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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 VIP Web Portal is intended for use as a software interface 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 Apex, Arthrex Univers II, and Arthrex Univers Revers.

The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.

The provided document is a 510(k) summary for the ArthrexVIP Web Portal, which is a software device intended for use in preoperative planning for shoulder joint replacement. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.

Here's an attempt to answer the questions based on the limited information available in the document, along with an explanation of why certain information cannot be provided:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics tied to such criteria. The submission focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing, rather than establishing performance against defined criteria.

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

The document does not specify a test set sample size or data provenance for any clinical performance evaluation. The non-clinical testing performed includes "Software verification and validation," "Regression Testing," "Unit Testing," "Code reviews and checks," and "Integration Testing." These are software development and quality assurance activities, not studies involving human subjects or medical image data in a clinical context.

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)

No information is provided regarding experts, ground truth establishment, or clinical test sets.

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

No information is provided regarding adjudication methods, as no clinical test set is described.

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

No MRMC study was mentioned or performed. The device is a "software interface" for displaying/editing implant placement and surgical treatment options, not an AI-assisted diagnostic tool that would typically involve improving human reader performance.

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

No information is provided about a standalone algorithm performance study. The device is described as a "software interface" and a tool for displaying/editing options generated by "trained COS technicians" and reviewed by "surgeon users," indicating a human-in-the-loop design.

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

The document does not describe the establishment of a "ground truth" in a clinical sense for performance evaluation. The testing performed ("Software verification and validation," etc.) would involve internal quality metrics and ensuring the software functions as designed, rather than comparison to a clinical ground truth.

8. The sample size for the training set

No training set is mentioned. This device is not described as an AI/ML algorithm that learns from data in a training set. It is a software interface and planning tool.

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

Not applicable, as no training set for an AI/ML algorithm is described.

Summary of what can be extracted from the document regarding acceptance criteria and studies:

The document states:

• Non-Clinical Testing: "The following testing was performed to demonstrate substantial equivalency of the ArthrexVIP Web Portal to the OrthoVis Web Portal: Software verification and validation, Regression Testing, Unit Testing, Code reviews and checks, Integration Testing, Dimensional Validation (performed on predicate device and code has not changed for the subject device)."
• Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between to the predicate."

This 510(k) submission relies on non-clinical software validation and verification activities to establish substantial equivalence to a predicate device, rather than explicit clinical performance criteria with associated studies involving patient data or experts. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and human reader performance is not present in this document.

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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 Apex, Keeled or Pegged Glenoid components 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 SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K151500) to be set according to prescribed lengths and heights for a specific patient's glenoid anatomy. The IRI leg lengths and their respective heights are determined in the OrthoVis software which is a part of the Arthrex Glenoid IRIS system. Along with the IRI leg lengths for each IRI slot and their respective heights, images of where the IRI was planned to sit on the patient's glenoid for the prescribed leg lengths and heights are given.

Loading the IRI device according to the prescribed lengths, setting the height of each IRI leg according to the prescribed SmartBase ruler heights, and then placing the IRI on the glenoid according to the preoperative plan images allows the IRI to transfer the guide pin for the surgeon-approved, preoperatively-planned glenoid implant trajectory to the patient in the OR. It provides the same function as the SmartBone (setting the IRI device), which was previously cleared in the predicate, K151500.

The document describes the SmartBase for Arthrex Glenoid IRIS, a reusable instrument intended to facilitate the intraoperative placement of the central glenoid guide pin during total shoulder replacement surgery. The device is a "patient-specific manual instrument system" designed to interface with the Arthrex Glenoid IRIS system.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly mentions a "SmartBase vs. SmartBone Comparison Study." However, it does not specify the sample size used for this test set (e.g., number of cases, number of measurements).

