spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.

Device Description

spineEOS is a software indicated for assisting healthcare professionals with preoperative planning of spine surgeries. EOS images (generated from EOS imaging's acquisition system) and associated 3D datasets are used as inputs of the software. The product manages clinical measurements and allows user to access surgical planning tools to define a patient specific surgical strategy. The product is indicated for adolescent and adult patients.

AI/ML Overview

The provided document is a 510(k) premarket notification for the device spineEOS. It primarily focuses on demonstrating substantial equivalence to a predicate device (K160407 spineEOS) rather than detailing a clinical study with acceptance criteria and performance data for a novel AI/ML-based device.

Therefore, the document does not contain the detailed information required to fully answer the request, specifically relating to a study proving the device meets acceptance criteria for new or modified AI/ML features. The information regarding performance data (Section 7) states that "Nonclinical performance testing performed on the subject device, spineEOS, supports substantial equivalence to the predicate device" and explicitly, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

However, based on the provided text, I can extract information relevant to the comparison for substantial equivalence as presented, and highlight what is missing for a comprehensive answer on acceptance criteria and a study proving performance for a new AI/ML feature.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for specific performance metrics of a new AI/ML model. Instead, it presents a comparison for substantial equivalence between the modified spineEOS and its predicate (K160407 spineEOS). This comparison focuses on demonstrating that technological differences do not affect safety or effectiveness, not on proving a specific quantitative performance metric against a set acceptance criterion for a novel feature.

Here's a re-interpretation of "acceptance criteria" based on the "Substantially Equivalent?" column in Table 5-1, which represents the justification for equivalence rather than quantitative performance.

Characteristic	Cleared spineEOS (K160407)	Modified spineEOS	Substantially Equivalent? (Implied Acceptance/Justification)	Reported Device Performance
Indications for Use	Using 3D data and models obtained from sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.	spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.	Yes, the modified spineEOS has the same intended use. Slight rephrasing of indications for use does not raise different safety/effectiveness questions.	Not applicable - assessment is on equivalence of stated use.
User Population	Spine surgeons to define and validate the surgical plan.	Spine surgeons and "EOS staff and implant distributors to define and save the optional pre-planning."	Yes, similar. Addition of EOS staff does not affect safety/effectiveness as they have similar account rights and require training.	Not applicable - assessment is on equivalence of user types.
Target Population	Patients 7 years or older who need spine surgery (Degenerative, Deformative adult spine, AIS).	Patients 7 years or older who need spine surgery (Degenerative Spine Surgery, Deformative Spine Surgery, AIS).	Yes, same. Slight rephrasing for consistency doesn't change target population.	Not applicable - assessment is on equivalence of patient types.
Hardware & Software Requirement	Web browsers (Windows: Chrome 47, Firefox 43, Opera 34; Mac: Chrome 47, Firefox 43, Opera 34, Safari 9). PC: Dual Core 2.4 GHz, 4 GB RAM, integrated graphics. Screen: 1920x1080 minimum.	Web browsers (Windows: Chrome, Firefox, Edge; macOS: Chrome, Firefox, Safari). PC: Dual Core 2.4 GHz, 4 GB RAM, integrated graphics. Screen: 1920x1080 minimum.	Yes, similar. Updates account for web browser evolution; minor changes do not affect safety/effectiveness.	Performance not measured against these specs; rather, the capability to run the software.
Tools Available for Planning	Segmental Alignment, Interbody Implant, Osteotomy.	Segmental Alignment, Interbody Implant, Osteotomy, Spondylolisthesis, Rod Curvature Management.	Yes, similar. Fundamental tools unchanged. Introduction of Spondylolisthesis tool (operates on same principle as segmental alignment, just different axis) and Rod Curvature Management does not affect safety/effectiveness.	Functionality of new tools confirmed as per design. No quantitative performance data provided on accuracy or precision of these new tools, only that their introduction does not impact safety/effectiveness because they are based on existing principles.
Image Manipulation Functions	2D/3D display & basic manipulation (zoom, panning, angles measurements).	2D/3D display & basic manipulation (zoom, panning, distance, and angles measurements).	Yes, same. Addition of distance measurement based on same principle as existing angle measurement; does not affect safety/effectiveness.	Functionality tested, no specific quantitative performance reported.

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

The document states "Nonclinical performance testing performed on the subject device, spineEOS, supports substantial equivalence to the predicate device." It also mentions "Validation activities" including "Validation of the multifunctional requirements in terms of design" and "Usability testing".

