E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Device Description

e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.

The subject submission seeks to add humeral planning capabilities to the previously cleared FH E-Ortho Shoulder Software. Additional changes to the software have been made to improve functionality within the previously cleared intended use.

AI/ML Overview

The e-Ortho Shoulder Software v1.1 is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement. The performance testing for this device is primarily focused on verification and validation activities, and a comparison against a "gold standard" software.

Here's a breakdown of the requested information based on the provided document:

Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out acceptance criteria in a quantitative table with corresponding device performance metrics like sensitivity, specificity, or AUC as might be seen for diagnostic AI. Instead, the acceptance is demonstrated through the successful completion of verification and validation processes and equivalence to a "gold standard" software.

Acceptance Criterion Type	Description	Reported Device Performance
Functional Verification	Verification of functional components of the subject device through test campaigns.	Five test campaigns carried out by five different evaluators in two different environments. Three minor bugs identified, but "not expected to impact the planning itself."
Usability Validation	Validation of critical features through usability testing.	A usability test campaign conducted with five surgeons. "The result of the validation tests coincides with the expected results for each test case and no test failed."
Accuracy Testing	Comparison of implant values (version and inclination) obtained from the subject device against a "gold standard" software in simulated dangerous situations and potential harms.	Simulations included right and left-sided scenarios, head-first/feet-first supine positioning, varying reaming depths, and implant visualization from varying angles. Compared to Materialise Innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. "All tests passed." "Thus, the accuracy of e-Ortho is adequate to provide safe use of the product."

Sample size used for the test set and the data provenance:
- Functional Verification Test Set: The sample size is not explicitly stated in terms of patient cases or images. Instead, it refers to "five test campaigns" carried out by "five different evaluators in two different environments" to verify "functional components." This suggests a focus on software functionality testing rather than patient data performance.
- Usability Validation Test Set: "Usability test campaign, with critical features requiring validation by five surgeons." The number of "test cases" or patient data involved in this usability validation is not specified.
- Accuracy Testing Test Set: Not specified in terms of patient cases. The testing involved "different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles." This implies synthetically generated or modified cases rather than a specific set of retrospective or prospective patient data from a particular country. The data provenance is described as "simulated in different virtual cases."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Functional Verification and Usability Validation, the "experts" were the "five different evaluators" and "five surgeons" respectively. Their qualifications are not explicitly detailed beyond being "surgeons" for usability.
- For Accuracy Testing, the ground truth was established by "gold standard" software: Materialise innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. No human experts are described as establishing the ground truth directly for this specific part of the testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe an adjudication method for establishing ground truth, as the accuracy testing relied on "gold standard" software rather than human consensus. For functional and usability testing, it appears to be direct observation of test results and comparison to expected outcomes.
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 MRMC comparative effectiveness study is mentioned in the document. The study described focuses on the standalone performance and accuracy of the software against "gold standard" software, and its usability. There is no comparison of human reader performance with and without AI assistance described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a form of standalone performance assessment was done, particularly in the "Accuracy Testing" section. The device's output for implant values (version and inclination) in various simulated scenarios was compared directly to the output of Materialise Innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016, which serve as the "gold standard" for these measurements. This is an evaluation of the algorithm's performance in generating specific measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the accuracy testing was established by results from "gold standard" commercial software: Materialise innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. For the functional and usability testing, the ground truth was based on expected software behavior and user experience.
The sample size for the training set:

The document does not mention the use of a "training set" or machine learning algorithms in the conventional sense that would require a separate training dataset. The device is described as "web-based surgical planning software" that provides analysis tools and 3D visualization. The performance testing focuses on verification, validation, and accuracy against "gold standard" software, rather than the performance of a machine learning model trained on a specific dataset.
How the ground truth for the training set was established:

Since no training set is mentioned or described as part of the device's development or evaluation in the document, there is no information on how its ground truth was established.

Summary

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FH Industrie % Dawn Norman Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 CENTENNIAL CO 80112

Re: K220758

September 30, 2022

Trade/Device Name: e-Ortho Shoulder Software v1.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 29, 2022 Received: August 1, 2022

Dear Dawn Norman:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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).

Sincerely,

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

510(k) Number (if known) K220758

Device Name e-Ortho Shoulder Software v1.1

Indications for Use (Describe)

E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Type of Use (Select one or both, as applicable)
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☑ For-Hire Operation with OTP, WIA Authority, or Broker Authority	☐ Own-Use Operation with OTP, WIA Authority, or Broker Authority
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary FH Industrie e-Ortho Shoulder Software v1.1 September 30, 2022

Company:	FH INDUSTRIEZI DE KERNEVEZ-6 RUE NOBELQUIMPER Finistere, FRANCE 29000
Company Contact:	Oscar Ramirez -- FH Industrie
Official Correspondent:	Dawn Norman – MRC Global, LLC
Trade Name:	e-Ortho Shoulder Software v1.1
Common Name:	System, Image Processing, Radiological
Classification:	Class II
Regulation Number:	21 CFR 892.2050 (Picture archiving and communications system)
Panel:	Radiology
Product Code:	LLZ
Predicate Device:	FH Industrie – e-Ortho Shoulder – K201928

