteristics, there is no "ground truth" derived from expert interpretation of medical images. The evaluation is based on technical measurements.

4. Adjudication Method: Not applicable, as there are no expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states: "No animal or clinical testing is needed for C510S, CB5MP, MB5MP, C516S, G516S." Therefore, no MRMC study or human reader performance evaluation (with or without AI assistance) was performed.

6. Standalone (Algorithm Only) Performance: This is a medical display monitor, not an AI algorithm. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used: The ground truth for the performance testing consists of technical standards and measurements (e.g., DICOM Part 3.14, AAPM TG18 guideline measurements) for display characteristics. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set: Not applicable. These are display monitors, not an AI model that requires a training set.

9. How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

The document primarily demonstrates substantial equivalence to a predicate device based on technical specifications and adherence to relevant industry standards for display performance in diagnostic radiology, as outlined in the bench tests described.

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These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.

C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.

C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.

For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.

The provided document describes the 510(k) premarket notification for Shenzhen Beacon Display Technology Co., Ltd.'s 4MP/8MP Color LCD Monitors (C44W+/C82W+, C83W+, C85W+). These monitors are intended for displaying digital images for review and analysis by trained medical practitioners, excluding mammography images for diagnosis.

The study presented is a bench test comparison to a legally marketed predicate device, the Eizo Nanao Corporation RadiForce RX440 (K130070). The purpose of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to establish the device's absolute performance against a set of clinical acceptance criteria for diagnosis.

Here is an analysis based on your requested information, referencing the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study targeting specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating equivalence to a predicate device based on technical display characteristics and conformance to relevant industry guidelines (AAPM Task Group 18 (TG18 guideline)).

The "reported device performance" are the results of the bench tests on the proposed devices (C44W+, C82W+, C83W+, C85W+) showing their technical specifications and how they align with or differ from the predicate device. The document generally concludes that the devices are equivalent to the predicate.

Here's a summary of key performance tests conducted, which serve as the basis for their claim of equivalence:

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

The study involves bench testing of the devices themselves (C44W+, C82W+, C83W+, C85W+). It's not a study involving patient data or human interpretation. Therefore, "sample size" and "data provenance" in the context of clinical images or patient data are not applicable. The "test set" consists of the physical display units being evaluated.

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

This is a technical performance study of a device (monitor), not a diagnostic accuracy study using medical images interpreted by experts. Therefore, "ground truth" in the context of expert consensus on medical images is not applicable. The ground truth is adherence to technical specifications and industry standards like AAPM TG18. The "experts" involved would be the technical personnel performing the bench testing and evaluating the results against established standards, but their specific number and qualifications are not mentioned in this document.

4. Adjudication method for the test set

"Adjudication method" is not applicable as this is a technical performance study of display monitors, not an evaluation of diagnostic interpretations where consensus among readers would be required.

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, an MRMC comparative effectiveness study was not done. This submission is for medical display monitors, not an AI-powered diagnostic tool. The document focuses on the technical characteristics and equivalence of the monitors to a predicate device.

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

This question refers to AI algorithm performance. Since the device is a medical display monitor and not an AI algorithm, a standalone performance study in that context was not done. The study performed was a technical assessment of the monitor's display capabilities.

7. The type of ground truth used

The "ground truth" for this technical assessment is adherence to technical specifications, industry standards (e.g., DICOM 3.14, AAPM TG18 guidelines), and comparison with the predicate device's established performance. It's not based on pathology, expert consensus on medical images, or patient outcomes data.

8. The sample size for the training set

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, a "training set" is not applicable.

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

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, the concept of establishing ground truth for a training set is not applicable.

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The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.

The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.

Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.

The provided document is a 510(k) Pre-Market Notification for medical display monitors (3MP Color LCD Monitors C32S+, C32SP+ and 3MP Monochrome LCD Monitors G32S+, G32SP+). It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific clinical acceptance criteria for an AI-powered device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable or not present in this type of submission. This document describes the technical specifications and bench test results of the monitors themselves, not the performance of an AI algorithm based on image interpretation.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria" in a pass/fail table format for an AI algorithm's performance. Instead, it lists technical specifications of the proposed monitors and compares them to predicate devices, along with bench test results to verify compliance with display standards. The performance reported relates to display characteristics, not diagnostic accuracy of an AI.

