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21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

MS23i2 (ML21023) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

The provided text describes a 510(k) premarket notification for a medical display monitor and does not concern an AI/ML device or a device that undergoes a clinical study with acceptance criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.

Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not applicable to this submission.

The submission is for a 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) intended for displaying and viewing medical images for diagnosis. The nature of the device means its "performance" is primarily assessed through technical specifications and compliance with relevant standards rather than diagnostic accuracy.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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

   • Not Applicable in the traditional diagnostic sense. This device is a monitor. Its "performance" would be assessed against technical specifications (e.g., resolution, luminance, contrast, uniformity, grayscale reproduction) and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function, IEC 60601-1 for electrical safety). The document does not provide a table with these technical acceptance criteria or reported performance values. It only states the display resolution (1200 x 1600 / 1600 x 1200) and that it is a monochrome 2M pixel LCD monitor.

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

   • Not Applicable. As this is a display monitor, there is no "test set" of medical images in the context of evaluating a diagnostic algorithm's performance. The evaluation would be based on the physical characteristics and software functionality of the monitor itself.

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. No ground truth establishment related to diagnostic accuracy is relevant for a medical display monitor.

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 is a hardware device (monitor), not an AI-assisted diagnostic tool.

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

   • Not Applicable. There is no algorithm in this product that would be evaluated in a standalone capacity.

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

   • Not Applicable.

8. The sample size for the training set

   • Not Applicable. There is no algorithm to train.

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

   • Not Applicable.

Summary based on available information:

The K113443 submission for the TOTOKU MS23i2 (ML21023) monitor is a 510(k) premarket notification for a medical display device. The "study" proving it meets acceptance criteria typically involves demonstrating that the device's technical specifications and performance meet established standards for medical monitors and are substantially equivalent to a predicate device.

• Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
• Predicate Device: 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) (K081945).
• Substantial Equivalence: The applicant states that the MS23i2 (ML21023) shares the same characteristics with its predicate device MS21i2 (K081945) except for the main board and power supply. This means the primary "study" involved comparing the technical specifications and, presumably, testing the performance aspects (like luminance, contrast, resolution, DICOM conformance) of the new device against the predicate and relevant standards.

Without further information from the full 510(k) submission, specific technical acceptance criteria and their measured values for items like luminance, uniformity, or DICOM conformance cannot be provided. However, the nature of the device means these are the types of criteria that would be assessed.

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21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).

This document focuses on the 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monochrome digital mammography LCD monitor. This device is a display monitor and, as such, does not undergo the same type of performance studies (e.g., diagnostic accuracy studies with human readers, AI algorithms, and clinical outcomes) as a diagnostic imaging device or an AI-powered diagnostic algorithm.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context will refer to the technical specifications and standards that a medical display monitor must meet to be considered safe and effective for its intended use, particularly for mammography. The 510(k) summary provided here does not detail a clinical study with patients, readers, or AI algorithms; rather, it asserts substantial equivalence to predicate devices based on technical characteristics.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details, ground truth for training set) are not applicable or not provided in the context of a 510(k) for a display monitor.

Here's an interpretation based on the provided document and general understanding of medical display regulatory submissions:

Acceptance Criteria and Device Performance for TOTOKU MS31i2 (MDL2128A)

This 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monitor focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical performance study with defined acceptance criteria for diagnostic accuracy. For a display monitor, acceptance criteria are typically related to its physical and performance specifications that ensure images are displayed accurately and consistently for medical diagnosis, especially in demanding fields like mammography.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria are implicitly tied to the performance characteristics being equivalent to the predicate devices and meeting relevant standards for display of medical images. Specific quantitative acceptance criteria are not detailed in this summary, but the device description highlights key specifications.

Study to Prove Acceptance Criteria:

The "study" to prove the device meets acceptance criteria in this context is the substantiation of substantial equivalence to legally marketed predicate devices, ME551i2 (K061447) and MS51i2 (K071794). This involves demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

For medical display monitors, this typically involves:

• Technical Bench Testing: Verifying that the monitor meets its published specifications (e.g., luminance, contrast ratio, uniformity, color stability for color displays, resolution, grayscale reproduction accuracy according to DICOM Part 14 standard).
• Compliance with Standards: Demonstrating adherence to relevant industry and regulatory standards for medical devices and displays (e.g., DICOM Part 14, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
• Comparison to Predicate Device Specifications: A direct comparison of the technical specifications of the new device against the predicate device to establish equivalence.

The 510(k) summary itself states: "MS31i2 (MDL2128A) shares the same characteristics with our predicate device ME551i2 (K061447) and MS51i2 (K071794)." This statement is the core of the "proof" from the regulatory perspective provided in this document.

Regarding the specific questions that are not directly applicable to a display monitor 510(k) from the provided text:

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 / Not provided. This device is a display monitor, not a diagnostic algorithm or imaging system that processes patient data. The "test set" would refer to a set of technical tests on the display hardware itself, 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 (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth, in the sense of clinical diagnoses or pathology, is not established for a display monitor. Technical experts and engineers would evaluate the monitor's performance against technical specifications.

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

• Not applicable / Not provided. Adjudication is relevant for clinical studies where multiple readers interpret images.

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 monitor, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable / Not provided. The "ground truth" for a display monitor's performance would be objective measurements against technical standards (e.g., luminance measurements, spatial resolution charts, grayscale step tests), not clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a monitor, not a machine learning algorithm requiring a training set.

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

• Not applicable. This device is a monitor.

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21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.

