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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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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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R190/R191 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.

R190/R191 LCD Monitor is the display system with the resolution (1280*1024), high luminance (800cd/m2), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time.

The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel

• M150M/P38 motherboard/FR-4
• R190/R191 LCD Monitor software
• Power cable
• Data Cable.

The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards.

Here's a breakdown of the acceptance criteria and study information for the Nanjing Jusha Display Technology Co., Ltd. R190/R191 LCD Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the R190/R191 LCD Monitor primarily focuses on demonstrating substantial equivalence to a predicate device (CHILIN MDM 1900-1NR LCD Monitor) through technical specifications and adherence to safety and EMC standards. As such, the "acceptance criteria" are largely defined by these comparative specifications and compliance with standards, rather than specific performance metrics directly measured against a predefined threshold in clinical studies for this particular device.

However, based on the provided text, we can infer some "acceptance criteria" and the reported performance as demonstrated through bench testing and comparison to the predicate.

The study that "proves the device meets the acceptance criteria" is the non-clinical bench testing and the comparison to the predicate device as outlined. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and comparisons demonstrate substantial equivalence and thus meet the necessary criteria for safe and effective use.

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

• Sample Size for the Test Set: Not applicable. This submission relies on bench testing of the device itself and comparison to a predicate device's established performance, rather than a test set of patient cases.
• Data Provenance: Not applicable for a patient data test set. The data provenance for the technical specifications is from the manufacturer's own testing and specifications for both the proposed device and the predicate device (as reported in K061303).

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 with ground truth established by experts was used for this submission. The device is a display monitor, and its performance is evaluated based on technical specifications and adherence to standards, not its ability to interpret medical images.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring 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

• No. An MRMC study was not done. This device is a medical display monitor and does not involve AI assistance for human readers.

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

• No. This device is a display monitor and does not involve an algorithm with standalone performance.

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

• Not applicable in the context of clinical images. The "ground truth" for this device's performance is based on engineering measurements and compliance with established technical international standards for medical displays (e.g., luminance, contrast, resolution, DICOM conformance, safety standards).

8. The Sample Size for the Training Set

• Not applicable. The device is a medical display monitor and does not employ machine learning or AI that would require 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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JUSHA-C620G LCD/JUSHA-C620/C620G/C620 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-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is the display system with the high resolution (3280*2048), high luminance (500 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C620G 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-C620G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction, focusview and text mode 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:

• 30" Color TFT LCD Panel
• C44&C62 Mother board/FR-6/V1.2
• JUSHA-C620G 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:
  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 text is a 510(k) summary for the JUSHA-C620G LCD Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. For such devices, the focus is on non-clinical testing and comparison to a predicate, rather than extensive clinical studies or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment (which are typical for AI/ML medical devices) is not applicable to this specific submission. This device is a medical display monitor, not an AI diagnostic algorithm.

Specifically, the document states:

• "Summary of Clinical Tests: The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." (Page 4, under "Determination of Substantial Equivalence")

This indicates that the manufacturer did not conduct a clinical study to prove the device's performance against specific acceptance criteria in a real-world clinical setting, as would be expected for an AI software. Instead, substantial equivalence was demonstrated through non-clinical tests (meeting safety and performance standards like IEC 60601-1 and IEC 60601-1-2) and a comparison table of characteristics with the predicate device (JUSHA-C61; K141679).

Therefore, I cannot provide the requested details because they are not part of the information required or presented in this 510(k) submission for a medical display monitor.

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JUSHA-C270G/JUSHA-C270/C270G/C270 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C270G 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 - DMX0302CR0/main board/V1.2 - JUSHA-C270G LCD Monitor software - Power Adapter - Data Cable.

The provided document is a 510(k) summary for the JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (JUSHA-C23C, K151861). The document focuses on demonstrating that the new device is as safe and effective as the predicate device through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document defines "acceptance criteria" through compliance with recognized standards and a comparison to a predicate device. The reported performance is based on bench testing.

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

• Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical device being tested against established (non-clinical) performance criteria and standards, rather than a dataset of medical images.
• Data Provenance: Not applicable for a device performance test. The tests were performed on the device itself.

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

• Not applicable. This is a medical display monitor, and its performance evaluation relates to technical specifications and compliance with standards, not diagnostic accuracy based on expert interpretation of images. No ground truth in the sense of medical diagnoses was established for this submission.

4. Adjudication method for the test set:

• Not applicable. As noted above, this submission is for a medical display monitor and does not involve adjudication of diagnostic interpretations.

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

• No MRMC comparative effectiveness study was done. This device is a display monitor, not an AI-powered diagnostic tool. Clinical studies were explicitly stated as not required to support substantial equivalence.

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. Performance tests measured the monitor's technical specifications.

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

• Not applicable. The "ground truth" for this device's performance is established by compliance with international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, TGI18 guideline) and comparison to the technical specifications of a predicate device.

8. The sample size for the training set:

• Not applicable. This device is a display monitor, not an algorithm that requires a training set.

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

• Not applicable. As this is not an algorithm requiring a training set, no ground truth for a training set was established.

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JUSHA-M260G/JUSHA-M260/M260G/M260 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-M260G/JUSHA-M260/M260G/M260 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM standard LUT. In particular, JUSHA-M260G has real-time DICOM automatic calibration 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
• DMX0302CR0/main board/V1.2
• JUSHA-M260G LCD Monitor software
• Power Adapter
• Data Cable.

The provided text describes a 510(k) submission for the JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor. This device is a diagnostic display, not an AI/ML algorithm. Therefore, the questions related to AI/ML specific acceptance criteria, such as "effect size of human readers improve with AI vs without AI assistance," "standalone performance," "ground truth establishment for training set," and "adjudication method for the test set" are not applicable.

The acceptance criteria for this type of device are based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical bench testing for display performance, electrical safety, and electromagnetic compatibility.

Here's a breakdown based on the provided information:

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

Since this is a display monitor, the "acceptance criteria" are generally that the proposed device performs at least as well as, or is substantially equivalent to, the predicate device in key display parameters and safety. Performance is demonstrated through bench testing against established industry standards.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For a monitor, performance is tested on the device itself against specifications and standards. This is typically done on a single or small number of manufactured units to demonstrate general compliance.
• Data Provenance: Not applicable. The "data" here refers to the physical performance characteristics of the monitor, not a dataset of patient images.

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

• Not applicable. This device is a monitor, not an AI/ML algorithm that generates diagnostic outputs requiring expert ground truth for interpretation. Its performance is measured objectively against technical specifications and established standards (e.g., TG18 guideline).

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

• Not applicable. Adjudication methods are used to establish a consensus ground truth in studies involving human interpretation or AI outputs, which is not relevant for a display monitor's performance evaluation.

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

• Not applicable. This is a display monitor, not an AI-powered diagnostic tool. No MRMC study was conducted or required, as stated in the document ("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

• 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 a display monitor is its adherence to universally accepted technical standards for image display (e.g., DICOM, luminance, resolution, contrast). These are measurable objective properties, not clinical "truths."

8. The sample size for the training set

• Not applicable. This is a hardware device (LCD monitor), not a machine learning model. There is no concept of a "training set" for its development.

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

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

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