Device Description:

Indications for Use:

E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

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Substantial Equivalence:

The subject e-Ortho shoulder software is substantially equivalent to the following predicate: FH Industrie – e-Ortho Shoulder – K201928

The subject e-Ortho Shoulder software is similar to the predicate with respect to intended use, indications for use, technological characteristics, and principles of operation. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Device	SUBJECT DEVICE	PREDICATE DEVICE
Name	e-Ortho Shoulder Software (V1.1)	e-Ortho Shoulder Software (V1.0)
Company	FH Industrie	FH Industrie
510k Clearance		K201928
Product Code	LLZ	LLZ
Indications for Use	Identical.E-Ortho shoulder is intended to be used as aninformation tool to assist in the preoperativesurgical planning and visualization of a primarytotal shoulder replacement.	E-Ortho shoulder is intended to be used as aninformation tool to assist in the preoperative surgicalplanning and visualization of a primary total shoulderreplacement.
User Poplulation	Identical.Orthopedic Surgeon	Orthopedic Surgeon
Principles of Operation	Identical.Software system with a user interface thatprovides surgeons with analysis tools to input,review, and assess fluoroscopic images to assist inimplant selection and placement during totalshoulder replacement procedures.	Software system with a user interface that providessurgeons with analysis tools to input, review, andassess fluoroscopic images to assist in implantselection and placement during total shoulderreplacement procedures.
Operating System	Identical.Mac OS 10.13 or higher and Windows 8 or higher	Mac OS 10.13 or higher and Windows 8 or higher
Image Data	Identical.CT Scan per protocol	CT Scan per protocol
Features	Identical with the following additions:• added metrics (Elbow version angle (iflandmarks contain an elbow axis), Native roll,Angle of glenoid version and inclination for native	Pre-operatively: • Helps a surgeon betterunderstand patient-specific anatomy prior to surgery• Provides surgeon three-dimensional (3D)visualization in of implant placement priorto surgery, allowing for the following:
Device	SUBJECT DEVICE	PREDICATE DEVICE	K220758
	glenoid displayed on 2D views, and Optional extra axis version & inclination) inclusion of more information to be provided about the surgeon and the patient new rendering mode displays, new optional model visualization minor display improvements Expanded correction range to support an extra surgical technique planning (double reaming) if required inclusion of a free planning mode where user can select any value of glenoid correction, in a predefined range Improved keel perforation detection and its visualization Improved prosthesis translation by sliding and rolling the implant into the selected glenoid sphere surface Ability to compute, display, and adjust glenoid graft (3D rendering Width, Height, Thickness max). Adapt planning reference surface to support an extra category of glenoid deformities (bi-concavity) deformity. Added ability to activate and select sphere surface reference in case of bi-concavity (Paleo-glen or Neo-glen). "Relative" angles and reference sphere surface for translating the glenoid implant are based on the selected sphere. Ability to visualize shoulder offset distances (lateralization...) if reduced joint page has been visited. Improved screw perforation detection by adding more perforation landmarks Improved GUI texts. Improve Warnings texts	more appropriate implant selection and sizing. Possible prevention of unintended perforations and complications due to selection of the incorrect implant or screw sizes Better prediction of the optimal option for implant positioning and screw placement Pre-operative, three-dimensional visualization provides landmarks to the surgeon for better pre-surgical preparation and planning Separate screens for each phase of planning: review of patient anatomy, glenoid placement planning, and screw placement planning. Subluxation visualization in 2D and 3D

Table 1: Comparison of Subject and Predicate Devices

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Performance Testing:

In order to ensure the performance of the e-Ortho throughout the project's development, a verification and validation process has been established and conducted per IEC 62304. The verification process was implemented through five test campaigns and was carried out by five different evaluators in two different environments to verify the functional components of the subject device. Three bugs were identified as remaining problems after the debugging campaign; however, all are minor and not expected to impact the planning itself.. The validation process was implemented through a usability test campaign, with critical features requiring validation by five surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Similar to the predicate device, additional accuracy testing was carried out to guarantee the performance of e-Ortho as follows: the

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sequence of events which could lead to dangerous situations and potential harms were identified then simulated in different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles. These simulations were carried out using the subject device, compared to the "gold standard" Materialise innovation Suite (Mimics V 22 and 3matic V 14) and SolidWork 2016 for implant values (version and inclination). All tests passed. Thus, the accuracy of e-Ortho is adequate to provide safe use of the product.

*Note: e-Ortho shoulder is intended to be used only with the following previously cleared FH Orthopedic implants: Arrow Anatomical shoulder prostheses (K093599, K162068), Arrow Reverse shoulder prostheses (K112193, K142778, K171789).

Conclusion

The e-Ortho Shoulder software v1.1 is shown to be substantially equivalent to its previously cleared version, e-Ortho Shoulder Software (K201928). The subject software has similar intended uses, indications, technological characteristics, and principles of operation as its predicate device. The minor differences do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, performance data demonstrate that e-Ortho raises no new questions of safety or effectiveness. Thus, the updated e-Ortho Shoulder software is substantially equivalent to the previously cleared version.

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).