However, we can infer some "acceptance criteria" based on the comparison tables and testing performed, which are primarily related to meeting technical standards for medical displays.

Note: Specific numerical results for each measurement (e.g., exact luminance non-uniformity values) are not provided in this summary, but the document states they were measured and found to be equivalent to predicate devices.

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 applicable as the document describes tests on the physical display monitors, not an AI algorithm processing medical images. The "test set" here refers to the monitors themselves.

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. The "ground truth" for these display monitors is defined by technical specifications and adherence to standards like DICOM and AAPM TG18 guidelines, measured by equipment and engineering assessments, not by expert medical image interpretation.

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

This information is not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or AI output, not for technical verification of display monitors.

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. This document is for medical display monitors and does not involve AI assistance or MRMC studies for diagnostic performance improvement.

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

This information is not applicable. No algorithm is being evaluated in this submission.

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

The "ground truth" for the performance evaluation of these medical displays is established by adherence to technical and performance standards for display devices, such as DICOM Part 3.14 and AAPM Task Group 18 (TG18 guideline) for display performance. It's measured through physical bench testing and comparison to established engineering specifications and predicate devices.

8. The sample size for the training set

This information is not applicable. There is no AI algorithm with a training set being described in this document.

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

This information is not applicable. There is no AI algorithm with a training set being described in this document.

In summary, the provided text is a 510(k) summary for medical display monitors, focusing on their technical specifications and substantial equivalence to predicate devices, as demonstrated through bench testing against established display standards. It does not contain information related to AI algorithm performance or clinical studies of diagnostic accuracy.

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The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.

C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/ grayscale monitors. They are specifically designed to provide the high definition image outputs for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices (2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+) are primarily established through performance testing against the AAPM Task Group 18 (TG18) guideline and comparison with predicate devices.

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

The provided text does not specify the exact sample size for the test set. It mentions "bench tests were performed on C22S+, C22SP+, G22SP+, G22SP+, G23SP+" for multiple devices (six models in total). It implies one or more units of each model were tested.

The data provenance is not explicitly stated. However, since the submitter is Shenzhen Beacon Display Technology Co., Ltd. in China, it is highly likely that the testing was conducted in China or under their direct supervision. The study appears to be retrospective as it's a premarket notification for devices seeking substantial equivalence to already cleared predicate devices.

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

This information is not provided in the document. The acceptance criteria relate to technical performance specifications of the monitors themselves (e.g., luminance, resolution), not diagnostic accuracy based on expert interpretation of medical images displayed on them. Therefore, there's no mention of experts establishing a ground truth for diagnostic accuracy in this context.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are technical performance evaluations of the monitors, not diagnostic studies requiring expert adjudication of image interpretations.

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 done. The devices are medical monitors, not AI algorithms, so this type of study is not relevant to their regulatory clearance in this context.

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

No, a standalone algorithm performance study was not done. The devices are medical monitors, which display images for human interpretation, they are not algorithms.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on technical specifications and measurable performance according to established industry standards, specifically the AAPM Task Group 18 (TG18) guideline for assessing display performance for medical imaging systems. This involves quantifiable measurements of display characteristics rather than clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. As these are medical display monitors, there is no "training set" in the context of machine learning or AI algorithms. The monitors are hardware devices.

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

This information is not applicable, as there is no training set for these devices.

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The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen. Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.

The document describes the premarket notification (510(k)) for Shenzhen Beacon Display Technology Co., Ltd.'s 5MP Color and Monochrome LCD Monitors (C53S+, C53SP+, G53S+, G53SP+). However, this document does not contain information about an AI/algorithm-driven device, nor does it detail a study proving adherence to specific acceptance criteria for such a device in the context of AI model performance. Instead, it focuses on the substantial equivalence of the monitors to a predicate device, primarily through bench testing of display characteristics.

Therefore, I cannot provide the requested information as it pertains to an AI/algorithm efficacy study, acceptance criteria for an AI model, sample sizes, expert involvement, or MRMC studies, because this document is about medical display monitors and their technical specifications, not an AI software or algorithm.

