Using 3D data and models obtained with 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.

Device Description

spineEOS 1.0 allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. The images displayed are x-rays from EOS System (K152788) and 3D model of the spine from sterEOS Workstation (K141137). spineEOS also displays preoperative parameters compared with reference values and updated values of parameters after planning. spineEOS is accessible on any computer via ONEFIT Management System (Class I device - Product code LMD - 510(k) Exempt) that provides a secure interface and storage through authentication mechanisms.

AI/ML Overview

The FDA 510(k) summary for spineEOS provides some information regarding its performance data, but it does not contain a detailed study with acceptance criteria, specific reported device performance metrics, sample sizes, or information about experts and ground truth as requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (Surgimap 2.0) by comparing intended use, indications, and technological characteristics.

Here's an analysis of what is available and what is missing from the provided text, structured according to your request:

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

Missing from the document. The document states: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." However, specific acceptance criteria or detailed results of these tests (e.g., accuracy of measurements, success rate of planning tools) are not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing from the document. The summary mentions "Software verification and validation testing," but does not specify the sample size of any test set or the provenance of the data used for such testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing from the document. There is no mention of experts, ground truth establishment, or their qualifications for any validation testing.

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

Missing from the document. No information about adjudication methods for a test set is 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

Missing from the document. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to the predicate device's existing functionality rather than quantifying human performance improvements.

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

Implied, but not detailed. The "Software verification and validation testing" would typically involve standalone performance testing of the algorithms and software functionalities. However, the specifics of these tests and their results are not detailed. The spineEOS is described as "assisting healthcare professionals," implying it's a human-in-the-loop device, but standalone testing of its components would be part of standard V&V. Again, no specific results are provided.

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

Missing from the document. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set

N/A (or not explicitly stated as a "training set"). The spineEOS is a software for viewing, measuring, and planning based on existing 3D data and models (from sterEOS workstation). It's not described as a machine learning device that requires a distinct "training set" in the sense of a deep learning model. Its validation would focus on the accuracy of its measurements and the functionality of its planning tools against known standards or expert opinion, not on learning from a dataset.

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

N/A. Since a classical machine learning "training set" is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable in that context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

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

April 8, 2016

ONEFIT medical, Inc. % Mr. Julien Simon QA/RA Manager 18 rue Alain Savary Besancon, 25000 FRANCE

Re: K160407

Trade/Device Name: spineEOS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 12, 2016 Received: February 16, 2016

Dear Mr. Simon:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160407

Device Name spineEOS

Indications for Use (Describe)

Using 3D data and models obtained with sterEOS workstation, spineEOS software is indicated for assisting healtheare 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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FORM FDA 3881 (8/14)

Page 1 of 1

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510(k) SUMMARY ONEFIT's spineEOS

Submitter

ONEFIT medical, Inc.

18, rue Alain Savary 25000 Besancon France

Phone: +33(0) 3 81 25 24 27 Fax: +33(0) 3 81 25 53 51

Contact Person: Mr Julien SIMON, QA/RA Manager Date Prepared: February 11, 2016

Device

Name of Device: spineEOS Classification Name: Picture Archiving and Communication System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

Predicate Device

Surgimap 2.0 (K141669) by Nemaris Inc.

Intended Use/Indications for Use

Device Description

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Comparison of Technological Characteristics with the predicate device

Preoperative planning for spine surgery is the technological principle for both spineEOS and its predicate. The aim for these software is to provide to the surgeon realistic tools for simulating the correction of the curves of the spine.

spineEOS 1.0 (ONEFIT medical, Inc.) and its predicate Surgimap 2.0 (Nemaris, Inc.) are based on the same following technological elements:

Access to the software is secured and limited only to surgeons because personal data are stored in those software and surgical experience is required.
Use of x-ray images and preoperative calculated parameters from the patient's anatomy.
Use of the workflow to guide the surgeon through the steps of planning: observation, analysis and action.
An interface that allows for the maximum amount of information (including images) and tools, visible simultaneously on the same page.
Tools for improve visualization, to perform angle measurements, to position cages, osteotomies and to adjust the curvature of the spine.
Display values of preoperative parameters and updated values after planning.

The only differences between spineEOS and its predicate are:

(1) spineEOS claims compliance with the standard IEC 62366-1:2015.

(2) spineEOS is available online.

(3) Software and hardware minimum requirements for spineEOS.

(4) spineEOS allows to export a planning report.

(5) X-rays for spineEOS are already calibrated.

(6) spineEOS input data comprise a 3D model of the spine.

These differences do not present any new questions of safety or effectiveness because:

(1) This standard is about the application of the concept of usability for medical devices interface. This standard helps the manufacturer to take into account the dangers associated with the interface and reduce the risks associated with the use as far as possible.

(2) Data storage and transfers are secured with currently available technologies. Moreover, ONEFIT can ensure that all users have access to the latest version of software by managing updates and the availability. This feature is also encountered in the ONEFIT Hip Planner (K142671).

(3) These requirements are not disproportionate to the computers currently on the market.

(4) All the information contained in this report can be found in the software, which is equivalent to the consult of a saved planning in Surgimap. The generation of a planning report is also an available feature in the ONEFIT Hip Planner (K142671).

(5) X-rays come from EOS System (K152788) and data for calibration are recorded during the acquisition of the images to calibrate them automatically. spineEOS only import the output data unchanged. The risk of human error regarding the calibration images is thus rejected.

(6) This 3D model reconstruction is performed by sterEOS Workstation (K141137), which is a medical device already cleared by the FDA. All indications of use and operating procedures of sterEOS Workstation are respected. spineEOS only import the output data unchanged.

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spineEOS has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the spineEOS and its predicate device raise no new issues of safety or effectiveness.

Performance Data

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator, or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Conclusions

The device has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate device. The minor differences between the device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the spineEOS is as safe and effective as its predicate Surgimap 2.0 (K141669) and, thus, is substantially equivalent.

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).