Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.

Device Description

Sonix Health comes with the following functions:

Checking ultrasound multiframe DICOM
Echocardiography multiframe DICOM classification and automatic measurement.
Verification of the results and making adjustments manually.
Providing the report for analysis

Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network.

Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning according to the view. The deep learning algorithms for the second step are categorized as B-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.

AI/ML Overview

Based on the provided text, here's a detailed description of the acceptance criteria and the study that proves the device meets them:

Device Name: Sonix Health
Intended Use: Quantifying and reporting echocardiography for use by or on the order of a licensed physician. Accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Indicated for use in adult populations. Ultrasound images are acquired via B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.

Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implicit from "passed the test")	Reported Device Performance
View Recognition Accuracy	High accuracy (implicitly needed to "pass the test").	Average accuracy of 98.22%
Correlation Coefficient (Manual vs. AI Measurements)	High correlation (implicitly needed to "pass the test").	93.98% average correlation coefficient when compared to manual measurements by participating experts.

Study Details

A table of acceptance criteria and the reported device performance: (See table above)
Sample size used for the test set and the data provenance:
- Total Test Images: 2,744 images
  - B-mode: 476 images
  - M-mode: 243 images
  - Doppler: 2,025 images
- Data Provenance:
  - Country of Origin: 2,648 (96.5%) from American participants; 1,264 (47.7%) from a U.S. hospital and 1,384 (52.3%) from a South Korea hospital (note: the percentages for US and South Korea seem to describe the total "American participants" data, not the overall 2,744 images. There's a slight ambiguity, but the majority is clearly US-based).
  - Retrospective/Prospective: Not explicitly stated, but "collected from six centers" and "data was collected" implies retrospective collection of existing data for the test set.
  - Demographics: For American participants: 65% male and 35% female. Overall representative institution data showed 50.2% male, average BMI of 22.2, and 67.0% LVEF. The LVEF range for the validation datasets was 14% to 76%, with a mean of 58% and a standard deviation of 11%.
  - Equipment: Data acquired using equipment from four manufacturers.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Annotators: Two experienced sonographers with a Registered Diagnostic Cardiac Sonographer (RDCS) certification.
- Supervising Experts: Two experienced cardiologists. The qualifications (e.g., years of experience) for these cardiologists are not specified beyond "experienced."
Adjudication method for the test set:
- The "consensus annotation" of the two experienced sonographers (supervised by two cardiologists) was used as the final ground truth. This implies a consensus-based adjudication, but the specific process (e.g., if initial disagreements were resolved through discussion or a third expert) is not detailed. It's essentially a (2+0) or (2+supervision) model.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No MRMC comparative effectiveness study was done to assess human reader improvement with AI assistance. The performance testing focused on the standalone algorithm's accuracy and correlation with manual measurements (ground truth), not human-AI collaboration. The document explicitly states: "No clinical testing conducted in support of substantial equivalence..."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance metrics related to "view recognition accuracy" and "correlation coefficient when compared to manual measurements by participating experts" demonstrate a standalone evaluation of the algorithm's output against established ground truth. The device "utilizes artificial intelligence to automate previous manual quantification tasks" and then "users can review and modify the results if necessary," but the performance metrics reported are for the automated results before clinician modification.
The type of ground truth used:
- The ground truth for the test set was established through expert consensus (two experienced sonographers with RDCS certification, supervised by two experienced cardiologists). The "consensus annotation" was used as the final ground truth. This is a form of expert consensus.
The sample size for the training set:
- The exact sample size (number of images or studies) for the training data is not explicitly stated. It mentions that "The training data was collected from six centers" and indicates demographic information for "the representative institution."
How the ground truth for the training set was established:
- The document implies that the "training data" and "validation data" (test set) are distinct and independent. While it details the ground truth establishment for the test set (expert sonographer consensus supervised by cardiologists), it does not explicitly describe how the ground truth for the training set was established. It's reasonable to infer a similar process of expert annotation, but it's not confirmed in the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ontact Health Co., Ltd. Hyuk-Jae Chang CEO 5f, 50-5, Ewhayeodae-gil, Seodaemun-gu Seoul, KS013/03764 Korea. South

Re: K230209

October 20, 2023

Trade/Device Name: Sonix Health Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: October 19, 2023 Received: September 21, 2023

Dear Hyuk-Jae Chang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).

Sincerelv.

Jessica Lamb

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230209

Device Name Sonix Health

Indications for Use (Describe)

Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.

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 21 CFR 807.92]

1. Date

October 19, 2023

Submitter's Information & Contact Person 2.

