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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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JUSHA-C630G/JUSHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the display system with the high resolution (3280×2048), high luminance (1050 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT. In addition, C630G has ambient brightness adaptation inside, 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: - 30" Color TFT LCD Panel - DMX0704AR0/main board/REV:1.1 - JUSHA-C630G LCD Monitor software - Power Adapter - Data Cable. 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, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

Based on the provided FDA 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. JUSHA-C630G LCD Monitor, here's an analysis of the acceptance criteria and study proving they are met:

This document is for a medical display device (LCD monitor), not an AI algorithm for image analysis. Therefore, many of the typical questions for an AI device's performance study (such as sample size for test/training sets, experts for ground truth, MRMC studies, etc.) are not applicable to this type of device. The "study" here primarily refers to bench testing to ensure the monitor meets display performance standards.

The primary method for demonstrating substantial equivalence for this device is bench testing against established industry standards and comparison to a predicate device.

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

Note: The 510(k) summary asserts that the device meets the performance standards, but does not explicitly provide the numerical results of each test. This is common in 510(k) summaries, where the detailed test reports are submitted to the FDA for review, and the summary highlights the conclusion of compliance.

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

• Sample Size: Not applicable in the context of image data for an AI algorithm. This is a hardware device (LCD monitor). The "sample" would be the manufactured unit(s) themselves undergoing physical and electrical bench testing. The document does not specify the number of units tested.
• Data Provenance: Not applicable in the context of patient data. The "data" are measurements taken from the display device itself.

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

• Number of Experts/Qualifications: Not applicable. Ground truth in this context is established by objective measurements based on standards (like AAPM TG18, IEC 60601-1, IEC 60601-1-2) performed by qualified technicians/engineers using calibrated equipment. It does not involve human interpretation of medical images.

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

• Adjudication Method: Not applicable. This refers to the resolution of discrepancies in expert labeling of medical images, which is not relevant for a display performance study.

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: Not applicable. MRMC studies are used to evaluate diagnostic accuracy and reader performance with AI assistance, which is not the purpose of evaluating a diagnostic display.

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

• Standalone Performance: Not applicable. This device is a display monitor, not an AI algorithm. Its performance is inherent to its physical and electronic characteristics.

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

• Type of Ground Truth: The ground truth for this device's performance is based on established industry and international standards for medical displays (e.g., AAPM TG18 guidelines for display quality; IEC 60601-1 for electrical safety; IEC 60601-1-2 for EMC). Compliance with these objective, measurable benchmarks constitutes the "ground truth" for a display device.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI that requires a "training set."

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

• Training Set Ground Truth: Not applicable for the reasons stated above.

Summary for this specific device:

The FDA 510(k) for the JUSHA-C630G LCD Monitor relies on bench testing to confirm compliance with recognized performance and safety standards for medical display devices (e.g., AAPM TG18, IEC 60601-1, IEC 60601-1-2). This assessment ensures the monitor can accurately and safely display medical images for diagnostic purposes. It is explicitly stated that no animal or clinical studies were required to support substantial equivalence for this type of device, as its equivalence is based on technical specifications and adherence to established standards, demonstrating it does not raise new questions of safety or effectiveness compared to its predicate device.

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JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for 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.

JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the display system with the high resolution (4200x2800), high luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA- C1210G has ambient brightness adapt inside. In particular, JUSHA- C1210G 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:

• 31" Color-TFT LCD Panel
• DMF2604AR0/main board/REV1.0
• JUSHA-C1210G LCD Monitor software
• Power Adapter
• Data Cable.

Here's a breakdown of the acceptance criteria and the study information for the JUSHA-C1210G LCD Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding reported device performance values in a direct, comparative format. Instead, it describes various performance evaluations that were conducted and states that the device "meets all performance standards" and "complies with" certain industry standards.

The acceptance criteria are implicitly defined by the standards and performance measurements listed under "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC)". The reported device performance is indicated by the general statement of compliance.

Therefore, the table below is constructed by inferring the acceptance criteria from the tests mentioned and noting the general statement of compliance as the "reported device performance."

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

The document describes "bench testing" of the LCD monitor. For a display device, the "test set" would typically refer to the specific unit(s) of the device being evaluated. However, the document does not specify the sample size (number of units) used for these bench tests.

The data provenance is also not explicitly stated. It's generally inferred that bench testing is conducted by the manufacturer (Nanjing Jusha Display Technology Co., Ltd. in China), but specific country of origin for the test data, or whether it's retrospective or prospective testing, is not detailed. Given it's a premarket submission, the testing would be prospective for the device seeking clearance.

