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This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.

The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).

There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.

Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX570.

RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.

The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document discusses the technical performance of a display monitor, such as:

• Spatial resolution (MTF)
• Pixel defects
• Luminance and chromaticity (including DICOM GSDF conformance)
• Temporal response
• Noise (NPS)
• Display reflections
• Small-spot contrast ratio

These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.

Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.

The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.

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RadiForce MX317W-PA is 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.

RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of 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 this product. The display is not intended for use with digital images from frozen section, cytology, or non- formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

"Patho" is for intended digital pathology use mode.

The provided FDA 510(k) clearance letter for the RadiForce MX317W-PA describes a display device for digital histopathology. It does not contain information about an AI/ML medical device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (such as accuracy, sensitivity, specificity, MRMC studies, and ground truth establishment methods for large datasets) is not present in this document.

The document primarily focuses on the technical performance and equivalence of a display monitor to a predicate device. The "performance testing" section refers to bench tests validating display characteristics like spatial resolution, luminance, and color, not the clinical performance of an AI algorithm interpreting medical images.

Given the information provided, here's an analysis based on the actual content:

Based on the provided document, the RadiForce MX317W-PA is a display monitor, not an AI/ML medical device designed for image interpretation. Therefore, the acceptance criteria and study detailed below pertain to the display's technical performance and its equivalence to a predicate display, not to an AI algorithm's diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "the display characteristics of the RadiForce MX317W-PA meet the pre-defined criteria when criteria are set." However, the exact numerical acceptance criteria for each bench test (e.g., minimum luminance, pixel defect limits) are not explicitly listed in the provided text. The document only lists the types of tests performed and states that the device "has display characteristics equivalent to those of the predicate device" and "meet the pre-defined criteria."

Note: The document only states that these tests were performed and that the results show equivalence to the predicate device and that the device meets pre-defined criteria. It does not provide the specific numerical results or the exact numerical acceptance criteria for each test.

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

• Sample Size for Test Set: The document describes bench tests performed on a single device, the RadiForce MX317W-PA (it's a physical monitor, not a software algorithm processing a dataset). There is no mention of a "test set" in the context of a dataset of medical images.
• Data Provenance: Not applicable. The "data" here refers to the measured performance characteristics of the physical display device itself during bench testing, not patient data.

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

• Not applicable. The ground truth for a display monitor's technical performance is established by standardized measurement equipment and protocols, not by expert interpretation of images. The device itself is the object under test for its physical characteristics.

4. Adjudication Method for the Test Set

• Not applicable. This concept applies to human or AI interpretation of medical images, where discrepancies among readers or algorithms might need resolution. For physical device performance, measurements are generally objective.

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

• Not performed/Applicable. An MRMC study is designed to assess the performance of a diagnostic aid (like AI) on image interpretation by human readers. This device is a display monitor, not an AI algorithm. Its function is to display images, not to interpret them or assist human interpreters in a diagnostic decision-making process that would warrant an MRMC study.

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

• Not applicable. As stated, this is a display monitor, not an algorithm.

7. Type of Ground Truth Used:

• The ground truth for the display's performance tests would be metrology-based standards and calibration references (e.g., standard luminance values, colorimetry standards) against which the display's output is measured. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy studies.

8. The Sample Size for the Training Set

• Not applicable. This device is hardware; it does not involve training data or machine learning algorithms.

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

• Not applicable. No training set exists for this device.

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This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce RX570 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. There are two model variations, RX570 and RX570-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX570 is Anti-Glare (AG) treatment and that of the RX570-AR is Anti-Reflection (AR) coating. Two RX570 monitors mounted on a single stand configuration is available identified by with "MD" like RX570-MD and RX570-AR-MD. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX570. RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX70 and it's not a medical imaging software.

The provided document describes the EIZO RadiForce RX570; RadiForce RX570-AR medical display monitor and its substantial equivalence to predicate devices, the RadiForce RX560 and RadiForce GX540. It evaluates the device based on performance testing against predefined criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The bench tests below were performed on the RadiForce RX570 following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology' issued on September 28, 2022" and that "the display characteristics of the RadiForce RX570 meet the pre-defined criteria when criteria are set." However, it does not provide a specific table directly listing the acceptance criteria values alongside the measured device performance values.