This document describes the 510(k) summary for a medical display device, the 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A). The information provided is primarily focused on the device's technical specifications and its substantial equivalence to a predicate device, rather than a detailed clinical study demonstrating its performance in a diagnostic context.

Therefore, much of the requested information regarding clinical study methodology (sample size, expert qualifications, adjudication, MRMC studies, training set details) is not available in the provided text, as it doesn't describe such a study for this display monitor. The acceptance criteria and "reported device performance" are more about the display's technical capabilities validating its suitability for medical imaging rather than a direct measure of diagnostic accuracy.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document does not describe a clinical test set or diagnostic study involving a sample of patient data. The "study" here refers to the technical validation of the display monitor itself against predetermined specifications and comparison to a predicate device.

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

• Not Applicable. There is no mention of experts establishing ground truth for a test set in the context of a diagnostic study for this device. The assessment revolves around the monitor's technical compliance and substantial equivalence to a predicate.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method for diagnostic performance is described.

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

• No. This is a passive display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics.

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

• Not Applicable in the traditional sense of a diagnostic study. For this device, the "ground truth" would be the required technical specifications for medical display monitors and the performance characteristics of the predicate device (K063199). The device's performance is measured against these technical standards.

8. The sample size for the training set

• Not Applicable. As a display monitor, there is no AI algorithm being trained, and thus no training set.

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

• Not Applicable. Refer to point 8.

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21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.

This document describes the 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A). This submission establishes substantial equivalence to a predicate device and does not detail a study proving the device meets specific acceptance criteria in the sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader agreement.

The device is a medical image display monitor. For such devices, acceptance criteria typically relate to technical performance specifications (e.g., luminance, contrast, resolution, uniformity, color accuracy) rather than diagnostic performance in a clinical study. The provided text does not include a table of acceptance criteria or a study proving the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on shared characteristics.

Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training/test sets, are not applicable or not provided in this regulatory submission for a display monitor.

Here's a response based on the information provided in the input:

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

The provided 510(k) summary does not include a table of specific quantitative acceptance criteria (e.g., specific luminance levels, contrast ratios, or color accuracy metrics) or a study reporting the device's performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to a predicate device.

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

Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study with a test set of data/images.

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. This 510(k) summary for a medical monitor does not describe a clinical performance study with ground truth established by experts.

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

Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study 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. This 510(k) summary is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not 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 a diagnostic algorithm.

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

Not applicable. This 510(k) submission for a display monitor does not involve a clinical study requiring ground truth for diagnostic accuracy.

8. The sample size for the training set

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

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

Not applicable. This device is a display monitor and does not involve machine learning or a training set with ground truth.

Summary of Device and Evidence Presented in 510(k):

The 510(k) submission for the 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) establishes substantial equivalence to its predicate device, the 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065).

The basis for acceptance (regulatory clearance) is the demonstration of substantial equivalence. The argument for substantial equivalence is that the new device shares the "same characteristics" as the predicate device, with differences only in power supply, front bezel, frame, fan, PCB, and LCD screen. These differences are presumably not considered to affect the fundamental performance parameters relevant to its intended use for displaying and viewing medical images for diagnosis.

No specific quantitative acceptance criteria or detailed performance study results are provided in the excerpt. The regulatory submission relies on the established equivalence to a previously cleared device that meets the general controls and requirements for medical image display.

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19-inch (48cm) Color LCD Monitor CDL1904A is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

CDL1904A is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.

This document is a 510(k) summary for the TOTOKU 19-inch (48cm) Color LCD Monitor CDL1904A. As such, it does not contain acceptance criteria or a study proving device performance in the way a clinical trial or performance study report for an AI/ML medical device would.

The information provided describes a medical monitor, which is a display device, not an AI algorithm or a diagnostic tool that provides performance metrics like sensitivity, specificity, or AUC. The concept of "acceptance criteria" for this device would relate to its technical specifications and conformity to industry standards for medical displays, not to its diagnostic performance.

Here's an analysis based on the provided text, addressing the points where applicable, and explaining why other points are not relevant:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. For a medical display monitor like the CDL1904A, acceptance criteria would typically involve technical specifications such as:

• Resolution: (e.g., SXGA 1280 x 1024 as stated in the device description)
• Luminance/Brightness: (e.g., cd/m²)
• Contrast Ratio:
• Color Accuracy:
• Viewing Angle:
• Uniformity:
• Pixel defect criteria:
• Compliance with medical display standards: (e.g., DICOM Part 14 Grayscale Standard Display Function, which is often a requirement for medical monochrome displays, though this is a color display).

The document states the device has "a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024" and is "compliant with VESA standard display mode." This is a description of its capability, not a set of acceptance criteria or performance against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a display device, not an algorithm that processes data. There is no "test set" of medical images or data for performance evaluation in this context.

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. There is no ground truth, as this is a display device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no ground truth or test set for 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. This is a display device, not an AI algorithm.

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

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this is a display device.

8. The sample size for the training set
Not applicable. This is a display device, not an AI algorithm.

9. How the ground truth for the training set was established
Not applicable. This is a display device, not an AI algorithm.

Summary from the provided document:

The 510(k) summary indicates that the TOTOKU CDL1904A is a 19-inch Color LCD Monitor intended for use with PACS for medical imaging applications, excluding digital mammography. The basis for its clearance is substantial equivalence to an existing predicate device, the ME183L (K030272). The substantial equivalence is claimed because the CDL1904A has "almost the same characteristics as TOTOKU's predicate device ME183L (K030272) except for the panel, molds and boards." This implies that the engineering and performance characteristics are comparable to a previously cleared device, satisfying regulatory requirements without needing a new clinical performance study for image interpretation.

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