The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.

Device Description

The Surgical Navigation Advanced Platform (SNAP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.

The Surgical Navigation Advanced Platform (SNAP) transforms medical images into a dynamic, interactive 3D scene, and connects to external 3rd party surgical navigation systems (i.e. "validated systems"), to extract and display intra-operative surgical navigation information (such as the 3D navigation pointer) inside the generated 3D scene. Current navigation systems usually display the navigation data on 2D black and white DICOM imagery within the external navigation system itself. The SNAP displays the same navigation data (pointer position and orientation), as it is received from the external 3rd party navigation system. in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.

The SNAP allows surgeons to analyze and plan a specific patient's case before surgery, and then take that plan into the operating room (OR) and use it in conjunction with a validated traditional navigation system during surgery. The SNAP then presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. The surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controls such as rotate, zoom in and zoom out. During pre-operative use a virtual reality (VR) headset further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.

The SNAP product does not include any custom hardware and is a software-based device that runs on a high performance desktop PC assembled using "commercial off-the-shelf" components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Surgical Navigation Advanced Platform (SNAP):

Based on the provided text, the device is the Surgical Navigation Advanced Platform (SNAP), and the submission is for modifications to an existing cleared device (K140819). The modifications include adding support for X-ray 3D Angiography (XA) scans, incorporating a VR headset for intra-operative use (previously only pre-operative), and adding a video capture PCB and an "Endo View" GUI for displaying live endoscopy video side-by-side with 3D scenes.

It's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device (K140819) rather than presenting a standalone study with specific performance metrics against acceptance criteria for the entire device's functionality. The performance data mentioned are related to Electromagnetic Compatibility (EMC) and Software Verification and Validation Testing to ensure the modifications do not negatively impact the device's safety and effectiveness.

Here's a breakdown of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for the overall performance of the SNAP device (e.g., accuracy of segmentation, simulation fidelity). Instead, the acceptance criteria relate to regulatory compliance and the successful execution of specific tests for the modifications.

Acceptance Criteria (from text)	Reported Device Performance (from text)
DICOM Data Acceptance for XA Scans: 1) Image Modality file type is CT, MR or XA, and 2) Media Storage SOP Class and SOP Class UID are CT or MR (for scans exported as DICOM CT image storage type).	SNAP software verifies DICOM data meets these criteria; otherwise, data is rejected. (Implied: Successfully implemented and functioning as designed for XA support).
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2007 Third Edition to ensure the use of SNAP in the OR does not adversely affect other devices. (Specifically for the modified device, including the VR headset for intra-operative use).	"EMC evaluation per IEC 60601-1-2:2007 Third Edition was performed by a 3rd party test laboratory on the modified device and the SNAP was found to be in compliance." (No issues identified regarding the VR headset).
Software Verification and Validation Testing: Device continues to meet its intended use and performance requirements (for the modified SNAP). Adherence to FDA's "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices" for a "medium" level of concern device.	"The SNAP was fully tested, verified and validated by Surgical Theater... A formal verification and validation test plan was executed to confirm that the modified SNAP continues to meet its intended use and performance requirements." "Verification and validation results demonstrate the modified SNAP is as safe and effective as the predicate SNAP, and performs as intended..."
Product Risk Management: Performed in accordance with ISO 14971:2012; risk mitigations are implemented.	"Product risk management activities were performed in accordance with ISO 14971:2012... Risk management verification and validation consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations..."

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

Sample Size: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging studies for the performance validation. The testing described largely pertains to software verification, EMC, and risk management. The "DICOM data acceptance" for XA scans implies testing with various DICOM files, but a specific number is not provided.
Data Provenance: Not explicitly stated. The focus is on the software and hardware modifications rather than clinical data.

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

Number of Experts & Qualifications: Not mentioned in the provided text. The evaluation is focused on technical compliance and validation by the manufacturer, not a clinical ground truth assessment by external experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or mentioned. The described testing is technical validation and verification, not a clinical study requiring adjudication of outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study is not described in the provided text. The submission is for substantial equivalence of device modifications, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: The text does not describe a standalone performance study in the context of an algorithm's diagnostic or predictive capability. The SNAP device is described as a "software interface and image segmentation system" intended for simulation and surgical planning, interacting with a human surgeon. Its performance evaluation focuses on the accurate processing and display of data for human interpretation and use.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "DICOM data acceptance" related to XA scans, the ground truth would be adherence to the DICOM standard and the internal specifications for image modality and SOP Class. For software verification and validation, the ground truth is the predefined functional and performance requirements established by the manufacturer, verified through testing against those specifications (e.g., whether the software converts the image correctly, whether the display is accurate). There isn't a clinical "ground truth" (like pathology or outcomes data) discussed for this submission.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable or mentioned in the provided text. The SNAP device is described as an "image segmentation system," but the submission does not detail any machine learning or AI algorithm training that would require a distinct training set. The focus is on functionality and safety of the system as a whole.

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

Ground Truth for Training Set: Not applicable, as no training set for a machine learning algorithm is discussed.

