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-- C822W
This Medical Monitor 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.

-- C1216W
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

-- C821W
This Medical Monitor is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

C1216W is 31 inch TFT color LCD monitor, C822W and C821W are 31.5 inch TFT color LCD monitor, they are intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

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. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets 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.

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The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.

The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.

The MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems.

The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply.

This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical LCD monitor (MDEC-2523). It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to regulatory standards.

Crucially, this document does not include information about a study proving the device meets acceptance criteria related to a clinical performance claim, specifically one involving AI, human readers, or ground truth establishment based on expert consensus, pathology, or outcomes data.

The acceptance criteria and study described in the input prompt are typically associated with devices that make diagnostic or therapeutic claims based on analyzing medical images or data, often involving AI or software. This document is for an LCD monitor, which is a display device. Its performance is assessed through electrical safety, EMC, environmental, and software testing to ensure it correctly displays images without introducing new safety or effectiveness concerns, rather than evaluating its accuracy in diagnosing conditions or improving human reader performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study as outlined in the prompt's nine points because the provided text does not contain this type of study information.

The non-clinical performance testing conducted for this device, as stated in the document, includes:

• Electrical safety testing (ANSI AAMI E560601-1)
• EMC testing (IEC 60601-1-2 Edition 4.1)
• Environmental testing (Climate, shock and vibration, packed, thermal analysis)
• Software testing
• Usability/human factors

The document explicitly states: "Clinical study - Not Applicable." This further confirms that the type of study outlined in the prompt (involving expert consensus, mrmc, standalone performance etc.) was not performed or required for this device.

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C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP LCD Monitors C310S, G310S, C316S, G316S 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 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, 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. 6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography.

This product has 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 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets 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.

C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle.

G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle.

C310S and G310S have the same main board and design principle.

C316S and G316S have the same main board and design principle.

The provided text describes a 510(k) summary for several LCD medical displays (C310S, G310S, C316S, G316S, C616W) which are claimed to be substantially equivalent to a previously cleared device (K240310). The information does not detail an AI-powered device or a study involving human readers or comparative effectiveness for AI assistance. Instead, it focuses on the technical specifications and performance of the LCD monitors.

Therefore, the following information is extracted and parts that are not relevant to an AI/ML powered device or are not provided in the text are explicitly stated as such.

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

The acceptance criteria are implied by the "Description" column, indicating what was measured, and the "Test result" column, which uniformly states "PASS". This suggests that the measured performance met the predetermined criteria for each test.

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 tests performed are physical laboratory tests on the display embedded software using DBI Calibration Feedback System on the monitors, not a test on a test set of medical cases.

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 provided as the device is an LCD monitor, not an AI / image analysis software requiring expert annotation for ground truth. The tests are technical performance evaluations of the display.

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

This information is not provided as it's not relevant for the type of device being described (an LCD 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI or AI-assisted diagnostic tool.

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

No, a standalone performance study was not done as this device is an LCD monitor, which is a display hardware, not an algorithm.

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

The ground truth for the performance tests of the LCD monitors is based on pre-determined technical criteria and industry standards (e.g., DICOM Part 3.14, AAPM Task Group 18 guideline, manufacturer's typical data). This is not a "ground truth" derived from medical diagnosis but from established engineering and display performance metrics.

8. The sample size for the training set

This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set.

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

This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set and ground truth generation.

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C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP LCD Monitors C310S, G310S, C316S, G316S 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 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, 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.

6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography. This product has 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 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets 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.

C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle. G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle. C310S and G310S have the same main board and design principle. C316S and G316S have the same main board and design principle.

The provided text describes K240310 for Shenzhen Beacon Display Technology Co., Ltd.'s LCD Monitors (C310S, G310S, C316S, G316S, C616W) but does not contain acceptance criteria or study details regarding AI/algorithm performance.

The submission focuses on establishing substantial equivalence to predicate devices through technical comparisons and bench testing of display characteristics. There is no mention of an AI/algorithm component requiring performance studies with human readers, ground truth establishment, or clinical evaluations.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving it meets them, as the provided text pertains to LCD monitors themselves, not an AI component.

