The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Device Description

The KEOPS Balance Analyzer 3D (KBA3D) is a software solution developed for the medical community. It is intended to view images and perform spine related measurements and plan surgical procedures. The image formats supported include standards such as jpeg, tiff, png, and DICOM file types. Images can be stored in the KEOPS database and measurements made using generic measuring and surgical tools within overlays of the images. The KEOPS Balance Analyzer 3D offers the ability to plan spine surgical procedures such as ostectomies of the spine and templating implants (rods). Keops Balance Analyzer 3D is web-based software.

AI/ML Overview

The provided text describes specific performance tests and acceptance criteria for the KEOPS Balance Analyzer 3D (KBA3D) software, which is intended for assisting healthcare professionals in viewing, measuring, and planning spine surgeries.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text, structured according to your requested points:

Acceptance Criteria and Device Performance Study for KEOPS Balance Analyzer 3D

The KEOPS Balance Analyzer 3D (KBA3D) underwent non-clinical performance testing to demonstrate its accuracy, precision, and reliability in various functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

Functionality Tested	Acceptance Criteria	Reported Device Performance
Anatomical Parameters Measurement	Acceptable variations of values between original and "worst case variation" coordinates.	"Comparison of original and 'worst case variation' coordinates demonstrated acceptable variations of values and validated the accuracy of the software in measuring anatomical parameters."
Data Point Acquisition Repeatability/Reliability	Barycenter location within 3 pixels (or less).	"Data point acquisition was determined to be repeatable and reliable based on measurements showing location of the barycenter to be within the acceptance criteria of 3 pixels (or less)."
Spino-Pelvic Parameters Calculation	No difference in results compared to manual MS Excel calculations.	"Calculation of spino-pelvic parameters showed no difference in results between the KBA3D software and manual calculations using MS Excel."
Surgical Planning & Simulation Reliability	Planned corrections by the software compared to actual post-operative radiographic images met acceptance criteria.	"The reliability of the KBA3D surgical planning and simulation algorithm was demonstrated by comparing the planned corrections by the software to the actual corrections obtained from postoperative radiographic images. The acceptance criteria were met."
2D3D Reconstruction Accuracy	Allowable maximum deviation of 5mm (which is 10% of the average dimension of a vertebral body) between 3D models from CT scans and 3D reconstructions from X-ray images.	"The reliability of KBA3D 2D3D reconstruction algorithm was validated by comparing 3D models from CT scans to 3D reconstructions from the KBA3D software from X-ray images; the results met the acceptance criteria of an allowable maximum deviation of 5mm (which is 10% of the average dimension of a vertebral body)."
Software Usability	No measurable, clinically relevant differences between user groups (first-time users vs. implied experienced users/benchmark).	"The usability of the software was validated for the process of acquisition and intuitiveness of use by orthopaedic spine surgeons using the software for the first time. The results showed no measurable, clinically relevant differences between the user groups."

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

The document does not explicitly state the specific sample sizes for each of the performance tests. However, it mentions:

For Usability Study: "A study was conducted with fifteen spine surgeons to validate the usability of the KBA3D software." This indicates a test set of 15 users.
For 2D3D Reconstruction: Comparison was done between "3D models from CT scans to 3D reconstructions from the KBA3D software from X-ray images." This implies a dataset of both CT and X-ray images.
For Surgical Simulation: Comparison of "planned corrections by the software to the actual corrections obtained from postoperative radiographic images." This implies a dataset of pre-operative (for planning) and post-operative images.

Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It describes the data as "2D Images (Profile and Face)" and "postoperative radiographic images" for the reconstruction and simulation tests respectively, and general "images" for measurement.

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

For Usability Study: "fifteen spine surgeons" were used. Their specific qualifications (e.g., years of experience) are not detailed beyond "orthopaedic spine surgeons." These individuals were the "users" of the software, testing its intuitiveness and acquisition process, rather than primarily establishing ground truth for the technical performance metrics.
For Technical Performance Ground Truth:
- Anatomical Measurements and Spino-Pelvic Parameters: Ground truth appears to be established through "mathematical calculations" and "manual calculations using MS Excel," implying established analytical methods rather than expert consensus on images.
- 2D3D Reconstruction: Ground truth was "3D models from CT scans." This suggests that high-fidelity CT data served as the reference for evaluating the accuracy of 3D reconstruction from 2D X-rays. While experts might have reviewed these, the ground truth source itself is described as the CT data.
- Surgical Simulation: Ground truth was "actual corrections obtained from postoperative radiographic images." This represents real-world outcomes data which is then compared against the software's predicted outcomes.

The document does not specify the number of experts (e.g., radiologists, orthopedic surgeons) used solely to establish ground truth for the image-based measurements or reconstructions, nor their detailed qualifications, other than the 15 spine surgeons for the usability study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test data. The ground truth appears to be derived from objective calculations (mathematical, Excel), reference imaging (CT scans), or real-world post-operative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how human readers improve with AI vs. without AI assistance, was not explicitly described for the KBA3D's clinical effectiveness as an AI assistance tool. The usability study involved human users (15 spine surgeons) but focused on the software's intuitiveness and acquisition process, not a direct comparison of diagnostic or planning accuracy with and without AI assistance. The performance testing focuses on the software's inherent accuracy and reliability.

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

Yes, the performance characteristics described, such as "Anatomical parameters measurements were verified via mathematical calculations," "3D algorithm reconstruction on 2D Images were verified by comparing vertebral body dimensions," and "Accuracy and precision testing were conducted," largely describe the standalone performance of the algorithm. While the device is intended to assist human users, the validation of its core functionalities (measurements, reconstructions, calculations) appears to be done algorithmically against established ground truths or comparative data, essentially demonstrating the algorithm's performance independent of a human-in-the-loop comparison.