The document states:

• Device Type: 5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+. These are hardware display devices, not AI algorithms.
• Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM." This reinforces that the device is a display and not an AI component.
• Performance Testing: The "Performance Testing" section (page 16) outlines the tests conducted on the monitors themselves, such as "conformance to DICOM GSDF," "calibrated luminance," "luminance non-uniformity," "chromaticity non-uniformity," "temporal response," "spatial noise," "reflection coefficient," "veiling glare," and "spatial resolution." These are all standard display performance tests.
• No clinical or animal testing: The document explicitly states "No animal or clinical testing is needed for C53S+, C53SP+, G53S+, G53SP+." This further confirms that no studies involving human or animal subjects (which would be typical for evaluating an AI's impact on diagnostic performance) were conducted or required.

The request's parameters (acceptance criteria for an AI model, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the content of this document.

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The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography. With built-in multi-display modes, the monitor facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.

The provided text describes the 510(k) summary for the Shenzhen Beacon Display Technology Co., Ltd.'s 6MP Color LCD Monitor (C61W+). It outlines the device's technical specifications and compares it to a predicate device, the EIZO Corporation's 6MP Color LCD Monitor, RadiForce RX650 (K134002).

However, this document does not contain information related to an AI/ML-based medical device study. The device in question is a medical display monitor, and the "acceptance criteria" and "study" described are focused on verifying its display performance characteristics (e.g., DICOM conformance, luminance, chromaticity, pixel defects) against established standards (AAPM TG18 guideline) and demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria for an AI/ML product, as the provided text is about a display monitor and not an AI/ML medical device.

The document does mention performance tests done on the monitor to show its equivalence to the predicate device. Here's what can be extracted from the provided text about the monitor's performance testing:

Device: 6MP Color LCD Monitor (C61W+)

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

The document doesn't present precise quantitative "acceptance criteria" in a table format for each test, but it states that "The test results showed that C61W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX650 except some items, each of which was determined that it would not affect observer's performance."

Here's a summary of the performance tests mentioned, which implicitly define the "acceptance criteria" as conforming to the specified standards or demonstrating equivalence to the predicate:

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

• Sample Size: Not specified. The summary implies testing was done on the C61W+ monitor itself, likely one or a few units, rather than a "test set" of images or patient data.
• Data Provenance: Not applicable as it's a display monitor, not an AI/ML algorithm processing data. The tests are physical measurements and visual inspections of the monitor.

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

• Not applicable. Ground truth, in the context of an AI/ML device, refers to disease presence/absence or other clinical labels. For a display monitor, the "ground truth" is adherence to technical specifications and established display standards (e.g., DICOM GSDF). The "experts" would be the engineers and technicians performing the measurements and visual checks, trained in display calibration and quality control. Their number and specific qualifications are not detailed in this summary.

4. Adjudication method for the test set:

• Not applicable. This concept is relevant for human-in-the-loop or expert consensus for AI/ML algorithm evaluation, not for physical device testing of a monitor.

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. This study type is for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for a medical display monitor.

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

• Not applicable. This is for AI/ML algorithms, not for a display monitor. The performance tests mentioned (DICOM conformance, luminance, etc.) are "standalone" in the sense they evaluate the device itself.

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

• The "ground truth" for a medical display monitor is its adherence to industry standards for display quality, such as:
  • AAPM TG18 guideline: For display performance assessment (DICOM GSDF conformance, luminance, chromaticity non-uniformity, artifacts).
  • FDA Staff Guidance: Display Accessories for Full-Field Digital Mammography Systems: For specific chromaticity measurements.
  • Internal specifications for pixel defects/faults.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm being trained for this device.

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

• Not applicable. There is no AI/ML algorithm being trained for this device.

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The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.

Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.

The provided text describes a 510(k) premarket notification for a medical display monitor, not an AI/ML-driven device. Therefore, the information typically required to describe acceptance criteria and a study proving an AI/ML device meets those criteria (e.g., sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

The document focuses on demonstrating substantial equivalence of the Beacon 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) to predicate devices (EIZO RadiForce GX240 and RX250/RX250-AR). This is done by comparing:

• Intended Use: Showing it's identical to the predicate devices (displaying digital images for review, analysis, and diagnosis by trained medical practitioners, excluding mammography).
• Technological Characteristics: Comparing specifications like screen technology, resolution, brightness, contrast ratio, inputs, etc., and explaining that any differences do not affect safety or effectiveness.
• Performance Testing (Bench Tests): These tests are conducted on the device itself to verify its physical display characteristics against established guidelines (AAPM TG18), and not really a study assessing diagnostic performance assisted by AI.