The document also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for this comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the comparison study. Given the nature of comparing instrument performance in placing a guide pin, the "ground truth" likely referred to the preoperatively planned pin trajectory or a direct measurement of the achieved pin trajectory relative to the plan, rather than a diagnostic interpretation by experts.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No, an MRMC comparative effectiveness study was not done. This device is a manual surgical instrument, not an AI or imaging diagnostic device. The study focused on comparing the performance of two physical instruments (SmartBase vs. SmartBone).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm-only) performance study was not done. The SmartBase is a manual instrument used by a surgeon, and its performance is inherently tied to human interaction.

7. The Type of Ground Truth Used

The "ground truth" in the "SmartBase vs. SmartBone Comparison Study" appears to be defined by the preoperatively planned glenoid guide pin trajectory and the planned IRI leg heights. The comparison aimed to determine if the SmartBase could achieve these planned parameters as effectively as the predicate SmartBone. This is essentially a metrological or accuracy-based ground truth related to surgical planning and execution.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a mechanical instrument, not an AI algorithm that requires training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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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 Apex, Keeled or Pegged Glenoid components 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 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 Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K142072, except for the following differences:

• The Glenoid IRIS for the K142072 clearance was indicated for use with the DePuy family of shoulder replacement systems. The subject device is indicated for use with the Arthrex family of glenoid components, which includes:
  • o Univers™ II and Univers™ Apex Keeled Glenoid,
  • O Univers™ II and Univers™ Apex Pegged Glenoid,
  • o Univers Revers™ Baseplate.
• The DePuy implant models in the OrthoVis planning software have been replaced with Arthrex implant models.
• -The OrthoVis User's Manual and User Training Manual contain references to the implant company's instructions as to how their glenoid implants should be placed in patients. For this current submission, the User's Manual and User Training Manual have been changed to reflect the approved labeling for how Arthrex instructs these implants to be placed in patients.

All other elements of the K142072 clearance are identical to this submission.

The provided text is a 510(k) Pre-market Notification for the Arthrex Glenoid Intelligent Reusable Instrument System (Glenoid IRIS). It states that the device is substantially equivalent to a previously cleared device (K142072) and details the non-clinical testing performed to establish this equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes the Arthrex Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) as a patient-specific manual instrument system. Its primary function is to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin for total shoulder systems that use a central guide pin to prepare the glenoid for an implant.

Since this is a 510(k) submission asserting substantial equivalence to a predicate device (Glenoid IRIS cleared in K142072), the acceptance criteria are implicitly tied to demonstrating that the modifications made (changing from DePuy to Arthrex implants in the planning software and user manuals) do not alter the safety and effectiveness of the system.

The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy of pin placement in millimeters, or successful preoperative planning rate). Instead, the performance is evaluated through verification and validation of the software and user testing to confirm accurate implant placement according to approved labeling.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document mentions "OrthoVis inter- and intra-user testing" but does not specify the sample size (e.g., number of users, number of cases/plans).
   • Data provenance is not explicitly stated. Given the nature of software testing and user testing for a medical device aiming for substantial equivalence, this data would likely be collected in a prospective manner during the validation phase, conducted by the manufacturer or a contracted entity. The country of origin is not mentioned, but the manufacturer is based in Cleveland, Ohio, USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number of experts used to establish the ground truth for the user testing.
   • It references "Arthrex approved labeling for placement of their implants," implying that the "ground truth" for correct placement is defined by the manufacturer's established guidelines and potentially by expert consensus within that framework. The qualifications of who would assess "accuracy" during user testing are not detailed.

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

   • The document does not mention any specific adjudication method. For "inter- and intra-user testing," it implies an assessment of consistency and correctness by comparing user performance against established guidelines.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The device fundamentally is the instrument system designed to assist human users (surgeons/planners). The testing focused on confirming the software and integrated system itself worked as intended, especially with the new implant models. The document states that "Clinical testing was not necessary" to determine substantial equivalence.

