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The Apple iMac 27" 5K Retina with PL4.0 is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.

The device can NOT be used in mammography.

The device can NOT be used for a life-support system.

The device is intended for prescription use.

The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) is a computer with color display for medical viewing.

It is combined with QUBYX PerfectLum 4.0 and PerfectLum remote management, a user- friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.

This report describes the acceptance criteria and the study proving the device meets these criteria based on the provided text.

Acceptance Criteria and Device Performance

The device under review, the Apple iMac 27" 5K Retina with PL4.0, is compared against a predicate device, the DELL UP3017 With QUBYX PerfectLum Bundle. The key performance criteria for medical image display systems are compliance with DICOM Part 14 GSDF and AAPM TG18 standards.

Study Information

The acceptance criteria were met through a performance study that assessed the device's compliance with established industry standards for medical displays.

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

• Sample Size: The document does not specify a "sample size" in terms of a number of devices tested. The testing appears to have been conducted on a single instance of the Apple iMac 27" 5K Retina with PL4.0.
• Data Provenance: The data is reported as being generated from tests performed on the device itself. The country of origin of the data is not explicitly stated, but the submission is for the U.S. FDA, and the company is based in Wilmington, Delaware, USA. The study is prospective in nature as it involves testing a specific device to confirm its performance.

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

• Not applicable as the ground truth for this device's performance is objective and based on established technical standards (DICOM Part 14 GSDF and AAPM TG18). The "ground truth" is defined by these standards, not expert consensus on image interpretation.
• For the AAPM TG18 test, a "user" analyzed test patterns and recorded answers, implying a single, presumably trained, individual performed the visual assessment portion of the test. Qualifications are not specified beyond being able to follow the test procedure.

4. Adjudication method for the test set:

• Not applicable. The tests are objective, with comparison of measured and visually assessed data against predefined target values from the DICOM and AAPM TG18 standards. There is no mention of multiple reviewers requiring an adjudication method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a display system, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance does not apply.

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

• Not directly applicable in the terms of an "algorithm only" as typically seen with AI. However, the DICOM conformance test involved the QUBYX PL 4.0 software generating the test procedure, measuring display characteristics with an X-Rite i1 Display Pro, and then the software analyzing results against DICOM standard target values, generating a report. This part of the test is highly automated and "standalone" in its assessment of compliance.
• The AAPM TG18 test also involved software-generated procedures and meter measurements, but it also included "visual parts" where a user analyzed test patterns and recorded answers. So it was not entirely standalone without human-in-the-loop for the AAPM TG18 test.

7. The type of ground truth used:

• The ground truth for both DICOM and AAPM TG18 compliance is defined by the respective technical standards (DICOM Part 14 GSDF and AAPM TG18). For the DICOM test, it was a comparison against "target values, defined by DICOM standard." For the AAPM TG18 test, it was a comparison against "target values, defined by AAPM standard."

8. The sample size for the training set:

• Not applicable. This device is a display system and does not involve AI or machine learning algorithms that require a "training set." The PerfectLum software is for calibration and verification, not for image analysis or diagnosis.

9. 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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