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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 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 CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.

The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.

The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.

The CAS PSI Shoulder consists of both software and hardware components and requires the patient to be radiologically scanned. The CAS PSI Shoulder has been developed with the fundamental goals to assist in pre-operative planning (using the CAS PSI Shoulder Software) and to accurately construct and transfer a pre-operative plan to orthopedic surgical procedures (using the CAS PSI Shoulder Hardware). The hardware (jigs and bone model) have features designed to mate with legally marketed instruments to aid in the implantation of legally marketed Class II implant devices. The hardware components are designed to mate with legally marketed instruments and thus indirectly aid in the placement of legally marketed implants. The software is developed in C++ programming language for a windows operating system. The hardware (jigs and bone guide) are made from biocompatible polyamide (Duraform) with press-fit 304 and 17-4 Stainless Steel components.

The provided text describes the "CAS PSI Shoulder" device, a surgical planning and instrument guidance system for shoulder replacement procedures. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria and a specific study proving the device meets those criteria.

Instead, it provides a general overview of non-clinical performance studies and a high-level conclusion.

Here's a breakdown of what can and cannot be extracted from the given text based on your request:

What can be extracted:

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

The document states: "Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy."

However, it does not provide a specific table of acceptance criteria nor quantified device performance metrics from these tests. It only lists the types of non-clinical studies conducted.

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 for any of the listed non-clinical studies.
• Data Provenance: Not specified for any of the listed non-clinical studies (e.g., country of origin, retrospective/prospective). The studies are listed as "Simulated Use Testing," "Cadaveric Testing," etc., implying laboratory or cadaver-based testing rather than clinical patient data.

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):

• This information is not provided in the document. The non-clinical studies (Simulated Use, Cadaveric) would likely involve internal experts or engineers evaluating performance, but their number and qualifications are not detailed.

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

• This information is not provided in the document.

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 or reported. The document focuses on non-clinical testing and states that "clinical data and conclusions were not needed to demonstrate substantial equivalence." The device assists in planning but the studies listed are not designed to measure human reader improvement with or without AI.

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

• The document describes "Software Verification and Validation" as one of the non-clinical studies. This would likely involve evaluating the algorithm's performance in a standalone capacity internally. However, specific metrics of its standalone performance (e.g., accuracy, precision) are not reported.

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

• For the non-clinical studies:
  • Simulated Use Testing & Cadaveric Testing: The ground truth would likely be based on established anatomical landmarks, surgical protocols, engineering specifications, and possibly measurements of implant or instrument placement accuracy against a predefined ideal.
  • Software Verification and Validation: Ground truth would be based on expected software output given specific inputs, adherence to design specifications, and computational accuracy.
• Specific methodologies for establishing ground truth are not detailed.

8. The sample size for the training set:

• Not applicable/Not provided. The document describes a "Software Verification and Validation" study and does not mention machine learning or AI in a way that suggests a distinct training set for an AI model. The software component aids in pre-operative planning, which is a rules-based or computational task rather than a traditional machine learning model requiring a training set in the context of this document.

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

• Not applicable/Not provided for the same reasons as point 8.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance studies (simulated use, cadaveric, biocompatibility, sterilization, dimensional stability, drop testing, and software verification/validation). It explicitly states that clinical data and conclusions were not needed. As such, it lacks the detailed performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods typically found in studies evaluating AI diagnostic or prognostic devices against specific acceptance criteria.

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