Submitter: ONTACT HEALTH Co., Ltd.
Address: 5F Erom Tower, 50-5, Ewhayeodae-gil, Seodaemun-gu, Seoul, 03764, Republic of Korea
Contact Person: Hyuk-Jae Chang / CEO
Telephone No.: +82-2- 362-9610
Email Address: ontact(01@ontacthealth.com

Trade Name, Common Name, Classification 3.

Workstation Software for cardiac ultrasound image review, analysis, and reporting - Common name:
Trade name: Sonix Health

Classification Description	21 CFR Section	Product Code
Automated Radiological Image Processing Software	21 CFR 892.2050	QIH, LLZ

As stated in 21 CFR parts 892.2050 of the device has been classified as Class II.

4. Identification of Predicate Device(s)

The identified predicate devices within this submission are shown as follow:

Predicate Device

510(k) Number: K213544 .
Trade/Device name: TOMTC-ARENA
Manufacturer: TOMTEC Imaging Systems GmbH .

Reference Device

. 510(k) Number: K220975
. Trade/Device name: V8 Diagnostic Ultrasound System,
Manufacturer: Samsung Medison Co., Ltd. .

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Description of the Device 5.

Sonix Health comes with the following functions:

Checking ultrasound multiframe DICOM
Echocardiography multiframe DICOM classification and automatic measurement.
Verification of the results and making adjustments manually.
Providing the report for analysis

Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network.

Image /page/4/Figure/7 description: The image shows a diagram of a local area network with a personal computer connected to a NAS. The personal computer has a Sonix Health application running on it. The Sonix Health application has a Windows application and an AI Engine. The Windows application and AI Engine are connected to each other.

6. Indications for Use

Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.

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7. Determination of Substantial Equivalence

The identified predicate devices within this submission is shown in the following table:

Description	Decision	Subject Device (K230209)	Predicate Device (K213544)	Reference Device (K220975)
Trade/Device name		Sonix Health	TOMTEC-ARENA	V8 Diagnostic Ultrasound System
Product Code		QIH (Subsequent Product Code: LLZ)	QIH (Subsequent Product Code: LLZ)	IYN, IYO, ITX
Regulatory Class	SE	2	2	2
Regulation Number		21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.1550, 892.1560, 892.1570
Intended use	SE	Sonix Health is intended for quantifyingand reporting echocardiography for use byor on the order of a licensed physician.Sonix Health accepts DICOM-compliantmedical images acquired from ultrasoundimaging devices. Sonix Health is indicatedfor use in adult populations.Ultrasound images are acquired via the B(2D), M, Pulsed-wave Doppler, andContinuous-wave Doppler modes.	TOMTEC-ARENA software is aclinical software package designed forreview, quantification and reporting ofstructures and function based on multi-dimensional digital medical dataacquired with different modalities.TOMTEC ARENA is not intended tobe used for reading of mammographyimages.	The V8 / V7 diagnostic ultrasound system andprobes are designed to obtain ultrasound imagesand analyze body fluids.The clinical applications include: Fetal/Obstetrics,Abdominal, Gynecology, Intra-operative, Pediatric,Small Organ, Neonatal Cephalic, Adult Cephalic,Trans-rectal, Trans-vaginal, Muscular-Skeletal(Conventional, Superficial), Urology, CardiacAdult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.It is intended for use by, or by the order of, and
Indications for use	SE		Indications for use of TOMTEC-ARENA TTA2 software arequantification and reporting ofcardiovascular, fetal, abdominalstructures and function of patients withsuspected disease to support thephysician in the diagnosis	under the supervision of, an appropriately trainedhealthcare professional who is qualified for directuse of medical devices. It can be used in hospitals,private practices, clinics and similar careenvironment for clinical diagnosis of patients.Modes of Operation: 2D mode, Color Dopplermode, Power Doppler (PD) mode, M mode, PulsedWave (PW) Doppler mode, Continuous Wave(CW) Doppler mode, Tissue Doppler Imaging(TDI) mode, Tissue Doppler Wave (TDW) mode,ElastoScan Mode, Combined modes, Multi-Imagemode (Dual, Quad), 3D/4D mode.
Where used(hospital, home,ambulance, etc.)	SE	Inside of hospitals, clinics, and physician'soffices.	Inside and outside of Hospitals,Clinics, and Physician's offices.	Inside of hospitals, clinics, and physician's offices.
Applicationdescription	SE	Sonix Health utilizes artificial intelligenceto automate previous manual quantificationtasks, resulting in increased efficiency forusers. Our system performs view	IMAGE-COM is a basic module forreviewing and measuring digitalmedical data. It supports routineworkflows for loading, analyzing and	The V8 / V7 are a general purpose, mobile,software controlled, diagnostic ultrasound system.Their function is to acquire ultrasound data and todisplay the data as 2D mode,Color Doppler mode,
Description	Decision	Subject Device (K230209)	Predicate Device (K213544)	Reference Device (K220975)
		classification and measurements accordingto the US ASE guidelines, and the userscan review and modify the results ifnecessary.	saving medical studies, e.g. for thepurpose of creating reports. IMAGE-COM is where basic measurements canbe performed and the entry point foradvanced analysis modules. Studyrelated routine measurements can beimported, displayed, edited andexported to accompanying reportingsystems.	Power Doppler (PD) mode, M mode, Pulsed Wave(PW) Doppler mode, Continuous Wave (CW)Doppler mode, Tissue Doppler Imaging (TDI)mode, Tissue Doppler Wave (TDW) mode,ElastoScan Mode, Combined modes, Multi-Imagemode(Dual, Quad), 3D/4D mode. The V8 / V7 alsogive the operator the ability to measure anatomicalstructures and offer analysis packages that provideinformation that is used to make a K223387Traditional 510(k) diagnosis by competent healthcare professionals. The V8 / V7 have a real timeacoustic output display with two basic indices, amechanical index and a thermal index, which areboth automatically displayed.
Semi-automatedview classification	SE	PLAX LV, A4C, A4C Zoomed LV, A2C,A2C zoomed LV, M-mode LA/Ao, M-mode LV, CW Doppler MS, CW DopplerMR, PW Doppler MV, CW Doppler AV,CW Doppler AR, CW Doppler TR, CWDoppler PV, CW Doppler PR, PW DopplerRVOT, PW Doppler LVOT, DTI MVannulus	PLAX LV, A4C, A4C Zoomed LV, A2C, A2Czoomed LV, M-mode LA/Ao, M-mode LV, CWDoppler MS, CW Doppler MR, PW Doppler MV,CW Doppler AV, CW Doppler AR, CW DopplerTR, CW Doppler PV, CW Doppler PR, PWDoppler RVOT, PW Doppler LVOT, DTI MVannulus	PLAX LV, A4C, A4C Zoomed LV, A2C, A2Czoomed LV, M-mode LA/Ao, M-mode LV, CWDoppler MS, CW Doppler MR, PW Doppler MV,CW Doppler AV, CW Doppler AR, CW DopplerTR, CW Doppler PV, CW Doppler PR, PWDoppler RVOT, PW Doppler LVOT, DTI MVannulus
Semi-automatedmeasurements	SE	IVSd (2D), IVSs (2D), LVIDd (2D),LVIDs (2D), LVPWd (2D), LVPWs (2D),LA (2D), Ao (2D), LVESV / LVEDV(4CH), LAV (4CH), LVESV / LVEDV(4CH), LVESV / LVEDV (2CH), LAV(2CH), LVESV / LVEDV (2CH), LA (m-mode), Aorta (m-mode), IVSd (m-mode),LVIDd (m-mode), LVPWd (m-mode),IVSs (m-mode), LVIIDs (m-mode),LVPWs (m-mode), MV Peak E Vel, MVPeak A Vel, MV Decel Time, e' (med), a'(med), s' (med), LVOT Vmax, LVOT VTI,RVOT Vmax, RVOT VTI, PV AccT, TRVmax, TR VTI, AR Vmax / PR Vmax, ARPHT / PR PHT, MV Vmax, MV VTI, MV,PHT, MR Vmax, MR VTI, AV Vmax / PVVmax, AV VTI / PV VTI, RVOT (2D)	B-Mode- Ao Asc diam, Ao Ann diam, Ao STJdiam, Ao SV diam, IVSd, LA diamsystole, LVIDd, LVIDs, LVOT diam,LVPWd, RVDd base (RVD1), RVDdmid (RVD2), RVLd, RVOT diam lax,RVOT diam prox, TV Ann diam ant-post, IVSd-LVIDd-LVPWd (Sameline)DOPPLER Mode- MV A Vel, MV E Vel, MV E/ASlope, (MV A Vel, MV E Vel, MVTime), MV Dec. Slope, (MV DecTime, MV E Vel), LVOT VTI, AVVTI, PV VTI, TR Vmax, LV E'(l), LVA'(l), LV E'(s), LV A'(s), RV A'(l),RV E'(l), RV S'(l)	(PLAX LV) - Interventricular septum diameter at thediastole and systole phase, LV internal diameter atthe diastole and systole phase, LV posterior walldiameter at the diastole and systole phase, Aortadiameter and LA diameter, (A4C) - LA Volume, LVVolume, (A4C Zoomed LV) - LV Volume, (A2C) -LA Volume, LV Volume, (A2C zoomed LV) - LVVolume, (M-mode LA/Ao) - LA diameter and Aortadiameter, (M-mode / LV) - Interventricular septumdiameter at the diastole and systole phase, LVinternal diameter at the diastole and systole phase,LV posterior wall diameter at the diastole and systolephase, (CW Doppler MS) - Vmax, VTI, PHT, (CWDoppler MR) - Vmax, VTI, (PW Doppler MV) - E.A, DT, (CW Doppler AV) - Vmax, VTI, (CWDoppler AR) - Vmax, PHT, (CW Doppler TR) -Vmax, VTI, (CW Doppler PV) - Vmax, VTI, (CWDoppler PR) - Vmax, EDV, (PW Doppler RVOT) –Vmax, VTI, (PW Doppler LVOT) - Vmax, VTI,(DTI MV annulus) - S', E', A'
Description	Decision	Subject Device (K230209)	Predicate Device (K213544)	Reference Device (K220975)
Semi-automationtechnology	SE	After the automated analysis is complete,users can review and modify the results asneeded. The product is intended for use by,or on the order of a licensed physician.	Semi-automated adultechocardiography 2D and Dopplermeasurements are generated using andartificial intelligence (AI) detectionalgorithm without user interaction.After measurement is generated, theuser can edit (manually adjust thecaliper positions), accept, or reject themeasurements. The automation ofmeasurements is constrained to thespecific imaging mode (2D, Doppler)as recommended by ASE guidelines.	After the analysis is complete, users can review andmodify the results as needed. The product is for useby, or on the order of a licensed physician.