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

   • The document describes the "Glenoid IRIS" as a "patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin." It also refers to "OrthoVis planning software." The core of the system is the combination of software for planning and physical instruments for execution. The validation includes software verification and user testing of the integrated system. Therefore, a standalone algorithm-only performance assessment is unlikely to be fully applicable or performed in isolation for this type of system, as the human-in-the-loop is an integral part of its intended use. The software modules were verified, but their output is used by human operators.

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

   • The ground truth for the software's correct function and user's accurate implant placement is based on Arthrex approved labeling for placement of their implants. This can be considered a form of expert consensus and established procedural guidelines set by the implant manufacturer. It's not pathology or outcomes data from patients, but rather adherence to a defined standard of care/technique.

7. The sample size for the training set:

   • This document describes a 510(k) for a medical device instrument system, not a machine learning or AI algorithm in the contemporary sense that would typically involve a "training set" for model development. The "OrthoVis planning software" is a rule-based or calculative software, not a system that learns from data. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The software incorporates implant models and rules for planning based on engineering and anatomical principles as defined by the manufacturer.

8. How the ground truth for the training set was established:

   • As established in point 7, there is no "training set" in the AI/ML sense. The "ground truth" for the software's internal workings and the user manuals would be established by engineering design specifications, anatomical data, and the defined placement procedures outlined in Arthrex's approved labeling for their glenoid implants.

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The OrthoVis 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 pre-operative software for simulating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below.

• · Arthrex Univers Apex
• · Arthrex Univers II
• · Arthrex Univers Revers
• · DePuy Global AP
• DePuy Global StepTech
• · DePuy Delta Xtend Reverse

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use 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 OrthoVis Web Portal is composed of software intended for use to facilitate upload of medical images and preoperative planning and plan approval of placement and orientation of Arthrex and DePuy total shoulder replacement systems. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K13367 and K151568). The user is then able to login to the OrthoVis Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the shoulder replacement component and then approved plan is then available to download by COS technicians for further preoperative planning production (see 510(k) K123122 and K142072) and for download by the user/surgeon.

The provided document does not contain explicit acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter from the FDA to Custom Orthopaedics Solutions, Incorporated for their OrthoVis Web Portal.

The letter focuses on the FDA's determination of substantial equivalence to legally marketed predicate devices, rather than a clinical performance study with predefined acceptance criteria for the device itself. The device, OrthoVis Web Portal, is described as a software interface for transferring imaging information and pre-operative simulation, essentially a communication tool between surgeons and technicians.

However, the "NON-CLINICAL TESTING" section (page 6) describes the testing performed to demonstrate substantial equivalence, which can be interpreted as fulfilling the requirements for market clearance for this type of device.

Here's a breakdown based on the information provided, recognizing that it's not a typical clinical performance study:

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

The document does not present a table of acceptance criteria with corresponding device performance for a typical clinical study (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated relates to software functionality and safety in comparison to existing methods.

2. Sample size used for the test set and the data provenance

• Software Verification and Validation:
  • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." This testing involved numerous automated unit tests and integration tests, as well as manual tests covering various software functionalities and scenarios.
  • Data Provenance: Not applicable in the traditional sense of patient data. The "data" would be test cases and simulated inputs designed to exercise the software's capabilities and constraints.
• Dimensional Validation:
  • Test Set Sample Size: Not specified. This validation likely involved testing the software's rendering and measurement capabilities rather than a patient dataset.
  • Data Provenance: Not applicable.
• Simulated Use Comparison:
  • Test Set Sample Size: "Surgeons with experience" were asked to participate in a survey. The exact number of surgeons is not specified.
  • Data Provenance: Prospective, as surgeons were asked to compare their experiences with the old and new processes. The origin of the data is implicit as part of the manufacturer's testing in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the software verification and dimensional validation, "ground truth" would be the expected correct software behavior and measurement accuracy, established by software engineers and potentially medical imaging experts involved in the development and previous clearances of OrthoVis. Specific numbers and qualifications are not provided.
• For the simulated use comparison, the "experts" were the participating surgeons. Their qualifications are stated as "Surgeons with experience in using the OrthoVis Preoperative Plan via the CD Mailer/Go-To-Meeting/Email process." No specific number is given.