Instead, it lists the types of measurements performed and provides a general statement about meeting predetermined criteria and equivalence to predicate devices. For example, for DICOM GSDF conformance, it states "Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)," implying that the device met the DICOM GSDF conformance criteria.

Therefore, a table cannot be fully generated with specific numeric acceptance criteria and performance data from the provided text. The document acts as a high-level summary of the testing performed and the conclusion reached.

For a comprehensive table, access to the full test report would be needed. Based on the general statements, the interpretation is that the device did meet the criteria for each test:

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

The document does not explicitly state a "sample size" for the test set in terms of number of devices or datasets. The testing appears to have been performed on the RadiForce RX570 device itself to assess its physical and technical characteristics.

The testing methods are described as "bench tests" performed "following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology'." This indicates the data provenance is from prospective bench testing conducted in a lab environment. There is no information about the country of origin of the data beyond the manufacturer being EIZO Corporation of Japan.

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

This information is not applicable to this submission. The device is a medical display monitor, not an AI or diagnostic software that requires human expert review to establish ground truth for performance evaluation in medical image interpretation. The "ground truth" for this device's performance is established by objective physical measurements based on industry standards and FDA guidance.

4. Adjudication Method for the Test Set

This information is not applicable. Since the performance evaluation relies on objective physical measurements and conformance to technical standards (e.g., DICOM GSDF, TG18 guidelines), there is no need for an adjudication method involving multiple experts.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic AI systems or CADe/CADx devices to evaluate their impact on human reader performance. The RadiForce RX570 is a display monitor, and its performance is evaluated by its technical specifications and adherence to display standards, not by its effect on human readers' diagnostic accuracy.

6. Standalone Performance

A standalone performance evaluation was done. The entire Section 7, "Performance Testing," describes the standalone (algorithm-only, or in this case, device-only) performance testing of the RadiForce RX570. The device's characteristics (e.g., resolution, luminance, DICOM conformance) were measured directly against established technical guidelines and standards.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily based on technical standards, physical measurements, and industry guidelines. Specifically, the document mentions:

• "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology"
• "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)"
• "DICOM GSDF" (Grayscale Standard Display Function)

8. Sample Size for the Training Set

This information is not applicable. The RadiForce RX570 is a physical display device, not an AI algorithm that undergoes training.

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

This information is not applicable for the same reason as above; there is no training set for a display monitor.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce RX670 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1986 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

There are two model variations. RX670 and RX670-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX670 is Anti-Glare (AG) treatment and that of the RX670-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce RX670 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX670.

RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX670 and it's not a medical imaging software.

The provided document, K241441, is a 510(k) premarket notification for the RadiForce RX670 and RadiForce RX670-AR medical display monitors. The document demonstrates substantial equivalence to predicate devices (RadiForce RX660, RX660-AR, and RadiForce RS340) for displaying radiological images for review, analysis, and diagnosis, excluding mammography.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "pre-defined criteria" but does not explicitly list the numerical acceptance criteria for each test. Instead, it states that the device "meet[s] the pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device."

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

• Sample Size: The document does not explicitly state the number of RadiForce RX670 units tested. It refers to "the RadiForce RX670" (singular), implying that one or more units of the product were subjected to the specified bench tests.
• Data Provenance: The testing was "bench tests," conducted by the manufacturer, EIZO Corporation, in Japan. The data is thus prospective, originating from the manufacturer's internal testing.

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 involved bench tests of a medical display device, not a study evaluating human interpretation of images or an AI algorithm's diagnostic performance against a ground truth.

4. Adjudication method for the test set:

This information is not applicable as the study involved bench tests of a medical display device, not a study requiring adjudication of expert opinions or 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, an MRMC comparative effectiveness study was not done. This document is for a medical display device, not an AI-powered diagnostic algorithm.

