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The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.

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

The Arthrex 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.

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

The Arthrex 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 COS 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 Baseplate component.shoulder systems.

The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component.

This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.

The provided text describes a 510(k) submission for the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) and associated components. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria. The document primarily focuses on the device's intended use, regulatory classification, and its substantial equivalence to predicate devices, with a brief mention of verification/validation testing.

Therefore, I cannot provide the detailed information requested in the prompt based on the given text. The "SUMMARY OF VERIFICATION/VALIDATION TESTING" section is very high-level and lacks the specifics required to answer your questions.

To answer your questions accurately, I would need a document that describes:

• Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device.
• Thresholds or targets for these metrics that constitute "acceptance."
• Detailed methodology of studies (e.g., test set demographics, ground truth establishment, reader studies if applicable, statistical analysis).

Without this information, any attempt to populate the requested table or answer the specific questions would be speculative and inaccurate.

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