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 and therefore not provided in the document. The device is an LCD monitor, a hardware display system, not an AI algorithm or diagnostic tool that requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is assessed through objective physical and electrical measurements.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are objective technical measurements of a hardware device's performance against established standards, not subjective interpretations 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms in medical image analysis, not for a standalone hardware display monitor. The document explicitly states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence."

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

Yes, a standalone performance evaluation was done, in the sense that the device's performance was assessed purely on its technical specifications and compliance with standards, without direct human interaction as part of the performance measurement itself. This is what "bench testing" and "electrical safety and EMC" evaluations represent for a display monitor. There is no "algorithm" in the context of an AI device, but rather the intrinsic performance of the display hardware.

7. The Type of Ground Truth Used

For a medical display monitor, the "ground truth" for its performance is typically defined by:

• Industry standards and specifications: Such as those from AAPM (American Association of Physicists in Medicine) or DICOM (Digital Imaging and Communications in Medicine) for display characteristics. The document mentions compliance with "TG18 guideline" (likely AAPM TG18 for display quality control) and "DICOM standard LUT."
• International safety and EMC standards: Specifically IEC 60601-1 and IEC 60601-1-2.

These standards and guidelines serve as the objective "ground truth" against which the monitor's physical, photometric, and electrical properties are measured and evaluated for compliance.

8. The Sample Size for the Training Set

This information is not applicable. The device is an LCD monitor, not an AI algorithm that undergoes training.

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

This information is not applicable as the device is not an AI algorithm requiring a training set with ground truth.

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JUSHA-CP610 LCD Monitor, CP610 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 does not support the display of mammography images for diagnosis.

JUSHA-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g 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.
The product is consisted of the following components:

• 13.5" Color TFT LCD Panel
• DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
• JUSHA-CP610 LCD Monitor software
• Power Adapter
• Data Cable.

The software that supports the functions of the CP610 is the same as the software used with the predicate JUSHA C61. The level of concern was determined to be Moderate for the JUSHA-CP610 LCD Monitor.
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, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The provided document is a 510(k) summary for the JUSHA-CP610 LCD Monitor. It describes the device, its intended use, and a comparison to a predicate device (JUSHA-C61 LCD Monitor) to demonstrate substantial equivalence.

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

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in a clearly defined pass/fail format for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and adherence to relevant standards. The "performance" described is in terms of meeting these standards and having comparable or improved technical characteristics.

Here's an attempt to structure the information as requested, drawing from the "Product Comparison" table and "Performance Data" section. Note that "acceptance criteria" for a display device are often encapsulated by adherence to industry standards for medical displays.

Here's the additional information requested:

1. 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 describe a "test set" in the context of clinical data for software performance. The device is a display monitor, and its performance was evaluated through bench testing and adherence to international standards. There is no information about data provenance or sample size for a "test set" of medical images as it primarily relies on the physical and electrical characteristics of the display.

2. 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. The ground truth concept for clinical performance data is not relevant here as the device is a display monitor, not an AI algorithm performing diagnosis. The "truth" for this device lies in its ability to accurately and consistently display images according to technical specifications and standards (e.g., DICOM standard LUT).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   Not applicable, as there is no "test set" or clinical adjudication process described for this display device.

4. 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 monitor, not an AI-powered diagnostic system. No MRMC study was conducted or is relevant for this type of device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a display monitor, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   For a display monitor, the "ground truth" used for evaluation is based on technical specifications, industry standards (e.g., DICOM, TG18), and physical measurements. The performance data section describes measurements against these standards (e.g., luminance, chromaticity, contrast ratio).

7. The sample size for the training set
   Not applicable. The device is a display monitor, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established
   Not applicable, as there is no training set for this device.

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The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 23.8-inch widescreen LCD display panel and employs full WUXGA high-definition (HID) performance. In addition to digital signals, the E240AG accepts analog signals and converts them to digital signals. The E240AG LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.

This document describes the premarket notification (510(k)) for the E240AG LCD Monitor and its variants, which are medical display monitors. The provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of clinical outcomes. Instead, it details the submission for a medical monitor and its substantial equivalence to a predicate device based on technical specifications and safety standards.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not available in this document.

However, I can extract the relevant information pertaining to the device (medical monitor) performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it compares the proposed device's specifications to a predicate device and reports compliance with recognized standards. The "performance data" section details bench testing conducted to ensure the device meets certain display and safety characteristics.