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. This document is for a medical display device, which is hardware, and its associated quality control software (RadiCS). It does not involve a diagnostic algorithm.

7. The type of ground truth used:

This information is not applicable in the traditional sense of diagnostic accuracy studies. For the bench tests, the "ground truth" would be the engineering specifications and established standards (e.g., DICOM GSDF, AAPM TG18 guideline) against which the display's performance characteristics were measured.

8. The sample size for the training set:

This information is not applicable. The device is a display monitor, not an AI algorithm that requires a training set. The RadiCS software mentioned is for quality control and "is not a medical imaging software" and "it's being used unchanged from the predicate software," implying no new algorithm development or training.

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

This information is not applicable for the reasons stated in point 8.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce MX317W is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce MX317W.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W and it's not a medical imaging software.

The provided text describes the RadiForce MX317W, a color LCD monitor for displaying radiological images. It is a Class II device (Product Code: PGY).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and the device's numerical performance against those targets. Instead, it states that the device's characteristics "meet the pre-defined criteria when criteria are set" and that the test results showed "display characteristics equivalent to those of the predicate device, RadiForce MX315W."

However, it lists the types of performance tests conducted, which implies general acceptance criteria for these characteristics:

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

The document describes bench testsperformed on the RadiForce MX317W. It does not mention a "test set" in the context of clinical data, images, or patient cases. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable to this type of device and study. The testing was performed on the physical monitor itself.

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. The ground truth for the performance of a display device is established through technical measurements using specialized equipment and adherence to industry standards/guidelines (e.g., AAPM TG18), rather than expert consensus on medical images.

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

This information is not applicable as there was no clinical test set involving human interpretation of images. The performance was assessed through objective physical measurements.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic software, not for a display device like the RadiForce MX317W. The document explicitly states: "No animal or clinical testing was performed on the RadiForce MX317W."

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

This information is not applicable. The RadiForce MX317W is a display device, not an algorithm or AI system. Its performance is assessed as a standalone hardware unit for displaying images, not as an algorithm's standalone performance.

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

The ground truth for the display characteristics (e.g., MTF, luminance, DICOM GSDF conformance) was established based on technical standards and guidelines, specifically "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022, and the "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)". This involves objective physical measurements against defined technical specifications.

8. The sample size for the training set

This information is not applicable. The RadiForce MX317W is a hardware display device and does not involve machine learning algorithms that require a "training set."

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

This information is not applicable, as there was no training set.

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This product is intended to provide color video displays of images from endoscopic camera systems and other compatible medical imaging systems. This product is a wide-screen, high-definition monitor for real-time use during endoscopic/laparoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

CuratOR EX3242-FD is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 3,840 x 2,160 pixels (4K UHD) with a pixel pitch of 0.185 mm.

Based on the provided text, the device in question, CuratOR EX3242-FD, is a color LCD monitor intended for displaying medical images from endoscopic camera systems and other compatible medical imaging systems. It is not an AI-powered diagnostic device, but rather a display monitor.

Therefore, the typical acceptance criteria and study types requested in your prompt (such as accuracy, sensitivity, specificity, expert ground truth, multi-reader multi-case studies, effect size of AI assistance, etc.) are not applicable to this device.

The study described in the document is a comparison of technological characteristics to a predicate device (Olympus 4K UHD LCD Monitor OEV321UH, K220069) to demonstrate substantial equivalence for regulatory clearance.

Here's a breakdown of the information that is available:

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

The provided text does not list specific "acceptance criteria" in the traditional sense for diagnostic performance, as this is a display device. Instead, it compares the technological characteristics of the "Subject Device" (CuratOR EX3242-FD) to a "Predicate Device" (Olympus 4K UHD LCD Monitor OEV321UH). The "performance" in this context refers to meeting or being comparable to the predicate device's specifications.

The conclusion states: "It was confirmed that the technological characteristics differences from those of the predicate device do not affect the safety or the effectiveness." This serves as the "acceptance criterion" for this type of submission (substantial equivalence for a display device).

