(271 days)
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.
| Item | Description | Purpose |
|---|---|---|
| 1 | Eyepiece Assembly | Houses display, speakers, cameras, and other sensors. |
| 2 | Belt Pack | System power management. Houses the External Battery |
| and Computer module. | ||
| 3 | Computer Module | Runs the ARVIS® Application Software. |
| 4 | External Battery | Removable/swappable. Provides power to the Eyepiece |
| Assembly and the Computer module. | ||
| 5 | Eyepiece Cable | Connects Eyepiece to the Belt Pack. |
| --- | ---------------------------- | ----------------------------------------------------------------------------------------------------------------- |
| 6 | Battery Charging | |
| System | Charges External Battery when system is not in use. | |
| Intended to be used outside the operating room. | ||
| 9 | Instrument Set | Surgical tools, including trackers, mounts, adapters, etc. |
| that are required to perform surgical procedures. |
The ARVIS® Surgical Navigation System has the following acceptance criteria and study data:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cleaning process Validation: The ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use. | Cleaning process Validation: The ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use. |
| Sterilization Validation: | Sterilization Validation: |
| a. The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared reprocessing equipment. | a. The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared reprocessing equipment. |
| b. The reprocessing instructions are technically feasible for implementation by users. | b. The reprocessing instructions are technically feasible for implementation by users. |
| c. The sterilization process has been validated to attain a sterility assurance level (SAL) of 10-6. | c. The sterilization process has been validated to attain a sterility assurance level (SAL) of 10-6. |
| Software Verification and Validation Testing: | Software Verification and Validation Testing: |
| 1) All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly. | 1) All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly. |
| 2) All Risk Mitigations to be implemented in software were implemented and operated correctly. | 2) All Risk Mitigations to be implemented in software were implemented and operated correctly. |
| 3) The software conforms with the user needs and intended uses of the ARVIS® device. | 3) The software conforms with the user needs and intended uses of the ARVIS® device. |
| Electromagnetic Compatibility (EMC) testing: The ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility. | Electromagnetic Compatibility (EMC) testing: The ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility. |
| Electrical Safety testing: The ARVIS® System is compliant with applicable Standards for Electrical Safety. | Electrical Safety testing: The ARVIS® System is compliant with applicable Standards for Electrical Safety. |
| Safety and Performance Bench Testing: The ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance. | Safety and Performance Bench Testing: The ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance. |
| Simulated Clinical Validation Testing: The particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System, including validation of user requirements and navigation accuracy. | Simulated Clinical Validation Testing: The particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System, including validation of user requirements and navigation accuracy. |
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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).