Sample Size for Test Set: This information is not provided. The document makes no mention of a specific dataset size for evaluating the performance of the claimed features, especially for any new AI/ML components. Given the "nonclinical performance" and "not based on clinical performance data" statements, it's highly likely that a traditional "test set" in the context of an AI/ML study (i.e., a set of patient cases to evaluate algorithm performance) was not part of this 510(k) submission.
Data Provenance: This information is not provided. (e.g., country of origin, retrospective or prospective).

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

This information is not provided. Since the submission states "Determination of substantial equivalence is not based on an assessment of clinical performance data," it's unlikely that such an expert-adjudicated ground truth dataset, typical for AI/ML device evaluations, was used. The focus was on demonstrating that the modified features (like the new Spondylolisthesis tool) function as intended and do not introduce new safety concerns compared to the predicate, rather than on proving diagnostic or measurement accuracy against a gold standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Determination of substantial equivalence is not based on an assessment of clinical performance data." The core of this 510(k) is demonstrating substantial equivalence based on technological comparisons and nonclinical performance (e.g., software verification and validation activities), not an MRMC study.

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

This information is not explicitly provided. The document mentions "Validation of the multifunctional requirements in terms of design" and "Usability testing." The product, spineEOS, is presented as a tool "assisting healthcare professionals," implying a human-in-the-loop model for its primary use ("clinical judgment and experience are required to properly use the software"). There's no separate mention of a "standalone" algorithm-only performance evaluation, especially one related to diagnostic accuracy without human input.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since the submission states it's not based on clinical performance data and focuses on substantial equivalence via nonclinical V&V, the concept of "ground truth" in the context of clinical accuracy (e.g., expert consensus, pathology) for performance claims is not applicable or provided. The "ground truth" for the V&V activities would be the design specifications and requirements.

8. The sample size for the training set

This information is not provided. The document does not describe the specific AI/ML algorithms used or their training. The changes highlighted (like the new Spondylolisthesis tool) are additions to existing functionality, and the filing focuses on their technological equivalence and safety, not on a new AI/ML model requiring a training dataset.

9. How the ground truth for the training set was established

This information is not provided, as there is no mention of a training set for an AI/ML model for this submission.

Summary of what the document does provide regarding performance and validation:

Nonclinical performance testing: This includes design input review, unit testing, software integration, system integration, validation of multifunctional requirements in terms of design, and usability testing.
Safety & Effectiveness Argument: The core argument is that the modified device, including new tools like "Spondylolisthesis" and "Rod Curvature Management," operates on principles similar to existing cleared functionalities (e.g., segmental alignment tool), and therefore does not raise new questions of safety or effectiveness.
No Clinical Performance Data: The submission explicitly states that "Determination of substantial equivalence is not based on an assessment of clinical performance data." This significantly limits the type of "acceptance criteria" and "study" information available, as it implies a focus on V&V of software functionality and comparison to predicate rather than a clinical trial proving new performance claims.

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EOS imaging % Mathilde Masurel Design Quality and Regulatory Affairs Specialist 10 rue Mercoeur Paris, 75011 France

October 24, 2023

Re: K232086

Trade/Device Name: spineEOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 27, 2023 Received: September 27, 2023

Dear Mathilde Masurel:

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, Ph.D. Assistant Director Imaging Software Team 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) K232086

Device Name spineEOS

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 shows the logo for EOS imaging, an "AN cotec COMPANY". The logo is in orange and features the letters "EOS" stacked on top of the word "imaging". The "O" in "EOS" is shaped like a diamond. The words "AN cotec COMPANY" are in a smaller font size and are located below the word "imaging".

1 SUBMITTER

EOS imaging 10 rue Mercoeur Paris, France 75011 Phone: +33 1 55 25 60 60 Fax: +33 1 55 25 60 61

Contact Person:	Mathilde MASUREL
	Design Quality and Regulatory Affairs Specialist
	EOS imaging
Contact Phone:	+33 1 55 25 60 60

Date Summary Prepared: October 23, 2023

2 DEVICE

Trade Name:	spineEOS
Common or Usual Name:	Cloud-based software
Classification Name:	System, image processing, radiological(21 C.F.R. § 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ
Premarket Submission Number:	K232086

LEGALLY MARKETED PREDICATE DEVICES 3

510(k)	Product Name	Clearance Date
K160407	spineEOS	August 2016

DEVICE DESCRIPTION 4

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Image /page/4/Picture/0 description: The image shows the logo for EOS imaging, an orthopedic imaging company. The logo features the letters "EOS" in a stylized, sans-serif font, with the "O" shaped like a diamond. Below the letters "EOS" is the word "imaging" in a smaller, sans-serif font. Underneath "imaging" are the words "AN cctec COMPANY" in an even smaller font, indicating that EOS imaging is a subsidiary of cctec.

