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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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CL-S301 is 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.

21.3 inch Color LCD Monitor
1536 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. Luminance and the color mura correction functions will help achieve uniformity on the whole screen.

The provided FDA 510(k) summary is for a medical monitor (3MP Color LCD Monitor CL-S301), not an AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance metrics (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of a display hardware.

However, I can extract the acceptance criteria and performance data related to the physical characteristics of the monitor, as well as general information about its intended use and comparison to a predicate device.

Here's the available information based on the provided text:

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

The document presents performance "test items in the guidance" which serve as acceptance criteria for a medical display monitor. The "test method(s)" column describes how these criteria are verified. The conclusion states that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device." This implicitly means the device met the acceptance criteria for each test.

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

This information is not applicable to a physical display device. The tests are performed on the device itself, not on
a "data set" in the context of an AI algorithm. The device manufacturer is JVCKENWOOD Corporation, located in Japan.

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 is not applicable. The "ground truth" for a monitor's performance is based on physical measurements and adherence to technical standards (e.g., ISO, IDMS, AAPM-TG directives), not expert interpretation of medical images.

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

This is not applicable. Adjudication methods are relevant for evaluating expert performance on diagnostic tasks, not for physical device testing.

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

This is not applicable. An MRMC study is used to evaluate the diagnostic performance of a system (often AI-assisted) with human readers. This document describes a monitor, which is a display hardware, not a diagnostic AI system.

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

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

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

The "ground truth" for the monitor's performance is defined by adherence to established technical standards and measurement protocols (e.g., ISO 13406-2, IDMS 1.03, AAPM-TG18/196, IEC 62563-1).

8. The sample size for the training set

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

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

This is not applicable for the same reason as point 8.

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

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

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

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

Here's why the requested information is not available:

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

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

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

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

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

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

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

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

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

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

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These products are 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.

The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

The provided document describes a 510(k) premarket notification for a medical display monitor, the "12MP Color LCD Monitor (C1216W, C12***)". The primary purpose of this document is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device, the EIZO Corporation's 12MP Color LCD Monitor, RadiForce RX1270 (K200485).

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

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

The document does not explicitly state "acceptance criteria" for performance in a tabular format with corresponding reported device performance. Instead, it details performance testing conducted to demonstrate equivalence to the predicate device. The performance characteristics of the proposed device are compared to the predicate device in several tables (Table 1 Intended Use Comparison, and Table 2 General Comparison, which is spread across pages 7 and 8 but not fully reproduced here with all details).

However, based on the "Performance Testing" section (page 9-10), the implied "acceptance criterion" for each test is that the device should demonstrate characteristics equivalent to those of the predicate device or that any differences do not affect observer performance.

Here's a summary of the performance testing performed, which serves as the basis for demonstrating equivalence:

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

The document describes bench tests that were performed on the device. It does not mention a "test set" consisting of patient data or clinical images. The testing is based on the device itself and its intrinsic technical characteristics. Therefore, there's no information about sample size for a test set in the conventional sense of a clinical or image-based study, nor about data provenance (country of origin, retrospective/prospective). The tests were conducted on the physical devices C1216W and C12***.

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

This information is not applicable as the study described is a bench test of a display monitor, not an interpretative study requiring expert ground truth for medical images.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

An MRMC comparative effectiveness study was not done. This submission is for a medical display monitor and does not involve AI assistance or human reader performance evaluation.

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

This information is not applicable as the device is a display monitor, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" in this context refers to established technical standards and measurement specifications, specifically the AAPM Task Group 18 (TG18 guideline), which outlines procedures for evaluating display performance for medical imaging systems. These standards serve as the reference for evaluating the display's inherent technical characteristics.

8. The sample size for the training set

This information is not applicable as the device is a display monitor and does not involve a "training set" in the context of machine learning or AI.

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

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

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C660G/C810G LCD Monitor is intended to be used in displaying digital images diagnosis of X-ray or MRI.etc.by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the display system with high resolution (3280×2048), high luminance (800 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, C660G has ambient brightness adaptation inside, on top of which C660G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.

The product is consisted of the following components:

• the display with stand
• a graphic card
• agraphic card driver CD
• an AC power cable
• an external power supply
• a Type-C cable
• Three DP cables
• a USB cable

JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.

The product is consisted of the following components:

• the display with stand
• a graphic card
• agraphic card driver CD
• an AC power cable
• an external power supply
• a DVI cable
• two Mini DP switch to DP cable
• a USB cable

The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The provided document describes the FDA 510(k) premarket notification for the JUSHA-C810G/C810G LCD Monitor and JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor. These are medical image display systems.

