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The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

MDCC 2121 is a 21.3" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

The provided document is a 510(k) summary for the Barco MDCC 2121 display system. It's a pre-market notification to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific performance criteria through clinical trials or extensive standalone evaluation.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies are not applicable to this type of regulatory submission. This document focuses on demonstrating that the new device (MDCC 2121) is technically similar to an already approved device (MFGD 2621) and therefore does not require a new, full-scale clinical evaluation.

Here's a breakdown of what can be extracted and why other parts are not available in this document:

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

The document does not provide a table of explicit acceptance criteria with quantitative performance metrics. This is because it's a submission for substantial equivalence based on technical characteristics, not a clinical performance study with predefined success/failure thresholds for a new, unproven technology.

Instead, the "performance" is implicitly demonstrated through the statement: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use."

The relevant technical characteristics mentioned are:

• Resolution: 1600x1200 pixels
• Panel type: 21.3" color LCD display
• Software: MediCal QAWeb Agent for optimization, DICOM-compliant viewing, calibration, and display test patterns.

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 does not describe a test set or data provenance in the context of a clinical performance study. The "test" for substantial equivalence is a comparison of technical specifications and intended use against a predicate device.

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 test set or ground truth established in this document for the purpose of evaluating diagnostic performance. The ground truth for this submission is based on the established safety and efficacy of the predicate device.

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

Not applicable. No test set requiring outcome adjudication 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

Not applicable. The MDCC 2121 is a display system, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI or new diagnostic methods, which is beyond the scope of this device's intended use and the nature of this 510(k) submission.

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

Not applicable. The MDCC 2121 is a display system and does not involve an algorithm that performs diagnostic functions independently. It is explicitly "intended to be used in displaying and viewing digital images for review by trained medical practitioners," indicating human-in-the-loop operation.

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

Not applicable. Ground truth for diagnostic performance is not relevant for this regulatory submission, which focuses on the display's technical functionality and equivalence. The "ground truth" for the submission is the predicate device's previously established safety and efficacy for its intended use.

8. The sample size for the training set

Not applicable. The MDCC 2121 is a display system 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. As there's no training set, there's no ground truth to establish for one.

Summary of what can be extracted from the document:

This 510(k) summary describes a display system (MDCC 2121) and argues for its substantial equivalence to a predicate device (MFGD 2621) based on technical characteristics and intended use. It explicitly states it is for "displaying and viewing digital images for review by trained medical practitioners" and "must not be used in primary image diagnosis in mammography." The document does not contain information about clinical acceptance criteria, performance studies, sample sizes, or ground truth in the context of diagnostic accuracy, as these are not required for demonstrating substantial equivalence for this type of device.

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