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

Not applicable. This is a display device, not a diagnostic algorithm that processes test image sets.

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

Not applicable. Ground truth for diagnostic performance is not relevant for a display monitor's 510(k) submission based on technological equivalence.

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

Not applicable.

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. The device is a monitor, not an AI-assisted diagnostic tool.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce MX217 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX217 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce MX217. RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX217 and it's not a medical imaging software.

The provided text is a 510(k) summary for the EIZO RadiForce MX217 display device. This document focuses on demonstrating substantial equivalence to a predicate device (RadiForce MX216) rather than proving the device meets specific acceptance criteria based on a study with a test set, ground truth, or expert consensus in the way an AI/CADe device would.

The document discusses performance testing of the monitor itself, which involves technical measurements of display characteristics. It does not describe a study involving medical images, human readers, or AI algorithms for diagnostic purposes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training/test set) are not applicable to this document as it pertains to a display device, not a diagnostic AI or image processing software that produces a diagnostic output.

However, I can extract the information related to the device's technical specifications and the bench tests conducted to show its performance regarding those specifications.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not available or not applicable given the nature of the device (a display monitor):

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

The document states:
"The test results showed that the RadiForce MX217 has display characteristics equivalent to those of the predicate device, RadiForce MX216."
And:
"Besides, the display characteristics of the RadiForce MX217 meet the pre-defined criteria when criteria are set."

However, it does not explicitly list the "pre-defined criteria" or "acceptance criteria" in a quantitative table with corresponding performance values for each criterion. It only lists the types of tests performed.

Types of Bench Tests Performed:

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

• Sample Size: Not applicable. This is a display device, not an AI/CADe system. The "test set" would be the device itself undergoing various physical and photometric measurements. The document refers to "bench tests" performed on the RadiForce MX217.
• Data Provenance: Not applicable. The "data" are measurements from the device, not clinical imaging data.

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 clinical images or diagnostic outcomes is not relevant for testing a display monitor's technical performance. The "ground truth" for these tests would be the established technical standards (e.g., TG18 guidelines, DICOM GSDF) that the device is measured against.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not relevant for the technical testing of a display 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 is a display device, not an AI/CADe system. An MRMC study is not relevant.

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

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

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

• The "ground truth" for the performance tests of this display device refers to established industry standards and guidelines for display quality, such as:
  • "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (September 28, 2022)
  • "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)"
  • DICOM GSDF (Grayscale Standard Display Function)

8. The sample size for the training set

• Not applicable. This is a display device, not an AI/machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As there's no training set, there's no ground truth to establish for it.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce RX270 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

There are two model variations. RX270 and RX270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX270 is Anti-Glare (AG) treatment and that of the RX270-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX270 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX270.

RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX270 and it's not a medical imaging software.

This document does not contain information about an AI/ML device or its performance criteria. The device described, RadiForce RX270 and RX270-AR, is a medical grade display monitor. The submission states that the device is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography."

The performance testing section (Section 7) describes bench tests performed on the display monitor to evaluate its characteristics, such as spatial resolution (MTF), pixel defects, artifacts, temporal response, luminance, and conformance to DICOM GSDF. These tests are standard for evaluating medical displays and ensure the monitor can accurately present radiological images.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, a multi-reader multi-case (MRMC) study, or standalone algorithm performance. The document focuses on the technical specifications and performance validation of a display device, not an AI or imaging analysis product.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce MX243W is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,920 x 1,200 pixels (2.3MP) with a pixel pitch of 0.270 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX243W based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce MX243W.

RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX243W and it's not a medical imaging software.

The provided document is a 510(k) summary for the EIZO RadiForce MX243W medical display. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance testing of the display itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies (sample size for test/training set, data provenance, number/qualifications of experts, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the RadiForce MX243W's display characteristics meet "pre-defined criteria when criteria are set" and are "equivalent to those of the predicate device, RadiForce MX242W." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported performance values. It only lists the types of tests performed.

