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CL-S500 and MS-S500 are intended to be used in displaying 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.

CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted

MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.

The acceptance criteria for the JVC Kenwood CL-S500 (color) and MS-S500 (monochrome) LCD monitors, intended for medical image display in digital mammography PACS, digital breast tomosynthesis, and FFDM, are based on a comparison to a predicate device (CCL550i2/ K160326) and adherence to established display quality standards (AAPM-TG18 and ISO13406-2).

The study primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and performance of the new devices to the predicate device and relevant industry standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" as a separate, quantitative target for each metric beyond direct comparison to the predicate device or a reference to a standard (e.g., AAPM-TG18 passing criteria). However, the "Explanation of Differences" column in the substantial equivalence comparison tables implicitly suggests the acceptance criteria where the new device must be equivalent to or better than the predicate, or meet the requirements of the specified standard.

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CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

2MP Color LCD Monitor CL-R211. Resolution: 1600 x 1200 (landscape), 1200 x 1600 (portrait). DVI (digital interface) and DisplayPort (digital interface).

This document describes the JVC Kenwood 2MP Color LCD Monitor CL-R211 (K182539), a medical display intended for diagnostic viewing of medical images. The acceptance criteria and supporting study details are as follows:

1. Acceptance Criteria and Reported Device Performance:

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

The provided document does not contain information regarding a specific "test set" and its sample size or data provenance in the context of clinical image data. The performance criteria relate to the technical specifications and physical characteristics of the monitor itself. The studies mentioned are standard performance tests for display monitors, not clinical trials with patient data.

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 device is a display monitor, and its performance is evaluated against technical specifications and established standards (like AAPM-TG18 and ISO13406-2), not against clinical ground truth established by medical experts for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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. The device is a display monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to its intended use.

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

This information is not applicable for the reasons stated above. The device is a display monitor, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on established technical standards and measurements. For example, for luminance response, the ground truth is the specified deviation from a target based on AAPM-TG18 guidelines; for pixel defects, it's the ISO13406-2 standard. For artifacts, it's a "visible check" for the absence of defects.

8. The sample size for the training set:

This information is not applicable. The device is a hardware product (display monitor), not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

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CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait)
DVI (digital interface) and DisplayPort (digital interface)

The provided text describes the acceptance criteria and performance of medical LCD monitors (CL-S200 and CL-S300) for displaying and viewing medical images. It's a 510(k) summary for these devices, asserting their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and whether the document describes a study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Technical Specification" section that lists acceptance criteria (referred to as [SPEC]) and then compares the new devices (CL-S200xxxxx, CL-S300xxxxx) against a predicate device (CCL214/[K161895](https://510k.innolitics.com/search/K161895)) in a "Substantial Equivalence Comparison" table. This comparison implicitly shows the reported device performance.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed results from a new comprehensive performance study. The "performance" listed (e.g., Maximum Luminance, Contrast Ratio) are device specifications and comparisons to the predicate, not explicitly "reported device performance" from a dedicated study proving they meet each [SPEC] criterion with actual measured values. The assertion that they "share the same technical characteristics" is the primary argument for meeting the criteria.

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

This document describes medical display monitors, not an AI or diagnostic algorithm, so there is no "test set" of images or patient data in the typical sense. The performance criteria relate to the physical and optical properties of the display.

• Sample Size: Not applicable in the context of image data. The "sample size" would refer to the number of monitors tested. The document does not specify the number of monitors tested for these technical specifications.
• Data Provenance: Not applicable to image data. The technical specifications are inherent to the monitor design and manufacturing.

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

Not applicable. Ground truth for display monitor performance is established by objective physical measurements (e.g., luminance meters, colorimeters, spectroradiometers) according to specified standards like AAPM-TG18 and ISO13406-2, not by expert consensus on medical images.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of a test set requiring adjudication for these medical 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

Not applicable. This document is about medical display monitors, not an AI or diagnostic algorithm that assists human readers.

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

Not applicable. This document is about medical display monitors, which are passive display devices, not standalone algorithms.

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

The ground truth for the "acceptance criteria" (technical specifications) of these monitors is based on objective physical measurements using specialized equipment and established industry standards (e.g., AAPM-TG18, ISO13406-2) for display performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

In Summary:

The provided document details a 510(k) submission for medical display monitors. Its primary goal is to demonstrate "substantial equivalence" to existing legally marketed predicate devices, not to present a comprehensive, independent study proving performance against each specific acceptance criterion with detailed, quantitative results from a large test set (which would be typical for an AI algorithm). The implicit proof of meeting acceptance criteria comes from the assertion that the new devices "share the same technical characteristics, application, and intended use" as the predicate device, and by listing their general specifications. The "acceptance criteria" are technical specifications related to display quality, and "proof" comes from internal testing and compliance with display standards, rather than clinical studies with patient data and expert ground truth.

