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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 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
• · Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
• · Hip Arthroplasty

The ARVIS® Surgical Navigation System (ARVIS® System) is to be used by orthopedic surgeons and operating room staff who perform hip and knee arthroplasty.

The ARVIS® System uses cameras to measure locations and angles between trackers mounted on the patient and trackers mounted on surgical instruments. By prompting the user through a procedurespecific workflow to register the reference tracker to anatomic landmarks, the ARVIS® Application Software calculates and displays positions of the instruments relative to the patient's anatomy.

The Eyepiece Assembly contains stereo infrared (IR) tracking cameras, a color camera, a stereo display, IR illumination, and IR laser illuminator. The Eyepiece also includes a headlight. The Eyepiece communicates with the Belt Pack via a cable connection.

The Belt Pack houses the computer module, the battery, and the power management board. The Belt Pack supplies power to the eyepiece and computer module. The computer module runs the ARVIS® Application Software.

All system instructions, prompts, alerts, and outputs are displayed to the surgeon on the Eyepiece display. The ARVIS® System Eyepiece is worn on the surgeon's head via a surgical helmet. The ARVIS® Belt Pack is worn on the surgeon's belt or waistband. No electronic hardware is applied to the patient. The surgeon stands adjacent to the patient to operate. The ARVIS® Battery Charger is intended to be used outside the operating room.

The ARVIS® System comprises the major elements listed in Table 1.

The ARVIS® Surgical Navigation System has the following acceptance criteria and study data:

1. Acceptance Criteria and Reported Device Performance

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

The document indicates that "Simulated Clinical Validation Testing" was conducted in a "human cadaveric setting." However, it does not specify the sample size (number of cadavers or simulated cases) used for this test set, nor does it provide details on the country of origin or whether the cadaveric 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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the simulated clinical validation testing.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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 does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The testing focused on device performance and accuracy in a simulated clinical setting.

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

The "Simulated Clinical Validation Testing" involved validating "user requirements and navigation accuracy," suggesting human interaction with the system. While the "Safety and Performance Bench Testing" also assessed the system's performance specifications, it's not explicitly stated if a standalone, algorithm-only performance evaluation without any human-in-the-loop was performed. The device is a "Surgical Navigation System" which inherently implies human-in-the-loop operation.

7. The type of ground truth used

For the "Simulated Clinical Validation Testing," the ground truth was likely established through precise measurements or direct observation in the human cadaveric setting to assess navigation accuracy and fulfillment of user requirements. The document does not explicitly state the specific method for establishing this ground truth (e.g., highly accurate physical measurements, known anatomical landmarks).

8. The sample size for the training set

The document does not provide information about a training set since no clinical testing was performed for the determination of substantial equivalence (as stated in Section 9.2). The device is a surgical navigation system, and the provided tests focus on verification and validation of its components and overall system performance rather than an AI model that would require a distinct training set.

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

As no training set is mentioned or implied for an AI model, the method for establishing its ground truth is not applicable or described in this document.

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