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

This is not applicable as the submission is for a medical display, not an AI/ML device that operates on patient data. The tests were performed on the physical display unit.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert labels on medical images) does not apply to the performance testing of a monitor. The tests performed are objective measurements based on established guidelines.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this submission (a medical display).

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

No, a standalone performance study was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for display performance testing refers to objective physical standards and measurements rather than expert consensus on medical findings. The tests performed are based on guidelines such as the AAPM TG18 guideline and "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The manufacturer performed bench tests on the RadiForce MX243W medical display. These tests were conducted following the instructions in the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and referenced the AAPM Task Group 18 (TG18) guideline for assessment of display performance.

The specific tests performed include:

• Measurement of spatial resolution (Modulation Transfer Function - MTF)
• Evaluation of pixel defects/faults
• Visual check for miscellaneous artifacts on the display screen (as specified in TG18)
• Measurement of temporal response
• Measurement of Luminance
• Verification of conformance to DICOM GSDF (as specified in TG18)
• Measurement of pixel aperture ratio
• Measurement of Color tracking

The document states that the "test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W" and that "the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set."

No animal or clinical testing was performed for this device. The conclusion is that the device is substantially equivalent to its predicate based on its intended use, that technological differences do not affect safety or effectiveness, and that the bench tests demonstrated equivalent display characteristics.

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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce RX370 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing high contrast ratio and the matrix size (or resolution) is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX370 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX370.

The provided text describes a 510(k) submission for the EIZO RadiForce RX370, a medical display monitor. The document confirms that the device is substantially equivalent to a predicate device and outlines performance testing conducted. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's a breakdown of what can be extracted and what information is missing:

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

The document mentions that the RadiForce RX370 meets "pre-defined criteria when criteria are set" for its display characteristics, and that it has "display characteristics equivalent to those of the predicate device, RadiForce RX360." It lists several performance tests conducted, but it does not provide a table with specific numerical acceptance criteria and the corresponding reported device performance values.

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

The document explicitly states: "No animal or clinical testing was performed on the RadiForce RX370." Therefore, there is no "test set" in the context of patient data or clinical images, and thus no sample size or data provenance to report in that sense. The tests mentioned were "bench tests" performed on the device itself.

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

Since no clinical or animal testing was performed, there was no "test set" requiring expert consensus for ground truth.

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

Not applicable, as no clinical or animal testing with a test set was performed.

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. The device is a display monitor, not an AI-powered diagnostic tool. No MRMC study was mentioned or implied.

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 algorithm.

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

Given that the performance testing involved "bench tests" on the display monitor itself, the "ground truth" would be the technical specifications and standards (e.g., DICOM GSDF, TG18 guidelines) against which the monitor's performance (luminance, MTF, pixel defects, etc.) was measured.

8. The sample size for the training set:

Not applicable. The device is a display monitor, not an AI system that requires a training set.

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

Not applicable.

Summary of available information regarding acceptance criteria and study:

The device is a medical display monitor (RadiForce RX370) intended for displaying radiological images.

Acceptance Criteria and Reported Device Performance (Partial based on available info):

Study Information:

• Study Name: Performance Testing (Bench Tests)
• Device Under Test: RadiForce RX370
• Sample Size (Test Set): Not applicable (no clinical or animal testing). The "sample" would be the individual monitor unit(s) subjected to the bench tests.
• Data Provenance: Not applicable (no patient/clinical data).
• Ground Truth Establishment (for Test Set): Technical specifications and guidelines outlined in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and AAPM Task Group 18 (TG18 guideline).
• Number of Experts/Qualifications: Not explicitly stated, but the tests are based on established industry guidelines that would have been developed by experts in the field.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance Study: Not applicable (device is a monitor, not an algorithm).
• Training Set Sample Size: Not applicable.
• Training Set Ground Truth: Not applicable.

In essence, the "study" proving the device meets acceptance criteria was a series of engineering/technical bench tests designed to ensure the display characteristics of the RadiForce RX370 met established standards for medical monitors and were equivalent to its predicate device.

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