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The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and 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 intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. 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 VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.
The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ II and 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.
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 glenoid implant lines: Univers™ II and 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.

Device Description

The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use with the Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components are within the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIP glenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific: Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). The reaming depth settings for the subject devices is provided with the surgeon approved plan.

AI/ML Overview

The Arthrex Virtual Implant Positioning (VIP) System (K222007) is a medical device designed to facilitate preoperative planning and intraoperative placement of glenoid components in total shoulder replacement. The system comprises the VIP Glenoid Targeter (manual instrument system), VIP Glenoid Reamer, OrthoVis pre-operative plan (software-generated plan), and the VIP Web Portal (software interface for imaging and plan display/editing).

1. Acceptance Criteria and Reported Device Performance:

The provided text details performance data for the VIP Glenoid Reamers and the overall VIP System. Since this is a 510(k) submission, the primary acceptance criteria revolve around substantial equivalence to predicate devices, demonstrating that the subject device performs as intended and does not raise new questions of safety or effectiveness. Specific numerical acceptance criteria were not explicitly stated in the provided summary, but the general criteria and reported performance can be summarized as follows:

Acceptance Criteria (Inferred from 510(k) approach)	Reported Device Performance
Functional Equivalence: Device performs as intended, facilitating accurate preoperative planning and intraoperative placement of glenoid components.	Demonstrated Function: "Design verification (compression testing and side-by-side testing) and cadaver validation were performed." "The verification and validation activities conducted for the subject VIP glenoid reamers demonstrates that it performs as intended for the desired indications."
Depth Control Accuracy (VIP Glenoid Reamers): Maintains appropriate control over reaming depth.	Accuracy Demonstrated: "Side-by-by-side testing with the standard reaming method was conducted to assess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System." (Specific accuracy metrics not provided, but implies satisfactory performance).
Software Functionality and Safety: Software components (OrthoVis Preoperative Plan, VIP Web Portal) are properly verified and validated, and do not introduce new safety or effectiveness concerns.	Software V&V Completed: "Software verification and validation testing of the Arthrex VIP Web Portal software and Arthrex OrthoVis Desktop software 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." 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."
Overall System Safety and Effectiveness: The entire VIP system, including the new reamers and modifications, is safe and effective for its intended use.	Established Safety and Effectiveness: "Cadaveric validation was performed to validate the related user needs, intended use, safety and effectiveness of the subject VIP glenoid instrumentation." "The overall planning process, materials, sterilization methods, principles of operation, have not changed from the predicates. Any differences with the predicate are considered minor and do not raise questions regarding safety or effectiveness."
Material Biocompatibility/Safety: Materials used are safe for their intended application.	Material Equivalence: "subject VIP glenoid reamers are made of stainless-steel." "The overall planning process, materials, sterilization methods, principles of operation, have not changed from the predicates." (Implies materials are known and safe, similar to predicates).

2. Sample Size for Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated for either the mechanical testing (compression, side-by-side) or the cadaveric validation.
Data Provenance: The cadaveric validation implies human anatomical specimens were used, likely from a cadaver lab setting. The country of origin is not specified but commonly such studies are conducted in the country of device development or major academic centers. The study appears to be prospective in nature, as new tests were conducted for the device.

3. Number of Experts and Qualifications:

For Cadaveric Validation: Not explicitly stated how many experts were involved or their specific qualifications. However, such studies typically involve orthopedic surgeons specializing in shoulder surgery to assess the surgical workflow and outcomes.
For Software Verification & Validation: The summary mentions "trained Arthrex technicians" generating surgical treatment options in the OrthoVis desktop software. These technicians would likely be experts in the use of the software and anatomical planning.

4. Adjudication Method:

The document does not specify an adjudication method for the testing or validation activities.

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

No mention of an MRMC comparative effectiveness study being performed to assess the effect size of human readers improving with AI vs. without AI assistance. The device is for pre-operative planning and intra-operative guidance, not a diagnostic AI tool for image interpretation by multiple readers.

6. Standalone (Algorithm Only) Performance:

The software components (OrthoVis Preoperative Plan, VIP Web Portal) represent the "algorithm only" parts of the system for planning and displaying information. The summary states that "Software verification and validation testing... were conducted". This implies that the standalone performance of the software was assessed for its intended functions, such as accurate planning and display, as part of the V&V process. However, specific metrics for standalone performance are not provided.

7. Type of Ground Truth Used:

For Mechanical Testing (Compression and Side-by-Side): The ground truth would be precise engineering measurements and pre-defined specifications for depth control and material properties.
For Cadaveric Validation: The ground truth would be the actual anatomical landmarks and the accuracy of implant placement achieved within the cadaveric model, often verified through post-procedure imaging or dissection.
For Software Verification & Validation: The ground truth for software would be the expected output based on validated algorithms and reference data, ensuring internal consistency and correctness of computations and displays.

8. Sample Size for Training Set:

The document does not provide information about a "training set" in the context of machine learning or AI models. This device appears to be rule-based or algorithm-based software for planning, rather than a machine learning model that requires a distinct training set. The "trained Arthrex technicians" mentioned are users of the software, not data for a training set.

9. How Ground Truth for Training Set Was Established:

As the document does not indicate the use of a machine learning training set, this question is not applicable.

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