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2MP Color LCD Monitor CCL214 (CL21214) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).

This document is a 510(k) Summary for the JVC KENWOOD 2MP Color LCD Monitor CCL214 (CL21214). It does not describe a study involving an AI algorithm or analysis of medical images for diagnostic purposes by AI. Instead, it describes a medical display monitor. Therefore, many of the requested fields are not applicable.

Here's an analysis of the provided text based on your request, focusing on the device and its performance criteria:

Device: 2MP Color LCD Monitor CCL214 (CL21214)

Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Predicate Device: 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) (K151134)

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

Study to prove device meets acceptance criteria:

The document states: "JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance."

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

• Sample Size: Not explicitly stated. The testing would involve specific units of the CCL214 monitor. It's not a study on medical images but on the monitor itself.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed by JVC KENWOOD Corporation to verify the monitor's performance against its specifications and international standards.

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

• Not applicable. This is a hardware specification and performance verification, not a clinical study involving experts determining ground truth on medical images. The "ground truth" here is adherence to technical specifications and international standards (e.g., AAPM-TG18, ISO13406-2, safety standards).

4. Adjudication method for the test set:

• Not applicable. This is a hardware verification, not a clinical study requiring adjudication of expert 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. This is a medical display device, not an AI-assisted diagnostic tool.

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

• No. This is a medical display device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is objective technical specifications and adherence to international standards (e.g., luminance uniformity

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5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis

MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

Here's a breakdown of the acceptance criteria and study information for the JVC Kenwood medical monitors, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the JVC KENWOOD monitors (MS55i2 and CCL550i2) primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX540) rather than presenting specific, quantitative acceptance criteria and results. The "acceptance criteria" can be inferred as matching or being equivalent to the key performance specifications of the predicate device, especially those related to image quality and functionality for diagnostic medical imaging.

Explanation of Differences and Performance Justification:

• Grayscale Tones: While the palette size for grayscale tones differs, the document states, "But our monitors pass the exams in AAPM-TG18 4.3 'Luminance Response'. Our monitors are equivalent to the predicated device." This indicates that despite the numerical difference in palette size, the devices meet the relevant image quality standards for grayscale reproduction.
• Non-Uniformity Compensation: The JVC KENWOOD system is considered "equivalent to the predicated device's one" in making visual performance "much better in the point of luminance (monochrome and color version) and chromaticity."
• Maximum Luminance (CCL550i2): The color monitor has a lower maximum luminance, but the document clarifies, "However DICOM Calibrated luminance is same as the predicated device. Then actual performance for diagnosis is the same." This is a crucial point, as the calibrated luminance is what's critical for diagnostic viewing.
• Contrast Ratio (CCL550i2): The color model's contrast ratio is higher, which is generally a positive difference.

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

This document does not contain information about a "test set" in the context of clinical images or patient data. The evaluation is focused on the technical performance specifications of the monitors themselves. Therefore, sample sizes for test sets in this sense are not applicable.

• Data Provenance: The data presented is from the manufacturer's (JVC KENWOOD Corporation) testing and comparison against the specifications of the predicate device. The company is based in Japan. This is more akin to bench testing of hardware specifications rather than a clinical study with patient data.

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

Not applicable. This is a technical comparison of monitor specifications, not an evaluation of diagnostic accuracy based on expert interpretation of images. The "ground truth" here is the adherence to technical standards and performance specifications, likely established through engineering measurements and adherence to industry standards like AAPM-TG18.

4. Adjudication Method for the Test Set

Not applicable, as no human reader studies or clinical test sets requiring adjudication are described.

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 510(k) summary is for medical display monitors and does not involve AI or reader studies.

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

Not applicable. This 510(k) summary is for medical display monitors and does not involve algorithms or AI performance.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is primarily technical specifications and performance measurements against established industry standards (e.g., DICOM, AAPM-TG18) and direct comparison with a legally marketed predicate device. The goal is to demonstrate that the new devices perform equivalently or better in terms of visual characteristics critical for medical image diagnosis.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being developed or trained described in this document.

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

Not applicable, as there is no training set mentioned in this document.

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21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).

The provided document is a 510(k) premarket notification for a medical display monitor (JVC KENWOOD Corporation's 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)). This document details the device's technical specifications and compares it to a predicate device to establish substantial equivalence.

It's important to note that this document describes a display monitor, not an AI-powered diagnostic device or an algorithm that processes medical images. Therefore, many of the requested criteria (e.g., sample size, expert ground truth, MRMC studies, standalone performance) are not applicable or relevant to this type of device.

However, I can extract information related to its technical performance criteria and the justification for its equivalence.

