The KBA3D v2.0.0 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.

The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bending algorithm is intended for patients older than 22 years old.

Device Description

The subject device KBA3D v2.0.0 is a SaaS software solution developed by S.M.A.I.O for the medical community; it is a second, independent version of the original KBA3D cleared by FDA in K213975. The current version of the KBA3D software is v.2.0.0. The user needs and requirements of the subject device were jointly defined by S.M.A.I.O and NuVasive. The software is intended to view images, perform spine related measurements, and plan surgical procedures such as osteotomies of the spine and templating of implants (screws, cages, rods).

KBA3D V2.0.0 software can be used by health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies. The KBA3D V2.0.0 software is intended for patients requiring measurements and planning of surgical procedures. KBA3D v2.0.0 aims to achieve three objectives:

1. From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
1. Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
1. Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.

The software is not intended to predict the results of surgery as S.M.A.I.O does not provide tools to carry out planning. Therefore, regarding implant sizing, positioning, and correction impacts, accuracy levels provided by S.M.A.I.O are solely based on theoretical calculations that are not correlated to the output of surgery. KBA3D V2.0.0 provides scaled and simplified representations of the screws and cages relative to the patient's spine and pelvis.

Bendini service (part of NuVasive Pulse System, K210574, reference device):

The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.

Note: The Bendini Rod Bending algorithm is intended for patients older than 22 years old. The NuVasive Bendini Web App service is comprised of an API REST web service that facilities outside clients to utilize the NuVasive Bending algorithm. This algorithm is identical to the Bendini algorithm in K210574 for the NuVasive Pulse System and is hosted using the Microsoft Azure App Service. The KEOPS database manages connection to the software, patient data, and storage of data (X-rays and simulations).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KBA3D v2.0.0 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Measurement	Acceptance Criterion	Reported Device Performance
3D Algorithm Reconstruction (Vertebral Body Dimensions from 2D Images vs. CT-Scan)	Max deviation < 5mm	Max average deviation was 4.3mm (most deviations < 3mm)
Uncertainty Testing (Distance Deviation)	< 2 pixels (px)	Acceptable variations (specific value not given, but stated as "acceptable")
Uncertainty Testing (Angular Deviation)	< 2°	Acceptable variations (specific value not given, but stated as "acceptable")
Surgical Simulation (Spino-Pelvic Alignment, SSA error)	Not explicitly stated, but implies high similarity to post-op	Highest SSA error was 3.26%, back types obtained by simulation identical to post-op version
Screw Positioning (Entry Point Deviation)	< 0.5 mm	< 10-12 mm (This seems to be a typo in the document as it's much larger than the acceptance criterion. Assuming it should be <0.5mm, or the criterion is misstated.)
Screw Positioning (Angulation Deviation)	< 0.5°	< 0.3°
Cage Positioning (Height Offset)	< 0.5 mm	< 0.4mm
Cage Positioning (Angulation Deviation)	< 0.5°	< 10-12° (This also appears to be a typo in the document. Assuming it should be <0.5°, or the criterion is misstated.)
Anatomical Parameters Measurements (compared to Excel calculations)	No difference in calculations	No difference in calculations
Formative and Summative Studies (Safety & Usability)	Intuitive use, successful performance	Intuitive use confirmed, users successfully performed measurements and 3D reconstruction that simulated surgery

Important Note Regarding Typos: The reported performance for "Screw Positioning (Entry Point Deviation)" and "Cage Positioning (Angulation Deviation)" (< 10-12 mm and < 10-12° respectively) appears to conflict significantly with the acceptance criteria (< 0.5 mm and < 0.5°). It is highly probable these are typos in the provided document and likely intended to report performance within the acceptance criteria (e.g., < 0.01-0.02 mm or similar for the screws and cages). For accurate reporting, clarification from the original submission would be needed.

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

3D algorithm reconstruction: Not explicitly stated, but refers to "Vertebral body dimensions... from CT-Scan."
Surgical Simulation: 12 patients (for comparison with post-op images).
Other tests (anatomical measurements, uncertainty, screw/cage positioning): Sample sizes are not explicitly provided in the document.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

Surgical Simulation: "by a spine surgeon." The exact number (implied one or more), and detailed qualifications are not specified beyond "spine surgeon."
Other tests: The document does not explicitly state the number or qualifications of experts used for establishing ground truth for other tests.

4. Adjudication Method

The document does not explicitly describe an adjudication method (like 2+1, 3+1). For the surgical simulation, it mentions comparison "by a spine surgeon," implying assessment by an expert.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is not mentioned or described in the provided text. The device is referred to as "assisting healthcare professionals," but no study on the effectiveness of this assistance on human reader performance is detailed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance assessment of the algorithm was conducted for various parameters:

Anatomical parameters measurements: Verified via mathematical calculations (Excel vs. KBA3D v2.0.0).
3D algorithm reconstruction: Verified by comparison of Vertebral body dimensions from 3D reconstructions using the Balance Analyzer and 3D reconstructions from CT-Scan.
Uncertainty testing studies: Comparing original coordinates and "worst case variation" coordinates.
Performance of the algorithm to position the screws: Verified.
Performance of the algorithm to position the cage: Verified.

7. Type of Ground Truth Used

Anatomical parameters measurements: Mathematical calculations (Excel).
3D algorithm reconstruction: 3D reconstructions from CT-Scan.
Surgical Simulation: Post-treatment radiographs (post-op images) and assessment by a spine surgeon.
Screw & Cage Positioning: Theoretical calculations/references (implied by "performance of the algorithm to position the screws/cage was verified").

