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The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.

The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• · Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection
• · Hip Arthroplasty

The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.

ARVIS® Surgical Navigation System is a computer-controlled surgical navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.

The subject device is the fundamentally unchanged predicate ARVIS® Surgical Navigation System. It is indicated for use in knee and hip arthroplasties. ARVIS® Surgical Navigation System combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging.

The navigation platform is identical to the predicate and uses the same electronic hardware, mounted on the surgeon's head and waist.

The subject device adds the capability to remotely activate graphical user interface (GUI) buttons and check boxes for the surgeon, who optionally can use this to work in conjunction with the current methods of gaze and voice control. The added capability is intended to provide a third alternate option for the surgeon to interact with the software.

ARVIS® Surqical Navigation System displays measurements as described in Performance Claims.

The provided text does not contain information about the acceptance criteria or a study proving that a new device meets such criteria. Instead, it describes a medical device submission (K243980) for the ARVIS Surgical Navigation System, which is stated to be "the fundamentally unchanged predicate ARVIS® Surgical Navigation System."

The key takeaway is that this submission is for a device that is essentially the same as a previously cleared device (K203115), with only a minor technological difference: the addition of a remote activation capability for GUI buttons and checkboxes via a tablet device.

Therefore, the document explicitly states:

• "Clinical testing was not required to demonstrate substantial equivalence."
• "The performance data provided in this submission demonstrate that ARVIS® Surgical Navigation System is as safe, effective, and performs as well as the predicate device."

Since this is a submission for a device that is largely identical to a predicate device, the typical extensive studies to establish acceptance criteria and prove performance for a new device are not detailed here. The submission relies on the established safety and effectiveness of the predicate device and verification/validation for the minor change.

Consequently, I cannot fill out the requested information regarding acceptance criteria, sample size, expert ground truth establishment, MRMC studies, or standalone performance for a new device's proving study, as such studies are not described in this document for K243980.

The document only mentions:

• Non-Clinical Tests: Software Verification and Validation.
• Conclusion: The device changes were verified and validated with existing well-established methods, demonstrating substantial equivalence to the previously cleared ARVIS Surgical Navigation System (K203115).

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The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified.

The 360CAS Knee is indicated for the following surgical procedures:

• · Any form of Total Knee Arthroplasty (TKA)
• · For conditions of the knee joint in which the use of computer assisted surgery may be appropriate

The 360CAS Hip is indicated for the following surgical procedures:

· Any form of Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used

· For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g., pointer, bone fixator(s)).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that "Sawbones mimicking patient's anatomy" were used for system accuracy testing and clinical workflow verification. However, the specific sample size (i.e., number of Sawbones or tests conducted) is not explicitly provided.

• Data Provenance: The tests were conducted using Sawbones, which are synthetic bone models, rather than actual patient data or cadavers. This suggests a bench-top testing environment, and thus the data is not tied to a specific country of origin in the same way clinical data would be. The testing is prospective in the sense that the device's performance was evaluated against a predefined protocol using these models.

3. 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 ground truth or their qualifications for the bench performance testing.

4. Adjudication method for the test set

The document does not describe any adjudication method for the test set. Given that the testing involved Sawbones and objective measurements against known accuracy standards, a formal adjudication process involving multiple human reviewers might not have been deemed necessary in the same way it would be for subjective clinical assessments.

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 comparative effectiveness study was done. The device (360CAS Knee and 360CAS Hip) is a computer-assisted surgical navigation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this device's reported evaluation. No effect size is mentioned.

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

Yes, the performance testing described appears to be a standalone (algorithm only) evaluation. The "System accuracy testing verifying the specified accuracy" and the "functional testing" assess the device's ability to perform its core functions and meet accuracy specifications independently of a human surgeon's real-time subjective assessment or intervention during the measurement process. The context is measuring the device's inherent accuracy and functionality.

7. The type of ground truth used

The ground truth used for performance testing was based on:

• Standardized test procedures and known measurements: For the ASTM accuracy testing (ASTM F2554-18 and ASTM F2554-22).
• Engineered precision/known values: For the "System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones." This implies that the 'true' or target measurements on the Sawbones were precisely known or set.