Summary of Scope:

The provided document (K160584) describes a 510(k) submission for modifications to an existing cleared device. The "performance data" presented are primarily focused on demonstrating that these modifications do not introduce new safety or effectiveness concerns and that the modified device remains in compliance with relevant technical standards (EMC) and internal software verification and validation processes. It is a regulatory submission for substantial equivalence, not a detailed clinical study report on the device's diagnostic or therapeutic performance.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2016

Surgical Theater, LLC % Mr. Kevin M. Murrock Director of Project Management 781 Beta Drive MAYFIELD VILLAGE, OH 44143

Re: K160584

Trade/Device Name: Surgical Navigation Advanced Platform (SNAP) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2016 Received: May 24, 2016

Dear Mr. Murrock:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160584

Device Name Surgical Navigation Advanced Platform (SNAP)

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image features a logo for "Surgical Theater." The logo consists of a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver or gray, with a section on the right side colored gold. Below the ribbon graphic, the words "SURGICAL" and "THEATER" are stacked vertically, with each word in a sans-serif font and a gold color.

510(K) SUMMARY AS REQUIRED BY SECTION 807.92

Purpose of Submission.

Surgical Theater, LLC hereby submits this 510/k) premarket notification to obtain a determination of substantial equivalence for modifications to our Surgical Navigation Advanced Platform (SNAP) system (K140819). The modifications are to enhance the surgeon's situational awareness during intra-operative use.

510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.

Submitter:

Surgical Theater 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806

Establishment Registration Number: 3010197287

Contact Person:

Kevin M. Murrock Director of Project Management Surgical Theater, LLC 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (330) 472-6520 Fax: (216) 916-3806 Email: kmurrock(@surgicaltheater.net

Date Prepared: May 11, 2016

Name of Device

Trade Name: ●
Other Device Trade Names: ●
Common Name: o
Classification Name: ●
o Regulation Number:
Surgical Navigation Advanced Platform (SNAP) VR SNAP & Endo SNAP System, Image Processing, Radiological Picture Archiving and Communications System 21 CFR 892.2050

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Image /page/4/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver or gray, with a section on the right side colored gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked vertically, written in a serif font with a gold color.

LLZ ● Product Code:
Regulatory Classification: ●
Device Panel: Radiology ●

Predicate Device

Surgical Theater, LLC Surgical Navigation Advanced Platform (SNAP), 510(k) Number: K140819

Device Description:

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Image /page/5/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape that resembles a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font.

Indications for Use:

The SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.

Note: Since the SNAP does not specify a disease, condition (or an anatomical site from which a disease state or population may be inferred), per the FDA Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on July 28, 2014 it has a general "tool type" indications for use resulting in the intended use and indications for use being the same.

Predicate Device Comparison

The modified SNAP is substantially equivalent to the Surgical Navigation Advanced Platform (SNAP), 510(k) Number: K140819.

Characteristic	Predicate: SurgicalNavigation AdvancedPlatform (SNAP)	Modified: SurgicalNavigation AdvancedPlatform (SNAP)	Explanation ofDifferences
510(k) Accession Number	K140819	K160584	NA
Clearance Date	June 27, 2014	TBD	NA
Computer	PC Workstation	PC Workstation	NA
Input Data File Format	DICOM	Same	NA
DICOM Image ModalityTypes Supported	CT and MR	CT, MR and XA	Refer to Note 1below.
Characteristic	Predicate: SurgicalNavigation AdvancedPlatform (SNAP)	Modified: SurgicalNavigation AdvancedPlatform (SNAP)	Explanation ofDifferences
Indications for Use	The SNAP is intended foruse as a software interfaceand image segmentationsystem for the transfer ofimaging information froma CT or MR medicalscanner to an output file. Itis also intended for use insimulating and evaluatingsurgical treatment optionsboth pre-operatively andintra-operatively withvalidated systems asidentified in the devicelabeling.	The SNAP is intended foruse as a software interfaceand image segmentationsystem for the transfer ofimaging information froma CT, MR or X-Ray 3DAngiography (XA)medical scanner to anoutput file. It is alsointended for use insimulating and evaluatingsurgical treatment optionsboth pre-operatively andintra-operatively withvalidated systems asidentified in the devicelabeling.	Refer to Note 2below.
Data Transfer Method	CD or USB	Same	NA
Preoperative Planning	Yes	Same	NA
Patient Contact	No	Same	NA
Human Intervention forInterpretation of Images	Yes	Same	NA
Capability of creating 3Dmodels of patient data from2D scan slices.	Yes	Same	NA
Provides the user withability to input, display,color, and manipulate the2D scan slices via a 3Drepresentation.	Yes	Same	NA
Image tools such asrotation, scaling andcoloring.	Yes	Same	NA
Characteristic	Predicate: SurgicalNavigation AdvancedPlatform (SNAP)	Modified: SurgicalNavigation AdvancedPlatform (SNAP)	Explanation ofDifferences
Capability of connecting toan external SurgicalNavigation system (e.g.Brainlab Kolibri orMedtronic Stealth), andprocessing the incomingnavigation data.	Yes	Same	NA
Intra-operative Use	Yes	Same	NA
Pre-operative Use	Yes	Same	NA
Multiple ImageMerge/Overlay/Alignment	Yes	Same	NA
Software License to ControlSNAP Functionality	Yes	Same	NA
Virtual Reality (VR)Headset Display forPre-Operative Use	No	Yes	Refer to Note 3below.
Virtual Reality (VR)Headset Display forIntra-Operative Use	No	Yes	Refer to Note 4below.
Video Capture PCB tocapture video output from a3rd party endoscopy cameradevice.	No	Yes	Refer to Note 5below.
Endo View screen presentsthe live endoscopy videoside-by-side with the SNAP3D scene.	No	Yes	Refer to Note 6below.

