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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance (Apple iMac 27" 5K Retina with PL4.0)
DICOM Part 14 GSDF Conformance	Successfully passed DICOM conformance test; compliant
AAPM TG18 Acceptance Test	Successfully passed AAPM TG18 acceptance test; compliant
Intended Use	Displaying and viewing medical images for review and analysis by trained medical practitioners. Not for mammography or life-support systems.
Screen Technology	Color IPS Retina
Active Screen Size (diagonal)	68 cm / 27"
Resolution	5120 x 2880
Pixel Pitch	0.1167 mm
Color Imaging	Yes
Gray Imaging	Yes
Maximum Luminance	500 cd/m2
DICOM Calibrated Luminance	350 cd/m2
Contrast Ratio (typical)	1000:1

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is placed inside a blue square. The text is stacked in three lines, with "ADMINISTRATION" on the bottom line.

% Marc Leppla Director Quantum Spectra LLC 501, Silverside Road St 105 Wilmington, Delaware 19809

June 2, 2020

Re: K200889

Trade/Device Name: Apple iMac 27" 5K Retina with PL4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 21, 2020 Received: April 3, 2020

Dear Marc Leppla:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200889

Device Name Apple iMac 27" 5K Retina with PL4.0

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary as required by 807.92

K200889

Company Identification

QUANTUM SPECTRA LLC 501 SILVERSIDE RD STE 105 WILMINGTON DE 19809

Official Correspondent

Mr. Marc Leppla President and CTO (Chief Technical Officer) marc@qs-group.net

Date of Submission 01/21/2020
Device Trade name Apple iMac 27" 5k Retina with PL 4.0
Common/Usual Name Image display system, Color LCD Monitor, image monitor/display

6, Classification Number Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and Communications System

7.Predicate device Name: DELL UP3017 With QUBYX PerfectLum Bundle Manufacturer: DELL and QUBYX 510(k) number: K171229 Classification Number: Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and Communications System

8. Device description

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

Image /page/3/Picture/16 description: The image is a logo featuring a light blue circle with a stylized design inside. The design appears to be a combination of geometric shapes and lines, possibly representing letters or abstract forms. The overall impression is modern and minimalist, with the light blue color giving it a clean and fresh look. The logo is simple, yet visually striking, making it easily recognizable.

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9. Indications for use

The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) 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.

10. Comparison of technological characteristics

Specification	Apple iMac 27" 5k Retinawith PL 4.0	DELL UP3017with PerfectLum
Screen technology	Color IPS Retina	Color TFT LCD Panel (IPS)
Active screen size (diagonal)	68 cm / 27"	30"
Resolution	5120 x 2880	2560 x 1600
Pixel pitch	0.1167 mm	0.25 mm
Color imaging	Yes	Yes
Gray imaging	Yes	Yes
Maximum luminance	500 cd/m2	350 cd/m2
DICOM calibrated luminance	350 cd/m2	300 cd/m2
Contrast ratio (typical)	1000:1	1000:1
Intended use	The Apple iMac 27″ 5k Retina withPL 4.0 is intended to be used fordisplaying and viewing medicalimages, for review and analysis bytrained medical practitioners.The device can NOT be used inmammography.The device can NOT be used for alife-support system.The device doesnot contact with the patient	The DELL U3017 withQUBYX PerfectLum isintended to be used fordisplaying and viewingmedical images, for reviewand analysis by trainedmedical practitioners. TheDELL U3017 can be usedonly in conjunction withQUBYX PerfectLum.The device can not be usedin primary image diagnosis inmammography.The device can not beused for a life-supportsystem. The device doesnot contact with the patient

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Details of testing:

To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PL 4.0 software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the DICOM standard. It consisted of measurement steps, where the meter measured display's characteristics and the software recorded them. Then the software analyzed the results in comparison with target values, defined by DICOM standard, and generated the report, stating that the display is DICOM-conformant.

The display device has successfully passed DICOM conformance test, so it is compliant with DICOM Part 14 GSDF standard. So is the predicate device, so the two devices are substantially equivalent in this regard.

To verify AAPM TG18 conformance, an acceptance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the AAPM TG18 standard and consisted of measurement and visual parts.

During the measurement steps, the meter measured display's characteristics and the software recorded them. During the visual steps, the user analyzed test patterns, generated by the software in accordance with AAPM standard. The software recorded the user's answers. Then the software analyzed the results in comparison with target values, defined by AAPM standard, and generated the report, stating that the display passes AAPM TG18 acceptance test.

The display device has successfully passed AAPM TG18 acceptance test, so it is compliant with AAPM TG18 standard and can be used as a primary category display for interpretation of medical images. The same is true for the predicate device, so the two devices are substantially equivalent in this regard.

Both devices have the same indications for use, except for predicate device it is not specified that it will not contact with the patient.

We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.

International standards: Directives: 2014/53/EU 2009/125/EC 2011/65/EU Safety and Health: EN 60950-1:2006+A1:2010+A11:2009+A12:2011+A2:2013 EN 50665:2017 2000-12-21 489-1 V2.2.0 EN 301 489-17 V3.2.0
RF Spectrum Efficiency: EN 300 328 V2.1.1 , EN 301 893 V2.1.1 , EN 300 440 V2.1.1
Additional Compliance: RoHS: EN50581:2012 , Ene

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Conclusion:

The comparison table shows that the subject device (Apple iMac 27" 5k Retina with PerfectLum 4.0) has the same intended use as the predicate. Although the devices have some different technological characteristics, as a higher resolution and higher maximum luminance, these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does.

Both devices are compliant with DICOM Part 14 GSDF and AAPM TG18 standards. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).