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It is necessary for the end user to verify, confirm, and modify the analysis results when using Subject Device.

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8. Non-Clinical Test Summary

Performance Standards

Digital Imaging and Communications in Medicine (DICOM) Set (Ps3.1 - .20) IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices. IEC 62366-1 Edition 1.1 2020-06, Medical devices-Part 1 Application of usability engineering to medical devices.

Sonix Health is classified as a Moderate Level of Concern. The software verification and validation were conducted in compliance with IEC 62304 "Medical device software life cycle process" and the internal design control process to ensure safety and effectiveness. Throughout the verification and validation process, traceability was maintained, encompassing risk management (including Cyber Security and Usability).

Sonix Health was designed to assist clinicians in adult echocardiography examinations. The training data was collected from six centers. Among these, the demographic data from the representative institution showed 50.2% male participants, an average body mass index of 22.2, and 67.0% left ventricle ejection fraction.

The training data and validation data are distinct and independent. The ground truth annotation for the test was performed by two experienced sonographers with a Registered Diagnostic Cardiac Sonographer (RDCS) certification. The annotation was supervised by two experienced cardiologists and the consensus annotation was used as the final ground truth.

For performance testing, we used 476 B-mode clinical images, 243 M-mode clinical images, and 2,025 Doppler images, resulting in a total of 2,744 test images to assess these functions. Of these, 2,648 (96.5%) were from American participants. The data was respectively collected with 1,264 (47.7 %) from a U.S. hospital and 1,384 (52.3%) from a South Korea hospital. The gender distribution for the American participants was 65% male and 35% female. Data was acquired using equipment from four manufacturers.

The test was conducted blinded to private data, including patients' disease status. However, we measured LVEF based on the ground-truth of the validation datasets. The results showed that the left ventricle ejection fraction (LVEF) ranged from 14% to 76%, with a mean LVEF of 58% and a standard deviation of 11%. The normal LVEF (%) range for females is 54% to 74%, while for males it is 52% to 72%.

Sonix Health passed the test in two categories: an average accuracy of 98.22% for view recognition and a 93.98% average correlation coefficient when compared to manual measurements by participating experts.

Through verification and validation activities, Sonix Health is confirmed to meet all the design and performance requirements, ensuring safety and effectiveness without raising adverse issues. In conclusion, it demonstrates substantial equivalence.

Clinical Test Summary

No clinical testing conducted in support of substantial equivalence when compared to the predicate and reference devices.

9. Conclusion

In conclusion, all verification and validation activities demonstrated that the design specifications and technological characteristics of Sonix Health meet the applicable requirements and standards for the safety and effectiveness of the device for its intended use. As a result. Sonix Health is substantially equivalent to the currently marketed predicate device.

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).