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VIP Web Portal:
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.

OrthoVis Preoperative Plan:
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™ 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.

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 shoulder 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.

The provided text contains a K241097 510(k) summary for the Arthrex Virtual Implant Positioning (VIP) System Software. It describes the device, its indications for use, and a summary of technological characteristics. However, it does not include detailed information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, the "Performance Data" section states: "Software verification and validation testing were conducted and Enhanced Level documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff 'Content of Premarket Submissions for Device Software Functions' dated June 14, 2023. Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing." This is a general statement about software testing but does not provide specific acceptance criteria or study results for device performance, especially in relation to human reader improvement with AI assistance, standalone algorithm performance, or details about the ground truth establishment.

Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of what the document does not include from your request:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "software verification and validation testing" but no specific performance metrics or acceptance thresholds are listed.
2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: Not provided. The device description focuses on planning software, not an AI to assist human readers in a diagnostic setting.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used: Not explicitly stated for performance testing. For the planning software, the "ground truth" would likely be the accurate simulation/prediction of implant placement, which is established by comparing the software's output to engineering/anatomical specifications and possibly surgical outcomes, but this is not detailed.
8. The sample size for the training set: Not applicable based on the information provided, as this is software for preoperative planning, not a machine learning model that typically involves a "training set" in the sense of clinical image analysis. The "OrthoVis desktop application" is where technicians create plans.
9. How the ground truth for the training set was established: Not applicable for the reasons above. The "ground truth" for this type of software would be based on validated anatomical models and biomechanical principles used to develop the software's algorithms for implant positioning.

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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.

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.

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":

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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)").

7. 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.

8. Sample Size for the Training Set: This information is not provided. No details about a training set for any machine learning components are mentioned.

9. 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.

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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.

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.

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:

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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