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The MediCal LE device is intended to be used as a tool for trained medical practitioners to calibrate and perform QA checks on color displays in home offices and hospitals.

The MediCal LE device is a digital image quality management system

Acceptance Criteria and Study Details for Barco MediCal LE

Based on the provided documents, it is not possible to extract the detailed information requested regarding the acceptance criteria and a specific study proving the device meets those criteria. The provided 510(k) summary and FDA clearance letter primarily focus on establishing substantial equivalence to a predicate device and confirming the device's intended use and classification.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided documents. The 510(k) summary mentions "digital image quality management system" and "calibrate and perform quality checks on color displays," implying performance related to display calibration and quality assurance. However, specific performance metrics (e.g., luminance accuracy, color uniformity, spatial resolution targets) are not provided.
• Reported Device Performance: Not reported in the provided documents. The documents do not include any tables or descriptions of test results showing how well the MediCal LE performed against any criteria.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

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

• Not mentioned, as there is no description of a specific performance study or ground truth establishment process.

4. Adjudication Method for the Test Set:

• Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not mentioned. The device's nature as a display calibration and QA tool makes an MRMC study (typically for diagnostic image interpretation) less likely or applicable in this context. The focus would be on the device's ability to maintain objective display parameters.

6. Standalone Performance Study (Algorithm Only):

• A standalone study for the algorithm only (without human-in-the-loop performance) is implied to some extent, as the device is a software tool for calibration and QA. However, specific details of such a study are not provided. The documents state: "The MediCal LE device is a software tool used to calibrate and perform QA checks on image displays." This indicates the device's primary function is automated.

7. Type of Ground Truth Used:

• Not explicitly defined, as no specific performance study details are available. For a display calibration and QA tool, the "ground truth" would likely involve objective physical measurements of display characteristics (luminance, chromaticity, uniformity, etc.) using reference instruments that are themselves calibrated to established standards (e.g., DICOM Part 14, CIE color spaces).

8. Sample Size for the Training Set:

• Not mentioned. As a calibration and QA tool, it's less likely to involve a "training set" in the context of machine learning for image interpretation. Its "training" would be more akin to software development and validation that ensures it correctly applies calibration algorithms and performs measurement functions.

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

• Not mentioned. (See point 8 for context on "training set" applicability).

Summary of what is known from the provided documents:

• Device Name: MediCal LE
• Manufacturer: Barco NV Display Systems
• Intended Use: "A tool for trained medical practitioners to calibrate and perform quality checks on color displays in home offices and hospitals."
• Technological Characteristics: "A software tool used to calibrate and perform QA checks on image displays."
• Substantial Equivalence: Claimed to Barco NV Display Systems MediCal Display Conformity and Consistency Software (K982690). This is the primary basis for the 510(k) clearance, not a new performance study against specific acceptance criteria.

Conclusion:

The provided 510(k) documents for the Barco MediCal LE indicate that its clearance was based on substantial equivalence to a predicate device (K982690). They do not contain the specific details of acceptance criteria, detailed performance studies, sample sizes, or ground truth establishment methods that would typically be associated with a comprehensive performance evaluation demonstrating conformance to novel acceptance criteria. Such information would likely be found in internal validation reports or more detailed technical documentation not included in this summary.

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