Performance Data and Study:

The study conducted was a bench test to demonstrate compliance with recognized standards.

• Measurement of the luminance non-uniformity characteristics of the display screen.
• Measurement of the chromaticity non-uniformity characteristics of the display screen.
• Measurement of contrast ratio.
• Performance data on luminance stability.
• Electrical safety and electromagnetic compatibility (EMC) testing.

2. Sample size used for the test set and the data provenance: Not applicable. This is a technical performance test of hardware, not a clinical study involving a dataset of patient cases.

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 hardware performance like luminance, contrast, and electrical safety is established through engineering specifications and objective measurements, not expert radiologists reviewing images.

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. This device is a display monitor, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For display characteristics (luminance, contrast, chromaticity, luminance stability), the "ground truth" would be established by the industry standards and specifications the device aims to meet. For electrical safety and EMC, the ground truth is defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards. It's objective, quantitative measurement against engineering standards, not clinical ground truth like pathology or expert consensus.

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.

Conclusion from document: The manufacturer concluded that the E240AG LCD Monitor is substantially equivalent to the predicate device (Sony LMD-2451MT) based on similarities in overall purpose, function, technical characteristics, performance, application, and intended use. The bench testing demonstrated compliance with applicable safety and performance standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that animal or clinical studies were not required to support substantial equivalence.

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JUSHA-M550G/JUSHA-M550/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 designed for breast tomosynthesis applications.

JUSHA-M550G/JUSHA-M550/M550G/M550 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, JUSHA-M550G has ambient brightness adapt inside. In particular, JUSHA-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 - DMX0704AR0/main board/REV1.1 - JUSHA-M550G LCD Monitor software - Power Adapter - Data Cable

The document describes the JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor, intended for displaying and viewing digital images, including standard and multi-frame digital mammography and breast tomosynthesis applications.

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

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format but outlines the performance tests conducted, implying that the device met acceptable standards for these tests. The comparison to the predicate device (BARCO MDMG-5221; K161229) is a key aspect of demonstrating substantial equivalence.

Comparison to Predicate Device (BARCO MDMG-5221):

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

The document states that bench testing was conducted. For device performance testing of this nature (LCD monitor characteristics), the "sample size" typically refers to the number of units tested. However, this specific number is not explicitly mentioned in the provided text.

The data provenance is implied to be from the manufacturer's internal testing facilities (Nanjing Jusha Display Technology Co., Ltd) and is retrospective in the sense that the results were submitted for regulatory review after the tests were completed. There is no information about the country of origin of the data itself in terms of medical images or patient information, as this device is a display monitor and not an AI algorithm processing medical data.

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

This question is not applicable in the context of this device. The JUSHA-M550G/M550 is an LCD monitor for displaying images, not a diagnostic or interpretive AI algorithm. Therefore, there is no "ground truth" to be established by medical experts for its performance, beyond ensuring it accurately and consistently displays existing medical images. The performance is assessed against technical specifications and conformity to standards like TG18.

4. Adjudication method for the test set

Not applicable. As explained above, for an LCD monitor's performance testing, there is no "ground truth" to be adjudicated in the sense of a medical diagnosis. The performance is evaluated based on 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 an LCD display monitor, not an AI-powered diagnostic tool. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this submission.

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

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

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

Not applicable. As explained in point 3, the concept of "ground truth" for medical diagnosis does not apply to the technical performance evaluation of an LCD display monitor. The "ground truth" for the device's technical specifications is established by predefined industry standards and measurements (e.g., DICOM standard, TG18 guideline).

8. The sample size for the training set

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

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

Not applicable. As explained in point 8, there is no training set for this device.

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JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, 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 does not support the display of mammography images for diagnosis.

JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , C350G LCD Monitor , C350 LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (800 cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. JUSHA-C350G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C350G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction and focusview function, 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 - DMX0704AR0/main board/REV1.1 - JUSHA-C350G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The document provided is a 510(k) summary for a medical LCD monitor, the JUSHA-C350G, and does not describe an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

Specifically, the document focuses on demonstrating substantial equivalence of the JUSHA-C350G LCD Monitor to a predicate device (JUSHA-C33C) based on performance specifications and compliance with electrical safety and EMC standards. It explicitly states that "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, JUSHA-C350G, does not require animal or clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information for an AI/ML device, as this document pertains to a medical display monitor and does not involve AI/ML technology or associated performance criteria for such systems.

If you have a document describing an AI/ML medical device, please provide it, and I will do my best to extract the relevant information.

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