Comparative Analysis

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Image /page/6/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver, with a section on the right side colored gold. Below the ribbon is the text "SURGICAL" in a sans-serif font, stacked above the word "THEATER" in the same font.

Surgical Navigation Advanced Platform (SNAP)

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Surgical Navigation Advanced Platform (SNAP)

Discussion of Differences

The primary differences between the predicate and modified device are as follows:

1. Added input support for X-Ray 3D Angiography (XA) scans. To be usable by the SNAP, the XA scan must be exported by the originating system as a DICOM CT image storage type. During case preparation the SNAP software verifies DICOM data meets the following acceptance criteria; otherwise, data is rejected: 1) Image Modality file type is

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CT, MR or XA and 2) Media Storage SOP Class and SOP Class UID are CT or MR. X-Ray 3D Angiography (XA) modality support was previously implemented in software release 2.5. The determination that the change could not significantly affect safety or effectiveness and a 510(k) premarket submission was not required was documented in the DHF for software release 2.5. The FDA CDRH guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" was referenced in making this determination.

1. The change in the Indications for Use (IFU) of the subject device was due to the addition of the support for X-Ray 3D Angiography (XA) scans as described above in Note 1. While the Indications for Use statement of the subject device is not identical to that of the predicate device, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate device share the same intended use for simulating and evaluating surgical treatment options both pre-operatively and intra-operatively.
1. The addition of the VR headset to display the 3D scene displayed on the LED monitor in a 3D stereoscopic fashion to increase the user's immersion level in the scene was previously implemented in software release 2.6. The determination that the change could not significantly affect safety or effectiveness and a 510(k) premarket submission was not required was documented in the DHF for software release 2.6. The FDA CDRH guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" was referenced in making this determination.
1. Label the Virtual Reality (VR) Headset Display for Intra-Operative Use. Since the VR headset was not included in the EMC testing of the predicate device, the VR headset was labeled for pre-operative use only. Labeling on the VR headset and in the Operator Manual included the statement "Not Intended for OR Use". The EMC testing for the modified device included the VR headset and since no issues were identified, the VR headset will be available for both pre and intra-operative use with labeling updated accordingly.
1. Add a COTS (commercial off-the-shelt) video capture PCB to the desktop PC to capture live video from any 3rd party endoscopy camera device capable of generating HD video output (e.g. Stryker HD 1188 HD Endoscope Camera System or Storz Image 1 HD Camera Head). The captured endoscopy video presented on the SNAP monitor is identical to the video currently presented on the operating room monitors. An advantage of the SNAP's display is that the endoscopy video is presented side-by-side with the SNAP 3D scenes in the new Endo View screen (refer to item 6 below).
1. Add the Endo View GUI and Screen Layout. Updated GUI and screen layout to simultaneously display the synchronized virtual endoscopy camera and live endoscopy camera device views, the 3D scene showing the endoscope device, and virtual / simulated "fly-through" view to provide the surgeon with an enhanced situational awareness during intra-operative use. The Endo View screen presents the live endoscopy video side-by-side with the SNAP 3D scene.

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Image /page/9/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL THEATER" are written in a serif font, with each letter spaced out evenly.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Electromagnetic Compatibility (EMC)

In order to ensure that the use of the SNAP system in the operating room does not adversely affect other devices within the patient environment, EMC evaluation per IEC 60601-1-2:2007 Third Edition was performed by a 3rd party test laboratory on the modified device and the SNAP was found to be in compliance.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff. "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "medium" level of concern, since a malfunction or latent flaw in the software could delay delivery of appropriate medical care that would likely lead to minor injury.

The SNAP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements. A formal verification and validation test plan was executed to confirm that the modified SNAP continues to meet its intended use and performance requirements. The verification and validation report included with this submission summarizes the results of verification and validation activities for the modified device.

Safety and Effectiveness

Product risk management activities were performed in accordance with ISO 14971:2012 throughout the product development process. Risk management verification and validation consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations for the device.

Conclusions

Modifications to the SNAP do not raise new questions of safety and effectiveness.

While the Indications for Use statement of the subject device is not identical to that of the predicate device, the device modifications do not alter the intended use of the device nor do they affect the safety and effectiveness of the device or the fundamental scientific technology relative to the predicate device. Both the subject and predicate devices share the same intended use for simulating and evaluating surgical treatment options both pre-operatively and intra-operatively

Verification and validation results demonstrate the modified SNAP is as safe and effective as the predicate SNAP, and performs as intended in the specified use conditions.

In summary, the SNAP device described in this submission is, in our opinion, substantially equivalent to the 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).