Here's an analysis based on the provided text, focusing on the acceptance criteria for a medical display monitor, recognizing that it's not an AI/algorithm-based device:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not applicable. This is a medical display monitor, and the "test set" refers to the individual unit or a small batch of units tested for compliance with performance specifications. It's not testing images or patient data.
• Data Provenance: The testing appears to be internal by the manufacturer (JVC KENWOOD Corporation) and verified by third-party certifiers for safety and EMC standards. The origin of the actual "data" (e.g., luminance measurements) would be from the physical monitor itself during testing procedures.

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 a monitor's performance is established by objective physical measurements against established industry standards (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF). While trained engineers or technicians perform these tests, there isn't a concept of "expert ground truth" in the way it applies to diagnostic algorithms interpreting medical images.

4. Adjudication method for the test set:

• Not applicable. Performance is based on direct measurement against predefined numerical specifications and visual inspection against criteria, not on expert 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:

• Not applicable. This is a display monitor, not an AI-powered diagnostic tool. MRMC studies are used to evaluate diagnostic imaging systems or AI algorithms, not passive display devices.

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

• Not applicable. The device itself is a "standalone" display monitor, but it is not an algorithm, and it has no "human-in-the-loop" component in the sense of AI assistance for diagnosis. Its performance is measured as a standalone piece of hardware.

7. The type of ground truth used:

• The "ground truth" for this device's performance is defined by established industry standards and specifications, such as:
  • AAPM-TG18 (American Association of Physicists in Medicine Task Group 18) for display quality control.
  • ISO13406-2 for pixel defects.
  • DICOM GSDF (Grayscale Standard Display Function) for consistent grayscale reproduction.
  • IEC 60601-1 for medical electrical equipment safety.
  • FCC, MDD/CE, VCCI-B, ICES-003 for electromagnetic compatibility and other regulatory compliance.
• Performance is confirmed through direct physical measurements of the monitor's characteristics (luminance, chromaticity, pixel defects) and visual inspections as per these standards.

8. The sample size for the training set:

• Not applicable. This device does not use an "algorithm" derived from a training set. It's a hardware display whose performance is engineered and then verified.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles and medical display standards.

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21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

The provided text describes the JVC KENWOOD Corporation's 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2 (CL21550) and its substantial equivalence to a predicate device. This document is a 510(k) premarket notification to the FDA. It does not describe a study involving human readers or AI, but rather the technical specifications and testing of a medical display monitor.

Therefore, many of the requested items related to clinical studies, human experts, and AI effectiveness are not applicable to the provided document. The information available focuses on engineering specifications and direct performance measurements of the display device.

Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).

The provided document describes the 510(k) premarket notification for the JVC KENWOOD CORPORATION's 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205). The document primarily focuses on establishing substantial equivalence to a predicate device (ME201L, K021738) rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

However, based on the Technical Specification and Substantial Equivalence Comparison sections, we can infer some performance criteria and how the device (ME205) is claimed to meet them, primarily by comparison to its predecessor and adherence to display standards.

Here's an analysis based on the provided text, specifically addressing the requested information:

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

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

The document does not specify a clinical "test set" sample size or data provenance in the context of a study for diagnostic accuracy. The testing mentioned appears to be related to technical performance characteristics of the monitor itself (e.g., luminance, chromaticity, artifacts) rather than a diagnostic performance study involving medical images and human readers. The "Technical Data" mentioned for comparison with the predicate device is not provided, and its methodology (e.g., sample size of images or tests) is not described.

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

This information is not applicable/not provided. The document describes a medical monitor, not an AI or diagnostic device that would require expert-established ground truth for a test set. The "visible check" for artifacts would likely involve internal quality control personnel rather than external medical experts validating ground truth in a diagnostic sense.

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

This information is not applicable/not provided. No diagnostic "test set" and thus no adjudication method for ground truth is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The device is a medical monitor, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. The ME205 (ML20205) is an LCD monitor for displaying medical images, not an algorithm.

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

This information is not applicable/not provided. The document details the technical specifications and substantial equivalence of a display monitor. Ground truth, in the context of clinical diagnostic accuracy, is not relevant to this type of device submission. The "ground truth" here would be the physical measurements of the monitor's performance characteristics against industry standards (e.g., AAPM-TG18, ISO13406-2) and its own specifications.

8. The sample size for the training set

This information is not applicable/not provided. The device is a monitor, not an AI algorithm that requires a training set.

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

This information is not applicable/not provided. As above, there is no training set for this device.

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21.5 inch (54.5 cm) Color 2M pixel LCD Monitor CCL220 (CL2220) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitor whose display resolution is 1920 x 1080 (landscape), 1080 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.

This document describes a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CCL220 (CL2220). As such, the study described focuses on demonstrating substantial equivalence to a predicate device, rather than on proving performance against clinical endpoints using a traditional clinical trial design with patient data.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Technical Specification" as desired criteria (implicitly, acceptance criteria based on industry standards and performance of the predicate device). The performance is largely reported as "Refer to actual data" or a statement of meeting the specification.