4. Adjudication method for the test set

• Not applicable in the context of a clinical performance study with human reviewers.
• Software testing would involve test engineers and potentially QA personnel verifying test outcomes against expected results.
• For the surgeon survey, presumably, the survey responses were collected and analyzed directly, not adjudicated among experts to establish a "ground truth."

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

• No, an MRMC comparative effectiveness study was not done.
• The OrthoVis Web Portal is described as a software interface for communication and pre-operative simulation, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of improving human readers with AI assistance does not apply directly to this device's intended use according to the provided text. The "Simulated Use Comparison" was about process efficiency and user experience, not diagnostic accuracy.

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

• The device is a human-in-the-loop system by design, facilitating communication and planning between surgeons and technicians. The software itself is designed to display, transfer, and allow modification of plans by human users.
• The "standalone" performance would be related to its software functionality (e.g., ability to upload, store, display data correctly), which was addressed by the software verification and validation. However, this is not a clinical "standalone" performance in the sense of making a medical decision without human input.

7. The type of ground truth used

• Software Verification and Validation: Expected software behavior, functional requirements, and logical outputs.
• Dimensional Validation: Known measurement standards and calculations, validated against established (previously cleared) software code.
• Simulated Use Comparison: User experience and feedback from surgeons, evaluated against the existing manual processes.

8. The sample size for the training set

• Not applicable. The OrthoVis Web Portal is a communication and simulation tool, not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this device.

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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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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 Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Global AP Shoulder glenoid component, Global Shoulder StepTech Anchor Peg glenoid component, or Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems.

The indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemishoulder replacement. The Indications for Use of these DePuy shoulder systems are:

DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid

The DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from:

· A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis.

· Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory.

· Other difficult clinical problems where shoulder surgery arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

The Global AP Glenoid and StepTech glenoid components are indicated only for use with bone cement.

DePuy Delta Xtend Reverse Shoulder System

· The Delta Xtend Reverse Shoulder prosthesis is intended for use as total shoulder replacement.

· The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.

• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

· In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

· Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.

· The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K123122, except for the following modifications:

• In K123122, the IRI legs were plastic, single use, and were shipped sterile in quantities of 2 of each recommended leg length. In this submission, the IRI legs are stainless steel, reusable, and are shipped non-sterile in the Glenoid IRIS instrument tray/carrier/kit for steam sterilization prior to use at the hospital where the procedure will be taking place. Each Glenoid IRIS kit contains a full set of reusable IRI legs.

• The SmartBone instruments (SmartBone-Pin Trajectory, SmartBone-Reamed, SmartBone-Fixation Feature Prep, and SmartBone-Implant) are made of a different photopolymer from K123122.

-The SmartBone instruments are shipped non-sterile and are sterilized on-site where the procedure will be taking place.

-The IRI wrench was removed from the Glenoid IRIS system and the IRI cap was modified to facilitate tightening and loosening the IRI instrument by hand. The Glenoid IRIS instrument tray was made to include a slot that could be used to replace the disassembly feature of the nubs on the IRI wrench.

-The SmartBone—Pin Trajectory instrument is pre-marked where the recommended IRI legs contact the SmartBone instrument. The marker is a non-toxic marker that is compatible with steam, EO & Sterrad Sterilization. We performed testing to determine how great the risk of the marking from the marker bleeding and or transferring when wiped with a polar and non-polar solvent. The study indicated that the marker was compatible with steam sterilization and did not undergo bleeding. Likewise, the marker did not transfer to a white rag when rubbed with a polar or non-polar solvent.