7. The Type of Ground Truth Used

The types of ground truth used include:

Mathematical Calculations: For anatomical parameters and spino-pelvic parameters.
CT Scan Data: For validating 3D reconstruction from 2D X-ray images. This serves as a higher-fidelity reference.
Outcomes Data: "actual corrections obtained from postoperative radiographic images" for validating surgical simulation.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set of the KEOPS Balance Analyzer 3D. The focus of this 510(k) summary is on the testing and validation of the device's performance, not its development or training phase.

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

Since the training set size is not mentioned, the method for establishing its ground truth is also not described in this document.

Summary

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S.M.A.I.O % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de Llle Perrot, Quebec J7V7P2 CANADA

Re: K213975

May 6, 2022

Trade/Device Name: KEOPS Balance Analyzer 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 1, 2022 Received: April 5, 2022

Dear Robert Poggie:

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 and Part 809 ); medical device reporting (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 DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K213975

Device Name KEOPS Balance Analyzer 3D

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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510(k) SUMMARY for K213975

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, NDIP, Québec, J7V 7P2, CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Fax Number:	514-901-0796
Date of Submission:	May 3, 2022
B. DEVICE IDENTIFICATION & MANUFACTURER
Manufacturer Name:	S.Μ.Α.Ι.Ο.
Manufacturer Address:	2, Place Berthe Morisot - Parc Technologique69800 SAINT-PRIEST - France
Registration Number:	3015383864
Contact Name:	Jean-Charles Roussouly
Title:	Operations Vice-President
Device Trade Name:	KEOPS Balance Analyzer 3D (KBA3D)
Device Common Name:	Image measurement and surgery planning software
Classification Name:	Picture archiving and communications system
Classification Code:	LLZ
Classification Panel:	Radiology Devices
Regulation Number:	21 CFR sections 892.2050

C1. PRIMARY PREDICATE DEVICE
K141669	SURGIMAP, NEMARIS INC
C2. PREDICATE DEVICE
K180091	UNID Spine Analyzer, Medicrea International

D. DEVICE DESCRIPTION

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E. INDICATIONS FOR USE

The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Feature	Keops BalanceAnalyzer 3D (KBA3D)	Nemaris Surgimap 2.0	MedicreaUNiD Spine Analyzer
	K # TBD	K141669	K180091
Computer	PC Compatible	PC Compatible	PC Compatible
Operating System	Windows + MAC	Windows + MAC	Windows + MAC
Image Input	Local	Local + PACS connectivity	Local
Runs on Server	Yes	No	Yes
Osteotomy Module	Yes	Yes	Yes
Spine measurements	Yes	Yes	Yes
Pre-operative planning	Yes	Yes	Yes
Database	No	Yes	No
Case sharing	No	Yes	No
Human Intervention forinterpretation andmanipulation of images	Yes	Yes	Yes
Web content	Yes	Yes	Yes

The table below compares the technological characteristics of the KEOPS Balance Analyzer 3D subject device to the Nemaris and Medicrea predicate devices

The subject and predicate devices possess similar or the same technological, performance, and userinterface characteristics that are intended to aid health care professionals in the pre-operative planning of spine surgery. The minor differences in features present no new risks. The similarity of the technological features indicates the subject and predicate devices are substantially equivalent.

G. PERFORMANCE SUMMARY

The performance characteristics of the Keops Balance Analyzer 3D were tested and analyzed per the FDA's guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

The non-clinical tests performed with the subject included:

Anatomical parameters measurements were verified via mathematical calculations.

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. 3D algorithm reconstruction on 2D Images (Profile and Face) were verified by comparing vertebral body dimensions from the features 'Balance Analyzer 3D reconstruction' and '3D reconstruction CT-Scan'.
Accuracy and precision testing were conducted to demonstrate the performance of the software.
. Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm with comparison post operative images.
. A study was conducted with fifteen spine surgeons to validate the usability of the KBA3D software.

The results of the non-clinical performance testing showed:

. Comparison of original and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software in measuring anatomical parameters.
. Data point acquisition was determined to be repeatable and reliable based on measurements showing location of the barycenter to be within the acceptance criteria of 3 pixels (or less).
. Calculation of spino-pelvic parameters showed no difference in results between the KBA3D software and manual calculations using MS Excel.
. The reliability of the KBA3D surgical planning and simulation algorithm was demonstrated by comparing the planned corrections by the software to the actual corrections obtained from postoperative radiographic images. The acceptance criteria were met.
. The reliability of KBA3D 2D3D reconstruction algorithm was validated by comparing 3D models from CT scans to 3D reconstructions from the KBA3D software from X-ray images; the results met the acceptance criteria of an allowable maximum deviation of 5mm (which is 10% of the average dimension of a vertebral body).
. The usability of the software was validated for the process of acquisition and intuitiveness of use by orthopaedic spine surgeons using the software for the first time. The results showed no measurable, clinically relevant differences between the user groups.

In addition, Software validation and performance testing of the KEOPS Balance Analyzer 3D consisted of verification and validation activities using the following guidelines and standards throughout the software development process:

EN ISO 14971	Application of risk management to medical devices
IEC 62304	Medical device software - Software life cycle processes
ANSI/IEEE Standard 829-2008	IEEE Standard for Software and System Test Documentation
FDA Guidance for Industry andFDA Staff	Guidance for the content of premarket submissions for softwarecontained in medical devices (May 11, 2005)

The software for the KEOPS Balance Analyzer 3D is of moderate level of concern.

H. CONCLUSIONS

The KEOPS Balance Analyzer 3D is substantially equivalent to the identified predicate devices based on similarities in indications for use, design, technological characteristics, performance data, and user interface presented in this 510(k) notification.

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).