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

• Sample Size for Test Set: Not explicitly stated as a number of monitors tested. The document refers to testing "the CCL220 (CL2220)" in general, implying at least one unit of the device was subjected to these tests.
• Data Provenance: The tests were performed by JVC KENWOOD Corporation as part of their validation process. The "Technical Data" mentioned in section {7} would likely contain the raw data for these tests. The country of origin of the device manufacturer is Japan. The testing is prospective for the purposes of this 510(k) submission, as it was conducted to demonstrate the device's performance.

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

• Number of Experts: Not applicable in the traditional sense of medical image interpretation. The "ground truth" for these technical specifications is defined by industry standards (e.g., AAPM-TG18, ISO13406-2) and the technical capabilities of the device itself.
• Qualifications of Experts: The validation was performed by JVC KENWOOD Corporation's engineering and quality assurance teams. While specific qualifications are not listed, it's implied they have the technical expertise to perform these measurements and ensure compliance with the stated standards.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The tests involve objective measurements against predefined technical specifications.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI-powered diagnostic tool. The document compares the new device (CCL220) to a predicate device (CCL208) on technical specifications, not on clinical effectiveness with human readers.

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

• Standalone Performance: Not applicable. This is a medical display device, not an algorithm. Its "performance" is based on its ability to accurately and consistently display images according to technical standards.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for these technical tests is primarily defined by:
  • Industry Standards: Such as AAPM-TG18 (for luminance uniformity, chromaticity) and ISO13406-2 (for pixel defects).
  • Manufacturer Specifications: The inherent design and expected performance characteristics of the display.
  • Objective Measurements: Using calibrated equipment to measure luminosity, chromaticity, etc.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. As this device is a hardware display monitor, there is no "training set" in the context of machine learning or AI models. The development and calibration would involve engineering processes and manufacturing tolerances.

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

• Ground Truth for Training Set: Not applicable. No training set is used for this type of device. The monitor is designed and manufactured to meet specific technical performance benchmarks.

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24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.

This document is a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CORPORATION's 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244). The information provided focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance or AI-related metrics. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly frame these as "acceptance criteria" and "reported device performance" in a structured table for clinical decision-making metrics. Instead, it lists technical specifications and performance characteristics tested for the device. The "SPEC" column below is derived from the "Technical Specification" section on page 6, and "Reported Device Performance" is inferred from statements like "Refer to actual data" or comparisons to the predicate.

• Maximum Luminance: Both devices have 300 cd/m². The proposed device's DICOM calibrated luminance is 200 cd/m² (higher than predicate's 120 cd/m²).
• Backlight: LED backlight used, which "lasts longer than the conventional CCFL's" and "consumes less power and deteriorates more slowly." No adverse effects on image quality from LED backlight recognized. |
  | Safety and EMC Standards | The device was "validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." Specific standards listed for CCL244: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B), CCC. |

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

This document describes a medical display monitor, not an AI or diagnostic algorithm. Performance evaluation for a monitor primarily involves testing the physical display unit(s) against technical specifications. Therefore, the concept of a "test set" and "data provenance" as typically used for AI or diagnostic studies (e.g., patient cases, retrospective/prospective data) does not apply here. The tests would be performed on the manufactured device models.

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

Again, for a medical display monitor, the "ground truth" is typically objective physical measurements and adherence to technical standards. There isn't a "ground truth" established by medical experts in the context of clinical interpretation for this device. Calibration against standards like AAPM-TG18 would be performed using specialized equipment and trained technicians, not radiologists establishing clinical ground truth.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human interpretation of medical images where adjudication methods like "2+1" or "3+1" would be used. Device performance is determined by objective technical 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:

Not applicable. This device is a display monitor, not an AI-powered diagnostic tool. No MRMC study or AI-assistance evaluation was conducted or is relevant for this product.

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

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

7. The type of ground truth used:

The "ground truth" for this device's performance relies on objective technical specifications and internationally recognized standards. For example:

• Luminance uniformity, chromaticity, power-on luminance drift: Measured against quantitative specifications derived from standards like AAPM-TG18.
• Pixel defects: Assessed against ISO13406-2 standard for LCD pixel defects.
• Artifacts: Assessed by visual inspection against qualitative criteria of "no flicker, ringing, ghosting, image sticking."
• Safety and EMC: Assessed by compliance with relevant international standards (e.g., IEC60601-1, ANSI/AAMI ES60601-1, FCC Class B).

8. The sample size for the training set:

Not applicable. This device is a hardware display monitor and does not involve AI or machine learning models that require a "training set."

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

Not applicable for the reason stated in point 8.

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