-The SmartBone mount is made of stainless-steel, is reusable, and is shipped nonsterile as part of the Glenoid IRIS system in a kit/carrier. When the SmartBone is placed on the SmartBone mount, the glenoid is positioned such that vertical is the plane of the scapula. When the SmartBone is set on its base without the SmartBone Mount, the guide pin hole is vertical for ease in setting the IRI.

-The Glenoid IRIS system includes a case/tray carrier for ease in shipping, storing, carrying, and organizing the Glenoid IRI device, the Glenoid IRI legs, the SmartBone instrument (or a place to put the SmartBone instrument, when it arrives after having been shipped separately), and the SmartBone Mount.

-Minor dimensional and aesthetic marking changes to the IRI components

This document describes the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), a patient-specific manual instrument system designed to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin in total shoulder implant systems. The current submission (K142072) is for a modified version of a previously cleared device (K123122), with changes primarily related to material, reusability, and minor dimensional alterations.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a formal table format. However, it implicitly defines acceptance by demonstrating "substantial equivalence" to the predicate device (K123122) in performance, biocompatibility, and durability.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The primary functional performance test involved an "artificial cadaver surgeon evaluation."
• Sample Size: The original Glenoid IRIS was used 5 times on an artificial cadaver, and the modified Glenoid IRIS was also used 5 times on the same artificial cadaver. This constitutes a sample size of n=5 for each device version in the comparative functional test.
• Data Provenance: The data is from a prospective comparison study using an artificial cadaver. The country of origin is not specified but is implicitly within the scope of FDA submission, suggesting a U.S. or U.S.-compliant context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document mentions "A simulated use, artificial cadaver comparison test between the original and modified Glenoid IRIS was performed." and refers to "Artificial Cadaver Surgeon Evaluation (Validation)".
• It does not specify the number of experts (surgeons) or their qualifications who performed these evaluations. It only states that the "original Glenoid IRIS was used on an artificial training cadaver of a patient with severe glenoid retroversion five times" and "The modified Glenoid IRIS was also used on this same patient five times."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The comparison was based on "the mean version and inclination of the original and modified Glenoid IRIS" and "the amount of deviation from the planned guide pin location." This suggests a quantitative comparison against a predefined "planned guide pin location" (which implicitly serves as the ground truth), rather than an expert consensus adjudication on the outcome of each individual trial.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance evaluation focused on comparing the modified device's functionality directly against the predicate device's functionality in a simulated environment, not on human readers' improvement with or without AI assistance. The device is a "manual instrument system," implying human-in-the-loop by design.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study was not conducted or described. The device is a "patient specific manual instrument system," inherently designed for human-in-the-loop use. The evaluation involved a "surgeon evaluation" using the instruments.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the functional performance test (artificial cadaver surgeon evaluation), the ground truth was the "planned guide pin location." The deviation from this planned location was a key metric. This "planned location" would typically be established during the preoperative planning phase, likely based on surgical principles and potentially anatomical data, though the exact method of establishing this ground truth for the artificial cadaver is not detailed.
• For biocompatibility, the ground truth was established by standardized testing protocols (e.g., cytotoxicity, irritation, sensitization).
• For shipping/distribution durability, the ground truth involved passing predefined physical durability and temperature tolerance limits.

8. Sample Size for the Training Set

• The document describes a 510(k) submission, which is for demonstrating substantial equivalence to a predicate device. It primarily focuses on verification and validation of the modified device's performance against the predicate.
• There is no mention of a separate "training set" in the context of device performance evaluation. The device itself is a mechanical instrument system, not an AI or algorithm that would require a labelled dataset for training.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" applicable to this type of medical device (which is a manual instrument system), this question is not applicable.

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The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components.

The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) KI23122.

The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into 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. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, that contains text, images, and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan provided to the ordering surgeon.

The following information describes the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria with numerical targets. However, the non-clinical testing performed aims to demonstrate the device's ability to accurately perform its intended use and function, particularly in aiding accurate guide pin placement in total shoulder arthroplasty.

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