The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained Arthrex technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.

Device Description

The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by Arthrex technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by Arthrex technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.

AI/ML Overview

The ArthrexVIP Web Portal is a software device intended for managing imaging information and displaying/editing implant placement and surgical treatment options for shoulder joint replacement.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the ArthrexVIP Web Portal in a typical medical device performance study context (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the "acceptance criteria" are implied by the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. The performance is assessed through various software testing methodologies rather than clinical outcomes or diagnostic accuracy.

Implied Acceptance Criteria (based on testing performed):

Acceptance Criteria Category	Description (as implied by testing)	Reported Device Performance
Software Functionality	The software must function as intended for uploading, transferring, displaying, and editing imaging information and surgical plans, maintaining data integrity, and allowing for plan approval/modification. Changes from predicate must be correctly integrated.	Successfully passed Software Verification and Validation.
Software Quality	The software code must be robust, free of critical defects, and correctly integrated.	Successfully passed Regression Testing, Unit Testing, Code Reviews and Checks, Integration Testing.
Dimensional Accuracy	The display/editing of implant placement and surgical treatment options, including new implant models and features, must be dimensionally accurate and consistent with the intended design.	Successfully passed Dimensional Verification.
Intended Use Fulfillment	The device fulfills its intended use as a software interface, for transfer of imaging data, and for displaying/editing plans generated by trained Arthrex technicians, for the specified glenoid implant lines, including the added Modular Glenoid System baseplate.	Demonstrated through software testing that the device functions as described for its intended use and expanded implant lines.

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

The document does not specify a sample size for a test set in the traditional sense of a clinical or imaging dataset. The testing performed is primarily software verification and validation, regression testing, unit testing, code reviews, integration testing, and dimensional verification.

Test Set: Not applicable in the context of clinical images/data. The "test set" would refer to the various software modules, functions, and simulated data used during the V&V processes.
Data Provenance: Not applicable. No patient data provenance is mentioned as this is not a device that directly analyzes patient data for diagnostic or treatment recommendations. The "data" being tested are software inputs, outputs, and internal states.

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

This information is not provided and is generally not applicable for this type of software-only device where "ground truth" relates to functional correctness and dimensional accuracy rather than clinical interpretation of medical images. For dimensional verification, engineers or subject matter experts in CAD/imaging might define the "ground truth" for measurements, but the document does not elaborate.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable. Software testing typically involves predefined test cases and expected outcomes. Discrepancies would be logged as bugs and resolved, rather than adjudicated by multiple experts in a consensus-based manner.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence to the predicate." This device is a software portal for image transfer and display/editing of pre-generated plans, not an AI diagnostic tool or an imaging modality that requires human reader performance evaluation.

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

Not applicable in the context of typical AI/CADe/CADx devices. This device is a portal and editing tool; it doesn't have an "algorithm" in the sense of making independent diagnostic or treatment recommendations that would require standalone performance metrics like sensitivity or specificity. Its standalone performance is assessed through its software verification and validation processes (i.e., does it perform its specific functions correctly, reliably, and accurately as a piece of software).

7. Type of Ground Truth Used

For the non-clinical testing:

Software Verification and Validation, Regression Testing, Unit Testing, Code Reviews, Integration Testing: The ground truth is the software requirements specification and design documentation. The software must perform according to these documented specifications.
Dimensional Verification: The ground truth would be based on engineering specifications, CAD models, or established measurement standards for the implant models and visualization tools.

8. Sample Size for the Training Set

Not applicable. The ArthrexVIP Web Portal is a software tool for data transfer, display, and editing of pre-generated plans. It does not utilize machine learning or AI that requires a "training set" of data.

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

Not applicable, as there is no training set.

Summary

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April 30, 2020

Arthrex Inc. Heli Chambi Infantas Sr. Regulatory Affairs Associate 1370 Creekside Blvd NAPLES, FL 34108

Re: K193523

Trade/Device Name: ArthrexVIP Web Portal Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 28, 2020 Received: March 31, 2020

Dear Heli Chambi Infantas:

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 (OS) 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.

Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices 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)

K193523

Device Name ArthrexVIP Web Portal

Indications for Use (Describe)

The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scamer such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained Arthrex technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K193523

	510(k) Summary
510(k) SPONSOR / MANUFACTURER:	Arthrex Inc.1370 Creekside BlvdNaples, FL 34108
CONTACT PERSON:	Heli F. Chambi InfantasSr. Regulatory Affairs Associate1-239-598-4302, ext. 73187Heli.Chambiinfantas@arthrex.com
TRADE NAME:	ArthrexVIP Web Portal
DATE PREPARED:	16-Dec-2019
COMMON NAMES:	Image processing system and preoperative softwarefor simulating / evaluating implant placement andsurgical treatment options

Product	ProductCode	Regulation andClassification Name	DeviceClass
ArthrexVIP WebPortal	LLZ	21 CFR 892.2050Picture Archiving andCommunications System	II

Predicate Devices:

K162697: ArthrexVIP Web Portal

Device Description:

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Intended Use and Indications:

The ArthrexVIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained Arthrex technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.

Basis of Substantial Equivalence:

The modified ArthrexVIP Web Portal has the same intended use and indications for use as the predicate ArthrexVIP Web Portal (K162697) with the exception of "COS technicians" now being "Arthrex technicians" to reflect the change in manufacturer from Custom Orthopaedic Solutions (COS) to Arthrex and the addition of the Modular Glenoid System baseplate to the indicated glenoid implant lines.

The subject device is a version of the predicate device with changes to the following:

Addition of backside seating feature
Addition of the Univers Revers Modular Glenoid System (MGS) implant models
Addition of the Univers Revers Universal Glenoid (UG) implant models
Addition of the glenosphere and inlay implant models compatible with MGS and UG
Addition of glenoid bone preparation instrument models for visualization
Addition of the Univers Revers screw trajectory models for visualization

Non-Clinical Testing

The following testing was performed to demonstrate substantial equivalency of the ArthrexVIP Web Portal to the OrthoVis Web Portal:

. Software verification and validation
Regression testing
Unit testing
Code reviews and checks
Integration testing
Dimensional verification

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence to the predicate.

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).