The acceptance criteria for this device are based on its performance specifications and compliance with recognized standards, demonstrating substantial equivalence to a legally marketed predicate device (C630G, K222121).

Here's a breakdown of the requested information:

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

The document provides a comparison table against a predicate device, which indicates the performance criteria and how the proposed devices (C660G and C810G) compare. The acceptance criteria are implicitly those of the predicate device and relevant industry standards.

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 states that no clinical studies were required to support substantial equivalence for this device (medical image display monitors). The testing performed was "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC) testing" on the physical devices themselves. Therefore, there is no "test set" in the context of clinical data, no sample size of patients/cases, and no data provenance from patients/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)

Not applicable. As noted above, no clinical studies with expert-established ground truth were performed or required for this device type. The performance evaluation relied on engineering bench testing and compliance with recognized standards.

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

Not applicable. No clinical test set requiring expert adjudication was used.

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

Not applicable. This device is a display monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was conducted.

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

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

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

Not applicable. The "ground truth" for evaluating this device's performance is objective technical specifications and compliance with international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and display performance (TG18 guideline).

8. The sample size for the training set

Not applicable. This device is a display monitor and does not involve machine learning algorithms requiring a training set.

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

Not applicable. As there is no training set.

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C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

C350G LCD Monitor is the display system with the high resolution (2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C350G has ambient brightness adapting, real-time DICOM automatic calibration and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.

The product is consisted of the following components:

• 21.3" Color TFT LCD Panel
• DMX3304AR2/main board
• C350G LCD Monitor software
• a graphic card
• a graphic card driver CD
• a CGA software CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

M550G LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, M550G has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components:

• 21.3" Mono-TFT LCD Panel
• DMX3304AR2/main board
• M550G LCD Monitor software
• a graphic card
• a graphic card driver CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

The provided text is a 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. C350/C350G LCD Monitor and M550/M550G LCD Monitor. This document states that no clinical studies were required or conducted to support substantial equivalence for these medical display monitors. Therefore, there is no information available in the provided text regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, or clinical performance compared to human readers.

The performance data described are related to bench testing and electrical safety/EMC, which are non-clinical evaluations of the device's technical specifications.

Here's an analysis of what is provided:

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

The document provides a comparison of specifications between the proposed devices (C350G and M550G LCD Monitors) and their respective predicate devices (C270G and BARCO MDMG-5221 LCD Monitors). While these are technical specifications, they implicitly represent the performance and quality standards the proposed devices must meet or exceed to be considered substantially equivalent. There isn't a formal "acceptance criteria" table in the sense of a clinical study, but rather a comparison of technical attributes.

Implicit Acceptance Criteria (Technical Specifications) and Reported Device Performance:

• For C350G LCD Monitor (compared to predicate C270G LCD Monitor):

• For M550G LCD Monitor (compared to predicate BARCO MDMG-5221 LCD Monitor):

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. The submission states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." Therefore, no clinical test set was used. The "test set" in this context refers to the specific physical units of the monitors that underwent bench testing and electrical safety/EMC testing.

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

• Not applicable. As no clinical studies were performed, no ground truth established by experts was required for the purpose of this 510(k) submission.

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

• Not applicable. No clinical test set.

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 MRMC study was done. This device is a display monitor, not an AI-powered diagnostic tool. The submission explicitly states "The software doesn't include any functions of image manipulation."

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

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

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

• Not applicable. No clinical ground truth was established or used for the purpose of this submission. The "ground truth" for the bench testing would be the physical and electrical specifications of the monitors, measured against industry standards (e.g., TG18 guideline for display characteristics) and engineering requirements.

8. The sample size for the training set

• Not applicable. No machine learning model or "training set" in that sense was used or discussed in this 510(k) summary.

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

• Not applicable. As above, no training set for an algorithm was used.

Summary of Study:

The "study" cited in this 510(k) summary to prove the device meets acceptance criteria consists of non-clinical bench testing and electrical safety and electromagnetic compatibility (EMC) testing. This is typical for medical devices that are primarily hardware components and do not have algorithmic diagnostic or therapeutic functions.

• Bench Testing: Evaluated display characteristics such as luminance response, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, and luminance stability. These tests were conducted against general performance standards and guidelines (e.g., TGI18 guideline).
• Electrical safety and EMC testing: The devices demonstrated compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards.

The conclusion is that the proposed monitors are "substantially equivalent" to predicate devices based on these non-clinical tests, implying they are as safe and effective and perform as intended.

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C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

• 21.3" Color-TFT LCD Panel
• DMX0704AR1/Main Board/REV: 1.2
• C510G LCD Monitor software
• Power Adapter
• Data Cable.

