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

Device Description

The purpose of this submission is to update the UNiD Spine Analyzer with the addition of a new software feature: "Data base of implants". This component will allow a user to draw implants (cages, screws and rods) taken from a range of MEDICREA INTERNATIONAL implants, previously cleared in K08009, K083810, K163595, in addition to the design of custom-made implants specific to a unique patient. A catalog of these implants is provided in this submission.

AI/ML Overview

The provided text is a 510(k) summary for the UNiD Spine Analyzer. It states that the submission is to add a new software feature, "Data base of implants," to an already cleared device (UNiD Spine Analyzer, K170172). Therefore, the acceptance criteria and performance data described in this document relate to the new feature and its integration, rather than a full study of the entire device's performance from scratch.

However, the 510(k) summary does not contain specific acceptance criteria tables or detailed performance study results (like sensitivity, specificity, AUC, or other quantitative measures typically found in standalone AI/ML device studies). It primarily focuses on demonstrating substantial equivalence by comparing features and outlining the type of testing performed.

Based on the information provided, here's what can be extracted and what is NOT available:

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

Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., "accuracy > X%"). The document implies acceptance based on successful "verification and validation activities" for the new software feature. For a medical device, this typically means:
- The software correctly performs the functions it's designed for (e.g., implants are drawn accurately, catalog is accessible).
- The new feature doesn't introduce new safety or effectiveness issues.
- The software meets industry standards for medical device software development (e.g., IEC 62304).
Reported Device Performance: No quantitative performance metrics (like accuracy, precision, etc.) are provided for the new "Database of implants" feature. The document only states that "Performance data for the modified UNiD Spine Analyzer consisted of verification and validation activities." and "The addition of the database of implants creates additional tools which were also tested, and documentation was provided."

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

Sample Size: Not specified. The document only mentions "verification and validation activities" for the software feature itself, not a clinical data set for performance evaluation.
Data Provenance: Not specified. Since this is about adding a database of implants and related drawing tools, it's less about analyzing patient image data for diagnosis and more about the software's functional correctness.

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)

Number of experts & Qualifications: Not applicable/not specified. The "ground truth" for this specific submission likely relates to the accuracy of implant representation and placement tools, which would be verified against design specifications, engineering standards, and potentially input from orthopedic surgeons during development, rather than a clinical ground truth established by diagnosing cases.

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

Adjudication Method: Not applicable/not specified.

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

MRMC Study: No, an MRMC study was not described. The device, UNiD Spine Analyzer, assists healthcare professionals in viewing, measuring, and planning orthopedic surgeries. The specific update in this submission is the addition of an implant database. This generally falls under medical image management/measurement software (PACS-like functionality) rather than an AI/ML diagnostic or prognostic tool that would typically undergo MRMC studies. The software is explicitly stated to require "Human Intervention for interpretation and manipulation of images."

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

Standalone Study: Not explicitly described in terms of clinical performance. The "verification and validation activities" confirm the software's functionality, but these are not presented as a standalone clinical performance study typically seen for AI algorithms making diagnostic interpretations. The device is a tool for human use, not an autonomous diagnostic algorithm.

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

Type of Ground Truth: Not specified in the provided text. For a feature involving an implant database and drawing tools, ground truth would likely be based on design specifications, physical accuracy of implant models, and functional correctness according to orthopedic surgical planning principles, rather than clinical outcomes or pathology.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document does not describe the development of a machine learning algorithm that learns from a training set of data. It describes the addition of a database and associated software tools.

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

Training Set Ground Truth Establishment: Not applicable.

Summary of what the document focuses on regarding device acceptance:

The document leverages the concept of "substantial equivalence" to a previously cleared version of the same device (K170172). The acceptance criteria for the new feature (database of implants) are implicit in the statement that "The addition of this new component (i.e., data base of cleared implants) to the UNiD Spine Analyzer does not raise new issues of safety or effectiveness compared to the previously cleared version of the UNiD Spine Analyzer." This implies that the testing (verification and validation) confirmed:

The implant database functions as intended.
The drawing tools work correctly.
The new feature does not adversely affect the safety or performance of the existing cleared functionalities of the UNiD Spine Analyzer.
The software development followed appropriate guidelines for medical device software ("Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices'").