INDICATIONS FOR USE 5

TECHNOLOGICAL COMPARISON TO PREDICATES 6

The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantial equivalence, or safety and effectiveness.

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AN alec company

Characteristic	Cleared spineEOS (K160407)	Modified spineEOS	Substantially Equivalent?
Indications for Use	Using 3D data and models obtained from sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.	spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.	Yes, the modified spineEOS has the same intended use as the cleared spineEOS. Specifically, both devices are indicated for assisting healthcare professionals with preoperative planning of spine surgeries.The modified spineEOS has slightly modified indications for use. Specifically, the indications for use statement maintains the basic explanation of the device inputs and available tools.In sum, the same information is provided to the end user; it is simply not organized in the same way. Thus, this change does not raise different questions of safety or effectiveness.
Regulatory Class/Code	Class IILLZ(21 CFR 892.2050)	Class IILLZ(21 CFR 892.2050)	Yes, same.
Device Classification Name	System, image processing, radiological	System, image processing, radiological	Yes, same.
User Population	spineEOS can only be used by a trained user including:Spine surgeons to define and validate the surgical plan.	spineEOS can only be used by a trained user including:Spine surgeons to define and validate the surgical plan.EOS staff and implant distributors to define and save the optional pre-planning.	Yes, similar. The modified spineEOS has EOS staff in addition to the users of cleared spineEOS. This minor change does not affect the safety and effectiveness of the product because EOS staff has the same account right as the implant distributors already considered in the predicate and needs to be properly trained in order to use the product.
Target Population	Patients 7 years or older who need spine surgery. spineEOS is	Patients 7 years or older who need spine surgery. spineEOS is	Yes, same. The modified spineEOS has the same target population as the cleared spineEOS.
Characteristic	Cleared spineEOS (K160407)	Modified spineEOS	Substantially Equivalent?
Hardware andSoftwareRequirement	recommended in the preoperativeplanning of spine surgeries for:• Degenerative surgery• Deformative adult spinesurgery• Adolescent IdiopathicScoliosis (AIS) surgery.	recommended in the preoperativeplanning for spine surgeries for:• Degenerative Spine Surgery• Deformative Spine Surgery• Adolescent Idiopathic Scoliosis(AIS) surgery.	Specifically, both devices are intended for patients 7years or older who need spine surgery.Modified spineEOS has slightly modified targetpopulation statement as compared to the predicate.Specifically, the target population statementmaintains the description of degenerative anddeformative spine surgery for patients 7 years orolder as well as the description of AIS surgery but ina more consistent way.
	Web Browsers:• Windows 7/8.1/10: GoogleChrome 47, Mozilla Firefox43, Opera 34;• For Macintosh OS XYosemite 10.10 et El Capitan10.11: Google Chrome 47,Mozilla Firefox 43, Opera 34et Safari 9.PC Configuration:Stable internet connection - DualCore 2.4 GHz processor, 4 GB ofRAM and integrated graphicsboard.Screen Resolution:The minimum screen resolutionensuring full display of the	Web Browsers:• Windows 10/11: GoogleChrome, Mozilla Firefox, Edge• For macOS 12/13: GoogleChrome, Mozilla Firefox, SafariPC Configuration:Stable internet connection - Dual Core2.4 GHz processor, 4 GB of RAM andintegrated graphics board.Screen Resolution:The minimum screen resolutionensuring full display of the planningpage is 1920 x 1080 pixels.At resolutions below 1600 x 900, theapplication prompts the user to toggle	In sum, the same information is provided to the enduser; it is simply stated differently. Thus, this minorchange does not raise different questions of safetyor effectiveness.Yes, similar. The differences between modifiedspineEOS and the predicate take into account theevolution of the web browsers. These minorchanges do not affect the safety and effectivenessof the product.
Characteristic	Cleared spineEOS (K160407)	Modified spineEOS	Substantially Equivalent?
	planning page is 1920 x 1080 pixels.At resolutions below 1600 x 900, the application prompts the user to toggle to full screen display to ensure correct visualization.	to full screen display to ensure correct visualization.
Input Data	Patient's information X-rays images 3D model of the spine	Patient's information X-rays images 3D model of the spine	Yes, same.
ProductWorkflow	Model Validation: allow users to validate or reject the 3D modeling.Preoperative: allow user to consult the preoperative state of the patientPlanning: allow user to define patient specific surgical strategyRod: allow user to define the design of rods	Model Validation: allow users to validate or reject the 3D modeling.Preoperative: allow user to consult the preoperative state of the patientPlanning: allow user to define patient specific surgical strategyRod: allow user to define the design of rods	Yes, same.
Tools Availablefor Planning	Segmental Alignment Interbody Implant Osteotomy	Segmental Alignment Interbody Implant Osteotomy Spondylolisthesis Rod Curvature Management	Yes, similar. Modified spineEOS is an updated version of the cleared spineEOS. The fundamental tools of modified spineEOS are unchanged from the cleared spineEOS. Both devices have tools for segmental alignment, interbody implant, and osteotomy.Modified spineEOS main difference from the cleared spineEOS is the introduction of the spondylolisthesis tool. This tool operates on the same principle than the existing segmental alignment tool, except that it allows movement of the vertebra on a different axis (translation for the spondylolisthesis tool vs. rotation for the segmental
Characteristic	Cleared spineEOS (K160407)	Modified spineEOS	Substantially Equivalent?
SoftwareFunctionalities /Modalities	Obtains an image and 3D modeltransferred from other devicesProvides normative values usedto follow the impact of theplanning on the patient alignmentProvides color-coded clinicalparameters to display variancefrom the defined normative valuesRequires human intervention forinterpretation and manipulation ofimages	Obtains an image and 3D modeltransferred from other devicesProvides normative values used tofollow the impact of the planning onthe patient alignmentProvides color-coded clinicalparameters to display variance fromthe defined normative valuesRequires human intervention forinterpretation and manipulation ofimages	alignment tool) and the possibility to manage the rodcurvature.The introduction of this tool does not affect thedevice safety and effectiveness.Yes, same.Yes, same.Yes, same.Yes, same.
ImageManipulationFunctions	2D images and 3D model displayand basic manipulation (zoom,panning and anglesmeasurements)	2D images and 3D model display andbasic manipulation (zoom, panning,distance, and angles measurements)	Yes, same. In modified spineEOS, the possibility ofmeasuring distance directly in the image is based onthe same principle as the measurement of angles,already available in the cleared spineEOS. It doesnot affect the device safety and effectiveness.Yes, same.
MeasurementFunctions	Distances and Angles	Distances and Angles	Yes, same.
User Interface	Computer	Computer	Yes, same.
SoftwareEnvironment	Cloud-based software	Cloud-based software	Yes, same.

