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.

AI/ML Overview

The provided text describes the e-Ortho Shoulder Software, a web-based surgical planning tool for primary total shoulder replacement. It outlines the device's intended use, its substantial equivalence to a predicate device, and a general overview of performance testing but lacks specific details regarding acceptance criteria, study design, and results.

Here's an analysis based on the provided information, with explicit statements about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The result of the validation tests coincides with the expected results for each test case and no test failed." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the e-Ortho Shoulder Software. It vaguely states that accuracy testing was carried out to "guarantee the performance," but no specific results are shared.

Acceptance Criteria (Missing)	Reported Device Performance (Missing specific metrics)
Specific quantitative thresholds for implant sizing accuracy, positioning accuracy, or visualization fidelity.	The validation tests coincided with expected results, and no test failed. Accuracy testing was carried out.
Usability metrics (e.g., time to complete a planning task, error rate in planning).	Usability test campaign conducted with multiple surgeons; results coincided with expected results.
Software stability and reliability (e.g., uptime, crash rate).	Verification process implemented through multiple test campaigns carried out by various evaluators and environments.

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

The document states:

"The validation process was implemented through a usability test campaign, with critical features requiring validation by multiple surgeons."
"Additional accuracy testing was carried out to guarantee the performance of e-Ortho."

The exact sample size used for the test set is not specified. We only know that "multiple surgeons" were involved in the usability testing.

The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.

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

The document mentions "multiple surgeons" for usability testing, but it does not explicitly state how many experts were used to establish the ground truth for any accuracy testing, nor does it detail their qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from experts is mentioned or described in the provided text.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted comparing human readers with and without AI assistance. The focus is on the device as a planning tool for surgeons rather than an assistive AI for diagnostic reading. It mentions that "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," suggesting a comparison, but no formal MRMC study is detailed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done:

The e-Ortho Shoulder Software is described as an "information tool to assist in the preoperative surgical planning" and states that "the chosen procedure is the responsibility of the Surgeon." It clarifies that an "e-Ortho engineer provides inputs via the e-Ortho software." This suggests that the device operates within a human-in-the-loop workflow, providing tools and visualizations.

While accuracy testing was mentioned, it's not clear if a standalone performance evaluation of the algorithm without human interaction for implant sizing, positioning, etc., was performed and reported. The summary emphasizes its role as an assistive tool for surgeons, with an engineer providing inputs.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any accuracy testing. Given its use for surgical planning, potential ground truth sources could include:

Expert Consensus: Likely for the "expected results" in validation tests.
Pathology/Outcomes Data: Not mentioned, but ideal for long-term clinical validation.
Physical measurements/ Cadaveric studies: Not mentioned.

The specific source of ground truth for accuracy claims is not detailed.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for the training set used to develop or train the e-Ortho Shoulder Software. As a pre-market submission, such details about model development are often included.

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

Similar to question 8, since no information regarding a training set is provided, there is no mention of how the ground truth for any potential training set was established.

Summary

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September 30, 2020

Image /page/0/Picture/1 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 logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

FH Industrie % Ms. Dawn Norman Exec VP MRC Global, LLC 9085 East Mineral Circle, Suite 110 CENTENNIAL CO 80112

Re: K201928

Trade/Device Name: e-Ortho Shoulder Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 9, 2020 Received: July 14, 2020

Dear Ms. 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 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 Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K201928

Device Name e-Ortho Shoulder Software

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

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K201928 510(k) Summary FH Industrie e-Ortho Shoulder Software September 9, 2020

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
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

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.

Substantial Equivalence:

The subject e-Ortho Shoulder Software is substantially equivalent to the following predicate: JointPoint, Inc. JointPoint - K160284

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Both the subject and predicate devices are image processing softwares intended to aid in planning and positioning orthopedic components during orthopedic surgical procedures by using radiographic imaging to map anatomic landmarks and dimensions. However, the major differences between the subject and predicate device are that the subject e-Ortho software is only intended to be use before surgery as a preplanning tool, while the predicate JointPoint covers a broader range of the surgical workflow. However, the indications for use for the predicate fully encompass the indications for use of e-Ortho Shoulder software. Therefore, this difference does not alter the intended use or otherwise raise new questions compared to the predicate. Additionally, the subject e-Ortho Shoulder software is specific in its indication for arthroscopic total shoulder replacement procedures, while the predicate device is specific to total hip replacement, total knee replacement, and intertrochanteric fracture reduction procedures . However, this minor difference in anatomical location does not alter the intended use of the device and thus, does not raise new questions of safety or effectiveness.

Both the subject and predicate softwares include software prediction of optimal implant sizing as a preoperative planning tool. While e-Ortho's software will be used to provide implant sizing and selection recommendations to the surgeon, the inputs of these recommendations are not generated by the software like JointPoint. Rather, the analysis of the patient CT Scans are performed by an e-Ortho engineer after CT scans are uploaded by the surgeon is then able to virtually visualize potential placement implants but using landmarks populated into the e-Ortho software by the e-Ortho engineer, enabling the surgeon to choose the optimal implant type, sizing, and position. All implant selection and sizing options are specific to previously cleared FH Orthopedic shoulder implants and sizes from the FH Orthopedic Arrow Anatomic and Arrow Reverse shoulder systems. While an e-Ortho engineer provides inputs via the e-Ortho software, the chosen procedure is the responsibility of the Surgeon. Prior to any shoulder surgery, the surgeon should evaluate and validate the appropriateness of the procedure to the specific patient based on his/her medical training.

As discussed above, 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.

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 multiple test campaigns and was carried out by various evaluators and environments to verify the functional components of the subject device. The validation process was implemented through a usability test campaign, with critical features requiring validation by multiple surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Additional accuracy testing was carried out to guarantee the performance of e-Ortho.

Conclusion

The e-Ortho Shoulder software is shown to be substantially equivalent to its predicate, JointPoint. The subject software has similar intended uses, indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications 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 e-Ortho Shoulder software 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).