8. The sample size for the training set

The document does not provide information on a "training set" as this device is a navigation system and not a machine learning or AI-based diagnostic algorithm that typically undergoes a distinct training phase with a labeled dataset. While software verification and validation were conducted, these generally involve testing the implemented code against requirements, rather than training a model.

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

As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. The device instead relies on established mechanical and optical principles for navigation.

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The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.

The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.

The 360CAS Knee is indicated for the following surgical procedures:

• Total Knee Arthroplasty (TKA)
• For conditions of the knee joint in which the use of computer assisted surgery may be appropriate

The 360CAS Hip is indicated for the following surgical procedures:

• Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
• For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)).

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

The document primarily describes bench testing and cadaveric laboratory testing. Specific sample sizes for each test are not explicitly provided, but the types of materials used are:

• ASTM accuracy testing: Not specified, but uses a standardized test procedure according to ASTM F2554-18.
• System accuracy testing: Sawbones mimicking patient's anatomy.
• Clinical accuracy testing: Not specified, but states "in a cadaveric laboratory."
• Clinical workflow testing: Sawbones mimicking the patient's anatomy and cadaver laboratory.

The data provenance is from laboratory and cadaveric studies, not real-world patient data. The country of origin of the data is not explicitly stated, but the applicant company is located in Australia.

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 document describes verification and validation activities but does not detail how ground truth was established for these tests or the experts involved.

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

This information is not provided in the document. The document describes accuracy and workflow testing but does not mention any adjudication method for establishing ground truth or evaluating disagreements.

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 comparative effectiveness study was done. The device is a surgical navigation system, and the performance testing focuses on its accuracy and functionality, not its impact on human reader performance. No AI-assistance claims are made that would necessitate such a study.

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

Yes, standalone performance testing was done for the device's accuracy. The "System Accuracy" and "Clinical Accuracy" testing (translational and rotational error) are examples of standalone performance evaluations for the navigation system's output. The entire performance data section (bench testing, software V&V) implicitly describes standalone performance, as it assesses the device's inherent characteristics. The design of the device as a "planning and intraoperative guidance system" suggests it assists a human surgeon, but the accuracy metrics are for the system itself.

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

The ground truth for the performance testing appears to be based on:

• Standardized test procedures and physical measurements: ASTM F2554-18 for spatial tracking accuracy.
• Engineered or known physical values: Sawbones mimicking patient anatomy and cadaveric laboratories are used to assess the device's ability to measure and guide with specified accuracy (±2mm and ±1°). The "specified accuracy" itself serves as the benchmark for evaluation.

8. The sample size for the training set

This information is not applicable/not provided. The document describes a "stereotaxic surgical navigation system" and "optical tracking technology." While it includes "360CAS navigation software," it does not explicitly mention machine learning or AI models that would require a distinct "training set" in the context of deep learning. The software verification and validation, along with functional testing, imply that the software's performance was evaluated against its design specifications, not through a machine learning training/validation split.

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

This information is not applicable/not provided as there is no mention of a machine learning training set. The software's "ground truth" would be its design requirements and specifications, validated through standard software V&V processes and functional testing.

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360KS Implant Positioning System (IPS) is intended for use as patient-specific surgical planning software to aid orthopaedic surgeons in selection, sizing and placement of knee implant components (femur, tibia and patella implants) provided that the required anatomical landmarks of the knee can be identified on pre-operative CT or MRI scans in patients requiring total knee arthroplasty.

360KS IPS is indicated for use with OMNI Life Science Apex Knee System (#K060192, #K073602, #K080842) and Corin Unity Total Knee System (#K113060).

360KS Implant Positioning System (project name KicoCAD) is a medical device consisting of a software application that provides patient-specific pre-operative surgical planning to assist in the positioning of knee implant components (femur, tibia and patella implants) with compatible knee systems (OMNI Life Science Apex Knee System (#K060192, #K073602, #K080842) and Corin Unity Total Knee System (#K113060)) for total knee arthroplasty.

The software is designed to assist qualified medical professionals with implant component placement, orientation, positioning and size selection. 360KS Implant Positioning System uses a Graphical User Interface (GUI), where any input provided by the user will provide visual feedback reflecting the input provided. Pre-operative plans are available for the femur, tibia and patella.