The provided text describes the regulatory clearance for the Nanjing Jusha Display Technology Co., Ltd's C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor. This device is a medical display intended for viewing and diagnosing digital images, including mammography and breast tomosynthesis applications.

Crucially, the document states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, C510G, does not require animal or clinical studies to support substantial equivalence."

Therefore, the following points regarding acceptance criteria and study proving performance are not applicable as they relate to clinical studies or studies using ground truth established by experts/pathology/outcomes data. The device's clearance was based on demonstrating substantial equivalence to a predicate device (JUSHA-M550G; K190848) through non-clinical bench testing and adherence to relevant standards.

Based on the provided document, here's what can be extracted and what cannot:

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

The document describes performance measurements that were conducted as part of bench testing, but it does not specify explicit "acceptance criteria" values against which these measurements were compared. Instead, it states that the device "meets all performance standards" and "complies with" certain IEC standards. The comparison table shows the specifications of the proposed device against the predicate.

The following information cannot be provided from the given document because the device did not require clinical studies for its substantial equivalence determination:

2. Sample size used for the test set and the data provenance: Not applicable (no clinical test set).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no clinical test set requiring ground truth).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no clinical test set requiring adjudication).
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 (no AI component, no MRMC study).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is a display monitor, not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical study or ground truth required).
8. The sample size for the training set: Not applicable (no training set for a display monitor).
9. How the ground truth for the training set was established: Not applicable (no training set).

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CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

CP620G/CP620 LCD Monitor is the display system with the high resolution (30002000), high luminance (500 cd/m2), and 4398 billion colors, built-in DICOM standard LUT. Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. ) The product is consisted of the following components: - 13.5" Color-TFT LCD Panel - DMS3400AR0/6 layers/214150mm/1.0mm/REV:1.0 - CP620G LCD Monitor software - Power Adapter - Data Cable. In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The information provided describes the Nanjing Jusha Display Technology Co., Ltd. CP620G LCD Monitor / CP620 LCD Monitor. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of measurable thresholds for diagnostic accuracy (e.g., sensitivity, specificity for an AI algorithm). Instead, the performance data presented focuses on the technical specifications of the display and compliance with established electrical safety and electromagnetic compatibility (EMC) standards. The "predicate device" is used as the benchmark for substantial equivalence.

Discussion of Differences:

• Recommended Luminance: The proposed device has a higher recommended luminance (500cd/m2) than the predicate (300cd/m2), which is considered an improvement ("CP620G is better than CP610").
• Video Signal Input: The proposed device has different input ports (Type-C x2, HDMI x1 vs. Type-C x1, Mini DP x1). This difference is stated to "only shows that they have different input, has nothing to do with the display function."
• Power Consumption/Save Mode: The proposed device has a higher power consumption (20W vs. 15W). This is attributed to "components used in the LCD Monitor" and is stated to have "nothing to do with the display function."
• Dimensions w/o stand: Slight differences are noted (312.3mmx220mmx11.5mm vs. 323mmx225x11.5mm), explained as "Different housing design due to the different glass size."
• New Features: The proposed device includes new features: Bidirectional power supply function, dual-screen display function, gravity sensing function, adaptive environment brightness function, and screen touch function. These are all described as making the product "more convenient" and "has nothing to do with the display function" (except for dual-screen display, which allows two independent 3MP windows side-by-side).

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

The document describes bench testing for the CP620/CP620G. There is no mention of a "test set" in the context of clinical images or patient data. The testing pertains to the physical and electrical performance of the display monitor itself. Therefore, concepts like sample size and data provenance (country, retrospective/prospective) are not applicable in the way they would be for an AI diagnostic algorithm. The tests conducted include:

• Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
• Measurement of the luminance non-uniformity characteristics of the display screen
• Measurement of the chromaticity non-uniformity characteristics of the display screen
• Measurement of small-spot contrast ratio
• Measurement of temporal response
• Performance data on luminance stability

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 an LCD monitor for displaying medical images, not an AI algorithm that provides diagnostic interpretations requiring expert ground truth setting for a dataset. The "ground truth" for this device relates to its physical performance characteristics meeting technical specifications, which are verified through various physical and electrical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

No MRMC comparative effectiveness study was done. This device is an LCD monitor, not an AI diagnostic tool.

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

This information is not applicable. This device is not an algorithm.

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

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

• Technical Specifications: Measured physical and electrical properties of the display (luminance, contrast, resolution, viewing angle, color, etc.) matching or exceeding the predicate device's specifications.
• Compliance with Standards: Adherence to recognized medical device safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.

8. The sample size for the training set

This information is not applicable. 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 for the reasons stated above.

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