The VIP 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 VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines.

The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement.

The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.

The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.

The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

Device Description

Arthrex Virtual Implant Positioning (VIP) System software comprises VIP Web Portal software and OrthoVis Preoperative Plan software. The VIP Web Portal is web-based software intended for use to facilitate the upload of medical images, preoperative planning, and plan approval of placement and orientation of total joint replacement components. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the VIP Web Portal by Arthrex technicians and used to create preoperative plans in OrthoVis (a desktop application). Once created, the preoperative plans are uploaded back to the VIP Web Portal, where the surgeon user is then able to login and review the preoperative plan. Subsequently, the surgeon user may either approve the plan, or modify the type, size, location and/or orientation of the joint replacement component and then approve the plan. The approved plan is then made available for download by the surgeon user.

AI/ML Overview

This document, being a 510(k) Summary from the FDA for a medical device (K230904: Arthrex Virtual Implant Positioning (VIP) System), primarily focuses on demonstrating substantial equivalence to a predicate device. While it mentions software verification and validation, it does not contain the specific details of acceptance criteria for performance, nor a detailed study proving the device meets those criteria, as one would typically find in a clinical or performance study report.

The information provided largely outlines the device's purpose, indications for use, and a summary of technological characteristics compared to predicates. It confirms that "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.'" It also states that "Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing." However, these are general statements about development and testing processes, not detailed performance study results against specific acceptance criteria.

Therefore, many of the requested items cannot be definitively extracted from the provided text. The document describes that performance testing was done, but not what the acceptance criteria were or the results of those tests in a quantifiable manner as you've requested.

Here's an attempt to answer based on the absence of information and what can be inferred:

Acceptance Criteria and Study for Arthrex Virtual Implant Positioning (VIP) System (K230904)

Based on the provided 510(k) Summary, specific quantitative acceptance criteria for device performance and the detailed results of a study proving those criteria are not explicitly stated or provided in this document. The summary indicates that software verification and validation testing were conducted according to FDA guidance, which generally implies functional, performance, and safety testing. However, it does not disclose the specific metrics or thresholds used for acceptance, nor the results achieved.

What can be inferred or stated as "not provided":

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The general statement about "Software verification and validation testing were conducted" does not include a table of specific performance metrics (e.g., accuracy of implant positioning, measurement precision) with defined acceptance criteria and corresponding reported performance values.
Sample Size Used for the Test Set and Data Provenance: This information is not provided. The document mentions general validation and verification activities but no details about the size or nature of any test sets (e.g., number of patient cases, images) or their provenance (country of origin, retrospective/prospective).
Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. The document does not describe the establishment of ground truth for any performance testing, nor does it mention the involvement or qualifications of experts for this purpose.
Adjudication Method for the Test Set: This information is not provided. Given that details on ground truth establishment are absent, the adjudication method is also not mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This information is not provided. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it mention any effect sizes related to such a study. The device is a "preoperative planning software" primarily for displaying/editing implant placement, suggesting its role might be more about facilitating existing workflows rather than direct "AI assistance" in diagnosis requiring an MRMC study. However, the details are unclear.
Standalone (Algorithm Only) Performance: This information is not provided in terms of specific metrics and results. The emphasis is on the software supporting a workflow ("displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians"). While software verification/validation would include testing the algorithm's functionality, the document does not present quantitative standalone performance figures (e.g., accuracy of automated segmentation if applicable, though it notes "segmentation is automated (but manually verified)").
Type of Ground Truth Used: This information is not provided. There is no mention of whether ground truth was based on expert consensus, pathology, surgical outcomes, or another method.
Sample Size for the Training Set: This information is not provided. No details about a training set for any machine learning components are mentioned.
How the Ground Truth for the Training Set Was Established: This information is not provided. As no training set details are given, how its ground truth was established is also not discussed.

Conclusion from the Document:

The 510(k) Summary serves to demonstrate "substantial equivalence" of the Arthrex Virtual Implant Positioning (VIP) System to a predicate device, specifically for expanded indications related to humeral components. It states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance." This implies that the necessary internal testing and documentation were completed to satisfy regulatory requirements for demonstrating functional capabilities and safety, but the specifics of those tests, including quantitative acceptance criteria and results, are not detailed in this public summary document. For such detailed performance data, one would typically need to consult a more comprehensive clinical or performance study report, which is not part of this 510(k) summary.