The document does contain the following relevant information regarding the LCD monitors' performance:

The performance testing was done via bench tests and focused on the display characteristics of the monitors.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail form with numerical targets. Instead, it states that the devices (C310S, G310S, C316S, G316S, C616W) were tested to verify "display characteristics equivalent to those of the predicate devices" and that they "meet DICOM Part 3.14 and other standards." The reported performance is implicitly shown through the comparison tables (Tables 1, 2, and 3) by comparing the proposed devices with their respective predicate devices.

Here's an example of some performance characteristics from the provided tables. For a full list, please refer to the "General Comparison" tables in the original document.

Example Table of Reported Device Performance (Partial - C310S/C316S Color LCD Monitors):

Note: The "Explanation of Differences" column in the original tables addresses specific instances where the proposed device's performance differs numerically from the predicate but is considered substantially equivalent (e.g., "Different Panel" or "Different design scheme" for brightness/contrast differences, which are then justified by passing TG18 guideline tests).

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

• Sample Size: Not specified. The document states "the bench tests were performed on C310S, G310S, C316S, G316S, C616W," implying one or more units of each model. It does not mention a large sample size of images or cases, as this is a device for displaying images, not an image analysis algorithm.
• Data Provenance: Not applicable in the context of image data. The testing was conducted on the physical monitors themselves, measuring their optical characteristics.

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

• Not applicable. The ground truth for evaluating display performance is based on established technical standards (e.g., DICOM Part 3.14, AAPM TG18 guideline) and objective measurements, not subjective expert interpretation of medical images on the device.

4. Adjudication method for the test set:

• Not applicable. Performance was assessed against objective technical specifications and standards using bench tests, not through human adjudication of diagnostic outcomes.

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 is not an AI device. The submission does not describe an MRMC study.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Technical Standards and Objective Measurements: The "ground truth" for the display devices' performance is their conformance to established industry standards like DICOM Part 3.14 and the AAPM Task Group 18 (TG18) guideline for assessment of display performance. This includes measurements of spatial resolution (MTF), pixel defects, luminance characteristics (maximum, minimum, achievable, recommended), DICOM GSDF conformance, and color tracking.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set was used.

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HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.

This document describes the performance assessment of medical LCD monitors (HMD3C21S and HMD5G21S) for displaying radiological images. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical effectiveness of an AI algorithm. Therefore, many of the requested elements typically found in AI/ML medical device evaluations (like sample sizes for training/test sets, expert adjudication, MRMC studies, or specific performance metrics using AI) are not applicable or available in this submission.

The "acceptance criteria" here refers to the performance benchmarks for a medical display, ensuring it meets standards for diagnostic imaging. The "study that proves the device meets the acceptance criteria" refers to the bench testing performed on the monitors.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various physical laboratory measurements performed on the monitors to ensure they meet the display requirements. The acceptance criteria are implicit in the tests performed, aiming for performance comparable to existing medical displays. The reported performance is generally "By reporting [method]" or "Measure the [property]", indicating that these measurements were taken rather than providing specific numerical results for each one. This type of submission focuses on demonstrating that the testing was done according to recognized standards.

Implicit Acceptance Criteria (based on tests performed): The monitors must demonstrate adequate performance across these parameters consistent with established medical display standards (e.g., AAPM-TG18, IEC).

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of diagnostic performance testing with cases. This submission is for a medical monitor, not an AI diagnostic algorithm. The "testing" refers to the physical bench testing of the device itself.
• Data Provenance: No patient data or clinical images are referenced for the performance testing of the monitor. The testing relates to the physical characteristics and display capabilities of the monitor hardware.

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

• Not Applicable. This document is for a medical display device, not an AI algorithm that requires setting ground truth for image interpretation. The "ground truth" for a monitor's performance is established by objective physical measurements against industry standards (e.g., AAPM-TG18).

4. Adjudication method for the test set

• Not Applicable. As no diagnostic performance with images and human readers is being evaluated, no adjudication method is relevant.

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 is a medical monitor, not an AI-powered diagnostic device. No MRMC studies were conducted as part of this submission.

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

• Not Applicable. This is a monitor, not an algorithm. Therefore, standalone performance (in the context of an algorithm's diagnostic output) is irrelevant.

7. The type of ground truth used

• Objective Physical Measurements against Industry Standards. The "ground truth" for a display device is its adherence to performance specifications and established industry standards (e.g., DICOM GSDF, AAPM-TG18), verified through physical and optical measurements using specialized equipment.

8. The sample size for the training set

• Not Applicable. This device is a medical monitor, not an AI/ML algorithm that requires a 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, no ground truth needed to be established in that context.

