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5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.

Medical Display, MDM2010-5NC is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system.

The provided document describes a 510(k) premarket notification for a medical display device, the Medical Display, MDM2010-5NC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical study with specific acceptance criteria in the way a novel AI algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical display, the "acceptance criteria" revolve around its technical specifications being comparable to or meeting the standards for general medical image display and specifically digital mammography. The "reported device performance" is essentially its listed technical capabilities that demonstrate it meets these general requirements and is equivalent to the predicate.

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

• Not Applicable. This is a hardware device (a monitor), not an AI algorithm evaluated on a test dataset of medical images. The evaluation is primarily based on technical specifications and comparison to a predicate device.

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

• Not Applicable. See point 2.

4. Adjudication Method for the Test Set

• Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a medical display, not an AI-powered diagnostic algorithm. There is no AI component or human reader performance study mentioned.

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

• Not Applicable. This is a hardware monitor. There is no algorithm to evaluate in standalone mode.

7. The Type of Ground Truth Used

• Not Applicable. For this device, the "ground truth" is its technical specifications and compliance with industry standards for medical displays. There isn't a diagnostic "ground truth" in the sense of a disease state.

8. The Sample Size for the Training Set

• Not Applicable. No training set is used for a medical display device.

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

• Not Applicable. No training set is used for a medical display device.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the Substantial Equivalence (SE) determination made by the FDA based on the 510(k) submission.

The core of the study is a comparison to a predicate device:

• Predicate Device: RadiForce G51 21.3" 5MP Monochrome LCD Monitor by EIZO NANAO CORPORATION. (K042755).
• Methodology: The manufacturer (CHILIN TECHNOLOGY CO., LTD.) submitted technical specifications and a justification that their device (MDM2010-5NC) has the "same intended use as the predicate device" and that they "both share similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."
• Conclusion: The FDA reviewed these claims and, finding the device substantially equivalent to the legally marketed predicate, allowed it to proceed to market. This means the FDA agreed that the MDM2010-5NC's technical performance and intended use are sufficiently similar to the predicate that it meets the necessary safety and effectiveness standards without requiring a new, extensive clinical trial.

In essence, for this type of device, the "acceptance criteria" are implicitly met by demonstrating that the device is technically comparable to a device already deemed safe and effective for its stated indications for use.

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2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

The provided text describes a 510(k) premarket notification for a medical display device (MDC2130-2HC). However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to AI performance, ground truth, or sample sizes for a study.

The document is a regulatory submission for a display monitor, which does not typically involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that AI/CAD devices require. The core of this submission is to demonstrate substantial equivalence to a predicate device based on its intended use and general characteristics, not on a clinical performance study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred:

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

• Acceptance Criteria: Not explicitly stated as performance criteria but inferred from the "sameness" claim to the predicate device. The primary acceptance criterion for a display is likely its ability to accurately and reliably display medical images. This would include resolution, color/grayscale accuracy (e.g., DICOM GSDF adherence), brightness, contrast, and stability over time.
  • Inferred Technical Acceptance Criteria:
    • Resolution: 2 mega pixel (1600 x 1200)
    • Gamma settings: DICOM GSDF Gamma settings (1.8, 2.0, 2.2)
• Reported Device Performance:
  • Resolution: 2 mega pixel (1600 x 1200)
  • Gamma settings: Supports DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2.
  • Intended Use: Displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS.

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

• Not applicable. This document describes a medical display, not a diagnostic AI device that would undergo a test set evaluation for diagnostic performance. The substantial equivalence argument relies on comparing technical specifications and intended use, not clinical performance data from a patient cohort.

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

• Not applicable. See point 2.

4. Adjudication method for the test set:

• Not applicable. See point 2.

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

• No. This is a medical display, not an AI device. An MRMC study would not be conducted for this type of product.

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

• No. This is a hardware device (display), not an algorithm.

7. The type of ground truth used:

• Not applicable. The "ground truth" for a medical display typically relates to objective display characteristics (e.g., a calibrated photometer verifying luminance levels and DICOM GSDF curve adherence) rather than diagnostic outcomes. These tests are typically performed in a lab setting rather than using patient data with expert-established ground truth.

8. The sample size for the training set:

• Not applicable. This is a hardware device and does not involve AI model training.

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

• Not applicable. See point 8.

Study Proving Acceptance Criteria:

The document states: "Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."

This statement implies that the "study" proving the device meets acceptance criteria is primarily a comparison to a legally marketed predicate device (MDC1900-1LG), demonstrating "substantial equivalence." The acceptance criteria are essentially met by demonstrating that the new device's technical specifications and performance are comparable to the predicate, and that any differences do not introduce new safety or effectiveness concerns. There is no detailed study methodology or results provided within this summary for either device. Regulatory submissions for display monitors typically include technical specifications and adherence to relevant industry standards (e.g., DICOM Part 14 for grayscale display, resolution standards) rather than clinical performance studies.

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2MP Medical Monochrome Reference Display, MDM2130-2NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

2MP Medical Monochrome Reference Display - MDM2130-2NC.

The provided text does not contain information about acceptance criteria for a medical device or a study proving that the device meets those criteria.

Instead, the document is a 510(k) clearance letter from the FDA for a medical display (MDM2130-2NC). It states that the device has been found substantially equivalent to a predicate device and lists the standards it has met (Safety 60601-1, EMC - EN 60601-1-2, ITE Safety/EMC – EN 60950-1, CE, FCC), as well as DICOM conformance.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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3MP Mcdical Monochrome Reference Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

The provided document is a 510(k) premarket notification for a medical display, not a study evaluating a device's performance against acceptance criteria for an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI development and evaluation is not present in this document.

The document primarily focuses on establishing "substantial equivalence" of the Medical Display, MDM2130-3NC, to a predicate device (MDM1900-1NR) based on similar intended use and characteristics. It does not contain information about a clinical trial or performance study typical for AI/CAD devices.

Here's an analysis of the provided information, noting what is present and what is missing based on your request:

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

• Not Applicable / Not Provided. This document is for a medical display device, not an AI algorithm. It does not include specific performance metrics (like sensitivity, specificity, AUC) or acceptance criteria typically associated with AI device evaluation. The "performance" assessment here is a declaration of 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 Provided. No test set data or provenance information is included as this is not a performance study for an AI algorithm.

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 Provided. Ground truth establishment is not relevant for this type of device submission.

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

• Not Provided. Adjudication methods for test sets are not relevant for this type of device submission.

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 Provided. No MRMC study was conducted or mentioned, as this is not an AI-assisted diagnostic device.

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

• Not Provided. This is not an algorithm; it's a display monitor.

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

• Not Provided. Ground truth generation is not applicable to a medical display device.

8. The sample size for the training set

• Not Provided. No training set is mentioned or applicable.

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

• Not Provided. No training set or ground truth establishment relevant to AI is mentioned.

Summary of what is available in the document:

• Device Name: Medical Display, MDM2130-3NC
• Intended Use: To display images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Explicitly stated as "not suitable for a digital mammography system."
• Predicate Device: Medical Display - MDM1900-1NR (K061303)
• Conclusion: The device is substantially equivalent to the predicate device, sharing similar characteristics with minor differences that "do not raise new questions of safety and effectiveness."
• Regulatory Classification: Class II, 21 CFR 892.2050 (System, Image Processing, Radiological).

This document serves as a regulatory submission for a display device, focusing on its equivalence to an already approved device rather than clinical performance testing against specific diagnostic criteria.

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