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

The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.

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 OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.

Here's a breakdown of the acceptance criteria and study information for the Arthrex OrthoVis Preoperative Plan, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes a "Non-Clinical Testing" section that outlines the studies performed to demonstrate substantial equivalency to a predicate device. The primary performance metric mentioned is related to central guide pin placement accuracy as improved by the preoperative plan.

Given the information, we can infer the acceptance criteria and reported performance qualitatively from the "Inter and Intra User Surgical Planning Comparison Study". The goal of this study would be to show that the Arthrex OrthoVis Preoperative Plan, with the new Arthrex implants, provides comparable or improved accuracy in planning features (like the central glenoid guide pin) compared to the predicate device with its original implants.

Inferred Acceptance Criteria Table:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document. The "Inter and Intra User Surgical Planning Comparison Study" is mentioned, but details on the number of cases or users included are absent.
• Data Provenance: Not specified. There is no information regarding the country of origin of the CT scans or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The document does not explicitly state how ground truth was established, nor does it specify the number or qualifications of experts for the test set. The study type ("Inter and Intra User Surgical Planning Comparison Study") suggests that potentially human planners (surgeons or trained personnel) were involved in generating plans, which were then compared, but it does not clarify if these plans themselves served as a ground truth or if an independent "true" surgical plan was used for comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The adjudication method is not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• The document mentions an "Inter and Intra User Surgical Planning Comparison Study." This study design often involves multiple users (readers/planners) creating plans for multiple cases, which aligns with the "multi-reader multi-case" concept. However, it's not strictly an AI-assistance study in the sense of comparing human performance with and without an AI diagnosis/recommendation. Instead, the device is a planning tool that facilitates planning.
• The study's goal was to demonstrate substantial equivalence to a predicate device. It's likely comparing the planning outcome (e.g., pin placement accuracy) when using the OrthoVis software with the new Arthrex implants versus potentially the predicate device's software with its specific implants, or against a manual planning method.
• Effect Size: The document does not provide any effect size or numerical improvement metrics for human readers using the device. It only states that the testing was performed to demonstrate substantial equivalency.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone (algorithm only) performance study is not described. The device is explicitly a "preoperative plan created via the OrthoVis software" that "facilitates accurate preoperative planning and intraoperative placement." This implies a human-in-the-loop process where the software is a tool for a planner/surgeon. The "Inter and Intra User Surgical Planning Comparison Study" further supports this by involving human users.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The type of ground truth is not explicitly stated. For a planning tool, ground truth would ideally be the "optimal" or "correct" surgical plan/placement. This could be established by:
  • Expert Consensus: Multiple highly experienced surgeons or planners agreeing on an optimal plan.
  • Pathology/Intraoperative Images: Post-operative imaging or intraoperative photos confirming the actual placement of components (though this is more for verification than establishment of the preoperative ground truth).
  • Biomechanical Simulation: Computational models determining ideal placement based on patient-specific anatomy and biomechanics.
• Given the nature of the device, it's most probable that an expert consensus or a gold-standard manual planning method was used as a reference for comparison, but the document does not confirm this.

8. The sample size for the training set

• The document does not refer to a training set. This product is described as software that uses patient CT scans to create a preoperative plan. While the software itself would have been developed and "trained" in a broader sense (e.g., development of segmentation algorithms), this 510(k) summary focuses on the validation of the software's output for a specific clinical application (new implants). There is no mention of machine learning or deep learning models that require a distinct "training set" in the context of this regulatory submission. "Software verification and validation" generally refers to traditional software engineering testing.

9. How the ground truth for the training set was established

• As no training set is mentioned in the context of this regulatory submission, there is no information on how its ground truth would have been established.

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