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BenQ LCD monitor (MD310C, MD310G and MD210G) 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.

BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).

The provided document is a 510(k) premarket notification for a medical LCD monitor (MD310C, MD310G, MD210G). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study as seen with novel high-risk devices.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for image quality parameters or a direct measure of device performance against such criteria. Instead, it states that "All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device." (Section 5.8)

The comparison tables (starting on page 5) show the specifications of the subject device (BenQ LCD Monitor) against three predicate devices. These specifications implicitly act as the "performance" for this type of device, and the "acceptance criteria" is that the differences do not adversely impact safety and effectiveness.

Here's a summary of the key performance parameters compared, with the understanding that "acceptance" for this submission means demonstrating that differences do not present new safety/effectiveness concerns:

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). Therefore, there is no clinical test set, sample size, or data provenance from patient data for this submission. The "test set" for this device consists of the physical units undergoing non-clinical engineering and performance testing. The provenance of this would be internal to BenQ's testing facilities (Taiwan, based on the submitter's address).

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

Since no clinical test data was used, there was no ground truth based on patient images established by medical experts for this submission. The "ground truth" for non-clinical tests would be defined by engineering standards and specifications, validated by internal company experts (e.g., engineers, quality control personnel). No specific number or qualifications of these internal experts are mentioned.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical test data was used (Section 5.9).

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

This device is an LCD monitor, not an AI algorithm. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable. The device's performance is its ability to accurately and reliably display medical images as intended. This performance was evaluated through non-clinical testing (reliability, software validation, electromagnetic compatibility, electrical safety, function test, usability test – Section 5.8).

7. The Type of Ground Truth Used

For non-clinical testing, the "ground truth" would be the engineering specifications, industry standards, and regulatory requirements (e.g., electrical safety standards, image display quality standards relevant to medical monitors). These are deterministic and measurable, without requiring expert consensus on clinical findings.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (LCD monitor), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of Approach:

The BenQ LCD Monitor K170944 submission followed the Traditional 510(k) pathway which relies on demonstrating substantial equivalence to existing predicate devices. For a medical display monitor, this involves comparing technical specifications and proving through non-clinical laboratory tests (reliability, safety, function, usability) that any differences from the predicate devices do not adversely affect the safety or effectiveness of the device for its intended use. Clinical studies are typically not required for this type of device unless there are significant technological differences that could introduce new questions of safety or efficacy.

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The LCD monitor is intended to be used by trained professionals as a fMRI viewing monitor within the MR environment.

This device must not be used for a life support system. This device must not be used for diagnostics.

The LCD Monitor is designed for the purpose of viewing images for MRI applications within the MR environment. The high resolution panels combined with high performance image processing controller, provides the users extremely high definition and high quality medical image displays. The monitor comply with international EMC and safety standards for medical devices.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested.

The document is a 510(k) premarket notification for an "LCD Monitor" from Nordic NeuroLab AS. It discusses the regulatory classification, intended use, and substantial equivalence to a predicate device. It mentions compliance with safety and EMC standards and "performance testing" but does not detail:

• Specific performance acceptance criteria (e.g., minimum brightness, contrast ratio, resolution accuracy with quantitative thresholds).
• Reported device performance against those criteria.
• Details about a study proving the device meets those criteria, such as sample size, data provenance, expert involvement, or ground truth establishment methods.
• Information related to AI product development and validation, such as MRMC studies, standalone performance, training set details, or ground truth for training.

The document primarily focuses on regulatory compliance for a medical device that is a specialized monitor, not an AI/ML-driven diagnostic or image processing device. The "Performance Testing" section states that the device meets design and performance specifications but does not provide details of how this was demonstrated or what those specifications quantitatively were.

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Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used in displaying for diagnosis of X-ray or MRI, etc.

46 cm (18.1 inch) Monochrome LCD Monitor, RadiForce G11 53 cm (20.8 inch) Monochrome LCD Monitor, RadiForce G31 54 cm (21.3 inch) Monochrome LCD Monitor, RadiForce G51

This document is a 510(k) premarket notification letter from the FDA regarding the RadiForce G11, G31, and G51 monochrome LCD monitors for medical imaging. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the substantial equivalence of these monitors to legally marketed predicate devices and their general indications for use.

Therefore, I cannot extract the requested information from the provided text.

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