Summary

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June 22, 2023

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

Arthrex Inc. Troy Brooks Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K230904

Trade/Device Name: Arthrex Virtual Implant Positioning (VIP) System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE Dated: April 19, 2023 Received: April 21, 2023

Dear Troy Brooks:

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.

Farzana Sharmin -S

Farzana Sharmin, Ph.D. 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) K230904

Device Name

Arthrex Virtual Implant Positioning (VIP) System - VIP Web Portal

Indications for Use (Describe)

The VIP 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 Ortho Vis desktop software by trained Arthrex technicians.

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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Indications for Use

510(k) Number (if known) K230904

Device Name

Arthrex Virtual Implant Positioning (VIP) System - OrthoVis Preoperative Plan

Indications for Use (Describe)

The Ortho Vis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement.

The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.

The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

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.

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."

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510(k) Summary

Date Prepared	June 21, 2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Troy Brooks, RACManager, Regulatory Affairs1-239-643-5553Troy.Brooks@Arthrex.com
Name of Device	Arthrex Virtual Implant Positioning (VIP) System
Common Name	Preoperative Planning Software
Product Code	QHE
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class	II
Primary Predicate	K222007: Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and OrthoVis Preoperative Plan)
Additional Predicate	K213546: Blue Ortho ExactechGPS Total Shoulder Application/Equinoxe Planning Software
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance for new preoperativeplanning of humeral components in total shoulder arthroplasty and associated expanded indicationsfor use for the existing Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal andOrthoVis Preoperative Plan) cleared under K222007.
Device Description	Arthrex Virtual Implant Positioning (VIP) System software comprises VIP Web Portal software andOrthoVis Preoperative Plan software. The VIP Web Portal is web-based software intended for use tofacilitate the upload of medical images, preoperative planning, and plan approval of placement andorientation of total joint replacement components. Each surgeon user's uploaded images are groupedinto cases and associated with that user's profile. Uploaded images can be downloaded from the VIPWeb Portal by Arthrex technicians and used to create preoperative plans in OrthoVis (a desktopapplication). Once created, the preoperative plans are uploaded back to the VIP Web Portal, where thesurgeon user is then able to login and review the preoperative plan. Subsequently, the surgeon usermay either approve the plan, or modify the type, size, location and/or orientation of the jointreplacement component and then approve the plan. The approved plan is then made available fordownload by the surgeon user.
Indications for Use	The VIP Web Portal is intended for use as a software interface and for the transfer of imaginginformation from a medical scanner such as a CT scanner. It is also intended as software fordisplaying/editing implant placement and surgical treatment options that were generated in theOrthoVis desktop software by trained Arthrex technicians.The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVispreoperative plan. It is indicated for use with the following implant lines: UniversTM II and UniversTMApex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoidcomponent, as well as the Univers ReversTM baseplate component (Universal Glenoid), Univers ReversTMmodular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with theseimplant lines.The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitatesaccurate preoperative planning of glenoid and humeral components in total shoulder replacement, andintraoperative placement of the glenoid component in total shoulder replacement.The VIP Glenoid Targeter is indicated for use with the UniversTM II and UniversTM Apex total shouldersystems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well asthe Univers ReversTM baseplate component (Universal Glenoid) and Univers ReversTM modular glenoidsystem (MGS) baseplates.

Indications for Use(continued)	The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and theUnivers Revers™ modular glenoid system (MGS) baseplates.The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan isintended to be used are the same as those described in the labeling for these shoulder systems.
Summary ofTechnologicalCharacteristics	As compared to the primary predicate device used for preoperative planning of glenoid components,the subject device now includes preoperative planning of both glenoid components and humeralcomponents.Both the subject device and the additional predicate device include preoperative planning of glenoidcomponents and humeral components. The primary differences between subject device and theadditional predicate are minor visual and layout differences in the user interface, and segmentation isperformed manually for the additional predicate, whereas segmentation is automated (but manuallyverified) with the subject device.
Performance Data	Software verification and validation testing were conducted and documentation was provided asrecommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices." The software was considered as a "major"level of concern. Activities included software validation/verification, regression testing, unit testing,code reviews and checks and integration testing.
Conclusion	Based on the intended use, fundamental scientific technology, and the data provided in this Traditional510(k), Arthrex has determined that the Arthrex Virtual Implant Positioning (VIP) System software (VIPWeb Portal and OrthoVis Preoperative Plan) is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”