Essentially, for this 510(k) (which is an update to an existing device), the "proof" for acceptance is the demonstration that the change does not negatively impact safety or effectiveness, and the new feature itself is functionally sound, rather than a de novo clinical performance study against specific acceptance criteria.

Summary

{0}------------------------------------------------

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

February 8, 2018

Medicrea International % Mr. David Ryan Chief Operating Officer 5389 Route de Strasbourg-Vancia 69140 Rillieux La Pape FRANCE

Re: K180091

Trade/Device Name: UNiD Spine Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 4, 2018 Received: January 12, 2018

Dear Mr. Ryan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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

{2}------------------------------------------------

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 on last page

510(k) Number (if known)

K180091

Device Name

UNiD Spine Analyzer

Indications for Use (Describe)

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

_ Over-The-Counter Use (21

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) SC Publishing S

Page 1 of 1

{3}------------------------------------------------

510(k) SUMMARY

MEDICREA INTERNATIONAL'S UNiD SPINE ANALYZER

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted to add the UNiD Spine Analyzer.

1. Submitter:

MEDICREA INTERNATIONAL 5389 Route de Strasbourg - Vancia 69140 RILLIEUX LA PAPE FR Phone: +33 (0)4 72 01 87 87 Fax: +33 (0)4 72 01 87 88

Contact Person:

David RYAN MEDICREA INTERNATIONAL 5389 Route de Strasbourg - Vancia 69140 RILLIEUX LA PAPE FR Phone: +33 (0)4 72 01 87 87

Date Prepared: January 04, 2018

1. Trade name: UNiD Spine Analyzer

Classification Name:

Class II, Picture archiving and communications system (21 C.F.R. 892.2050)

Classification and Regulation:

LLZ: system, image processing, radiological

3. Predicate or legally marketed devices which are substantially equivalent:

. UNiD SPINE ANALYZER (MEDICREA INTERNATIONAL, K170172) (primary predicate)
SURGIMAP 2.0 (NEMARIS INC, K141669) (reference device) .

4. Description of the new device

5. Indication for Use

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

{4}------------------------------------------------

6. Substantial equivalence claimed to predicate devices

The table below compares the features and technological characteristics of the cleared UNiD Spine Analyzer to the version with the updated software feature, as well as the reference Surgimap 2.0 device.

Feature	UNiD Spine Analyzer with additional component	UNiD Spine Analyzer ( K170172)	Surgimap 2.0 (K141669)
Computer	PC Compatible	PC Compatible	PC Compatible
Operating System	Windows + MAC	Windows + MAC	Windows + MAC
Image Input	Local	Local	Local + PACS connectivity
Runs on Server	Yes	Yes	No
Osteotomy Module	Yes	Yes	Yes
Generic measurements	Yes	Yes	Yes
Spine measurements	Yes	Yes	Yes
Pre-operative planning	Yes	Yes	Yes
Custom implants	Yes	Yes	Yes
Database	Yes (implants)	No	Yes
Case sharing	No	No	Yes
Human Intervention for interpretation and manipulation of images	Required	Required	Required
Web content	Yes	Yes	Yes

Table 1: Substantial Equivalence Comparison

7. Non-clinical test summary

Performance data for the modified UNiD Spine Analyzer consisted of verification and validation activities. Software verification and validation testing was 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 on Medical Devices". The addition of the database of implants creates additional tools which were also tested, and documentation was provided. The software for this device was considered to be of moderate level of concern.

{5}------------------------------------------------

8. Conclusion

The addition of this new component (i.e., data base of cleared implants) to the UNiD Spine Analyzer does not raise new issues of safety or effectiveness compared to the previously cleared version of the UNiD Spine Analyzer. It is thus substantially equivalent to the company's own legally marketed predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).