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

S.M.A.I.O. % Robert Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, Quebec J7W3J6 CANADA

Re: K223841

May 30, 2023

Trade/Device Name: KBA3D v2.0.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2023 Received: May 2, 2023

Dear Dr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K223841

Device Name KBA3D v2.0.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K223841

510(k) SUMMARY for K223841

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of S.M.A.I.O's KBA3D V2.0.0 software.

A. SUBMITTERS INFORMATION Submitter Name:

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-de-L'Ile-Perrot, Québec, J7W 3J6, CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Fax Number:	514-901-0796
Date of Submission:	May 2, 2023

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	S.M.A.I.O
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:	KBA3D v2.0.0
Device Common Name:	Image measurement and surgery planningsoftware
Classification Name:	Picture archiving and communicationssystem
Classification Code:	LLZ
Classification Panel:	Radiology Devices
Regulation Number:	21 CFR sections 892.2050
C1. PRIMARY PREDICATE DEVICEK213975	KEOPS Balance Analyzer 3D (KBA3D)
C2. PREDICATE DEVICES
K180091	UNiD Spine Analyzer, Medicrea International
K141669	Nemaris Surgimap 2.0
C3. REFERENCE DEVICE
K210574	NuVasive Pulse System

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D. DEVICE DESCRIPTION

1. From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
1. Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
1. Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.

Bendini service (part of NuVasive Pulse System, K210574, reference device):

The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.

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E. INTENDED USE

The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bendini Rod Bending algorithm is intended for patients older than 22 years old.

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The table below compares the technological characteristics of the KBA3D V2.0.0 to the predicate and reference devices.

	Subject Device	Predicate Device(Primary)	PredicateDevice	PredicateDevice	ReferenceDevice
Feature	KBA3D V2.0.0K223841	KEOPS BalanceAnalyzer 3DK213975	NemarisSurgimap 2.0K141669	MedicreaUNiD AnalyzerK180091	NuVasive PulseSystemK210574
Computer	PC Compatible	PC Compatible	PC Compatible	PC Compatible	PC Compatible
Operating System	Windows + MAC	Windows + MAC	Windows + MAC	Windows + MAC	Windows
Image Input	Local	Local	Local + PACSconnectivity	Local	Local
Runs on Server	Yes	Yes	No	Yes	No
Osteotomy Module	Yes	Yes	Yes	Yes	No
Spine measurements	Yes	Yes	Yes	Yes	Yes
Pre-op planning	Yes	Yes	Yes	Yes	No
Screws	Yes	No	No	Yes	Yes
Cages	Yes	No	Yes	No	No
Rods	Yes	Yes	Yes	Yes	Yes (Bendini)
Database	No	No	Yes	No	No
Case sharing	No	No	Yes	No	No
Human intervention for image interpretation and manipulation	Yes	Yes	Yes	Yes	Yes

G. PERFORMANCE SUMMARY

The performance characteristics of the KBA3D V2.0.0 were tested and analyzed per the FDA's quidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA quidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The pre-clinical tests and results for the subject device included:

· Anatomical parameters measurements were verified via mathematical calculations. The values were compared to the parameters calculated by the KBA3D V2.0.0 software. The results showed

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there was no difference in the calculations by Excel and KBA3D V2.0.0 software.

· 3D algorithm reconstruction on 2D Images were verified by comparison of Vertebral body dimensions from: (1) 3D reconstructions using the Balance Analyzer and 3D reconstructions from CT-Scan. The results showed that most of the deviations were less than 3mm and that the average was a maximum of 4.3mm (less than the maximum validation criterion of 5mm).
· Uncertainty testing studies comparing original coordinates and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software. A deviation in distance of less than 2 pixels (px) and a deviation of not more than 2° were considered acceptable.
Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm in comparison with images (postop, 12 patients) by a spine surgeon. The highest value of the SSA error was 3.26% and the set of back types obtained by simulation was identical to the post-op version.
· Performance of the algorithm to position the screws was verified. A deviation < 10-12 mm was observed for the positioning of the entry point of the screws (less than the acceptance criterion of 0.5 mm) and a deviation < 0.3° was observed for the angulation of each screw in the vertebra ((less than the acceptance criterion of 0.5°)
· Performance of the algorithm to position the cage was verified. A deviation < 0.4mm offset was observed between the height of the café and the disc space (less than the acceptance criterion of 0.5 mm) and a deviation < 10-12° was observed for the angulation between the two vertebrae and the angulation given by the cage (less than the acceptance criterion of 0.5°)
· Formative and summative studies demonstrated the safety and usability intuitiveness of the KBA3D V2.0.0 software. Intuitive use was confirmed and the users successfully performed measurements and 3D reconstruction that simulated surgery.

Software validation and performance testing of the KBA3D V2.0.0 consisted of verification and validation activities using the following guidelines and standards throughout the software development process:

EN ISO 14971:2019	Application of risk management to medical devices
IEC 62304:2006	Medical device software - Software life cycle processes
EN 62366-1:2015/A1:2020	Medical Device Part I – Application of the UsabilityEngineering to Medical Devices
IEC 82304-1:2016	Health Software – Part I General Requirements ForProducts Safety
FDA Guidance for Industryand FDA Staff	Guidance for the content of premarket submissions forsoftware contained in medical devices (May 11, 2005)

The software for the KBA3D V2.0.0 is of Moderate level of concern.

H. CONCLUSIONS

The KBA3D v2.0.0 is substantially equivalent to the primary predicate device KEOPS Balance Analyzer 3D (K213975) which we relied upon in determining substantial equivalence for the subject device for 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).