To directly answer your request based on the provided document:

There is no information in this document about:

1. A table of acceptance criteria and reported device performance for an AI/ML device. The "Performance Testing" section describes bench tests on the display's physical characteristics, not diagnostic performance metrics for an AI system.
2. Sample sizes used for a test set and data provenance: No AI/ML test data or patient data is mentioned. The "test set" here refers to the actual monitor units undergoing bench tests.
3. Number of experts used to establish ground truth and qualifications: Not applicable for a display monitor's bench testing.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted as this is a display monitor, not an AI assistance tool.
6. Standalone (algorithm only without human-in-the-loop) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic "ground truth" for AI. The "ground truth" for the display itself would be defined by performance standards like DICOM GSDF and TG18 guidelines.
8. Sample size for the training set: Not applicable as there is no AI/ML training involved.
9. How ground truth for the training set was established: Not applicable.

Summary of Device Performance (from "Performance Testing" section):

The document states that the bench tests performed on the G22S+, G22SP+, C22S+, C22SP+ include:

• Verification of conformance to DICOM GSDF (in accordance with AAPM TG18 guideline).
• Measurement of luminance non-uniformity characteristics (TG18 guideline).
• Measurement of chromaticity non-uniformity characteristics (TG18 guideline).
• Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance.
• Visual check for miscellaneous artifacts (TG18 guideline).
• Measurement of spatial resolution (MTF).
• Maximum number allowed for each type of pixel defects/faults.

Reported Device Performance:

The document broadly states: "The test results showed that G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device... each of which was determined that it would not affect observer's performance." Specific numerical acceptance criteria and the exact measured values are not provided in this excerpt, only the types of tests performed and the general conclusion of equivalence.

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The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 8MP Color LCD Monitor (C81W+), structured to address your specific points.

Acceptance Criteria and Device Performance Study for 8MP Color LCD Monitor (C81W+)

The provided document describes a 510(k) premarket notification for the 8MP Color LCD Monitor (C81W+), comparing it to a predicate device, the EIZO RadiForce RX850. The core of the acceptance criteria and the study lies in demonstrating substantial equivalence to the predicate device, particularly in performance characteristics relevant to medical image display.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily relies on comparing the technological characteristics of the proposed device (C81W+) with the predicate device (RadiForce RX850) and then validating these characteristics through bench testing against established guidelines. The "acceptance criteria" are implicitly set by the performance of the predicate device and the standards outlined in the AAPM Task Group 18 (TG18 guideline).

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

The document explicitly states: "No animal or clinical testing is needed for C81W+." This means there was no "test set" of patient data in the traditional sense involving medical images for diagnostic performance evaluation. The "test set" here refers to the device itself undergoing various technical bench tests.

• Test Set Sample Size: N/A (as it refers to the device undergoing technical tests, not a dataset of medical images).
• Data Provenance: The data comes from bench testing performed on the C81W+ device, following guidelines like AAPM TG18. The country of origin for the device manufacturer is Shenzhen, China. The testing itself is implied to be conducted by or for Shenzhen Beacon Display Technology Co., Ltd.

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

Since no clinical or retrospective patient data was used, there were no experts establishing "ground truth" for a medical image test set in this context. The "ground truth" for the device's technical specifications is established by internationally recognized standards (like DICOM GSDF, AAPM TG18 guideline) and the specifications of the legally marketed predicate device. The experts involved would be engineers or technicians with expertise in display technology and medical imaging standards, who conducted the bench tests and validated conformance. Their specific number and qualifications are not detailed in this premarket notification.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication by medical experts.

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

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states "No animal or clinical testing is needed for C81W+." This type of study would involve human readers evaluating cases with and without AI (or in this case, a new display) and comparing their diagnostic performance.

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

Not applicable. The device is a display monitor, not an AI algorithm. Therefore, a "standalone algorithm performance" study is irrelevant here. The performance evaluated is the technical display characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on:

• Technical specifications derived from established standards (e.g., DICOM GSDF, AAPM TG18).
• Performance data of a legally marketed predicate device (EIZO RadiForce RX850).
• Physical measurements obtained during bench testing of the C81W+ device.

8. The Sample Size for the Training Set

Not applicable. This device is a display monitor, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.

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