360KS Implant Positioning System (360KS IPS) requires access to pre-processed patient images (CT or MRI scan) to display three-dimensional images. Pre-processing is done by the engineering team of Kico Knee Innovation Company using Scan IP (510(k) accession number: K142779) to generate a threedimensional bone model and landmarks. The bone model and landmarks are then imported into 360KS IPS and Production Engineers of Kico Knee Innovation Company apply the referring surgeon's prescription for sizing and placement of femoral, tibia and patella components to generate a surgical plan. The process of landmarking and surgical plan creation both have independent QC steps. Once the plan is complete and all QC steps have passed, it is uploaded to the cloud and made available to the referring surgeon. The referring surgeon can then view and modify the plan on their own installation of 360KS Implant Position System.

The 360KS Implant Positioning System is developed within the Integrated Development Environment (IDE) of Visual Studio Professional. The software is written in C# (C Sharp) using .NET framework target version 4.5 in Windows Operating System (OS). 360KS Implant Positioning System is recommended to run on a Windows 7 PC with 2.4 GHz or faster intel Core i5-6300 processor for best performance. The 360KS Implant Positioning System requires 4GB of RAM and a DirectX 9 graphics device with WDDM 1.0 or higher driver. The application requires 10GB of available disk space and the visual display resolution should be set to 1920x1080. An internet connection is also required.

The intended users are production trained engineers and trained orthopaedic surgeons who have experience in total knee replacement. To ensure correct user operation of the software, 360KS Implant Positioning System incorporates simple UI design to make the software more intuitive.

Creation of patient specific guides from the surgical plan is neither part of this device nor submission.

The provided text describes the 360KS Implant Positioning System (IPS), a software application for pre-operative surgical planning in total knee arthroplasty. Here is an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study to Prove Acceptance Criteria

The document explicitly states that non-clinical testing in the form of software verification and validation was performed to assess the safety and effectiveness of the device.

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

• Test Set Size: Not explicitly stated. The document mentions "Software verification and validation testing were conducted" and "Testing included both system and unit level." However, the exact number of test cases or "samples" (in the context of software testing, this refers to test cases rather than patient data) used is not provided.
• Data Provenance: Not applicable in the traditional sense of patient data provenance, as the testing described is software verification and validation, not clinical trials with patient data.

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

• This information is not provided. The document focuses on software verification and validation. While the software aids surgeons, the testing described isn't about expert performance to establish ground truth for a diagnostic task.

3. Adjudication method for the test set:

• This information is not provided and is generally not applicable to software verification and validation testing, which typically involves comparing software output against predefined specifications or expected outcomes.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states under "Clinical Testing": "This section does not apply. Clinical testing is not required for this Traditional 510(k) device." This indicates that no studies involving human readers, with or without AI assistance, were conducted for regulatory submission.

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

• Yes, a form of standalone performance assessment was done in the context of software verification and validation. The "Software Verification and Validation Testing" and "Non-Clinical Testing" sections refer to assessing the device's accuracy and performance against specifications and intended functionality. This is essentially an assessment of the algorithm's performance in isolation from a human user, verifying that the software functions as designed. The software itself is the "device," and its standalone performance was evaluated through V&V.

6. The type of ground truth used:

• For software verification and validation, the "ground truth" would be established by the software requirements specifications, design documents, and expected outputs based on those specifications. It's not clinical "expert consensus, pathology, or outcomes data" in this context. The document mentions that the process of landmarking and surgical plan creation both have "independent QC steps," which would contribute to establishing the correctness of the software's output against defined standards.

7. The sample size for the training set:

• This information is not provided. The document does not describe the use of machine learning or AI models in a way that would require a "training set" in the traditional sense of data used to train an algorithm. The 360KS IPS uses an existing 510(k) cleared software (Scan IP, K142779) for pre-processing to generate 3D bone models and landmarks, and the core device then allows for surgical planning based on these models. The development appears to be based on traditional software engineering principles rather than a data-driven machine learning approach requiring a training set.

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

• This information is not provided and is not applicable given that no "training set" for a machine learning model is mentioned or implied.

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