Table 5-1: Comparison for Substantial Equivalence

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Traditional 510(k) Premarket Notification

ಲ್ಲಿ ಪ್ರದ

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Image /page/7/Picture/0 description: The image shows the logo for EOS imaging, an aztec company. The logo is vertically oriented, with the letters "EOS" stacked on top of each other in a sans-serif font. The word "imaging" is written to the right of the letters "EOS", and the phrase "an aztec company" is written below the word "imaging". The logo is orange in color.

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Image /page/8/Picture/0 description: The image shows the logo for EOS imaging, an aztec company. The logo is vertically oriented, with the letters "EOS" stacked on top of each other in an orange, outlined font. To the right of the letters, the word "imaging" is written vertically in a smaller font. Below "imaging" is the phrase "AN aztec COMPANY" in an even smaller font.

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Image /page/9/Picture/0 description: The image shows the logo for EOS imaging, an orthopedic imaging company. The logo is in orange and features the company name in a stylized font. Below the name, it says "AN cdetec COMPANY" in a smaller font. The logo is simple and modern, and the orange color is eye-catching.

PERFORMANCE DATA 7

Nonclinical performance testing performed on the subject device, spineEOS, supports substantial equivalence to the predicate device. The following V&V testing was performed:

A. Verifications activities cover the following:

o Design input review
Unit testing ●
Software integration 0
o System integration
B. Validation activities cover the following:
- Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that spineEOS can be used safely . by assessing and mitigating usability risks.
- Validation of the clinical parameters o

Determination of substantial equivalence is not based on an assessment of clinical performance data.

CONCLUSION 00

Based upon the information provided in this 510(k) submission, it has been determined that the subject device, spineEOS, is substantially equivalent to the legally marketed predicate device in regard to indications for use, intended use, design, technology, and performance.

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).