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The SYMBIS Surgical System is a computer-controlled electromechanical arm. The arm is performed by the neurosurgeon. It is intended to be used in the spatial positioning and orientation of a biopsy instrument guide.

Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle.

It is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument guide. The system is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System consists of the a Surgeon Console, Surgical Cart, Manipulator, Robot Control Cabinet (RCC), Vision System, Platform Room Integration Kit and System Software.

The Manipulator is a master/slave robot configured with either a left arm or a right arm is mounted to the Surgical Cart. The Surgical Cart is used to transport the Manipulator to and from the operating room, as well as serve as a stationary platform for robotic surgery. The Surgical Cart has an onboard immobilization system to prevent horizontal movement when positioned for surgery. The Instrument Guide is attached to the draped Manipulator and is used by the surgeon to guide the trajectory of a stereotactic instrument (e.g. Biopsy Needle). The Manipulator has six (6) degrees of freedom (DOF). The SYMBIS System provides tremor filtering and motion scaling while the surgeon positions the Manipulator and Instrument Guide to the target position. A Vision System mounted to the Surgical Cart provides the surgeon with a high definition, three-dimensional view of the patient, surgical site, and Manipulator.

The Surgeon Console provides the surgeon with workstation console from which the surgeon controls the Manipulator. The Surgeon Console is located in the operating room. The surgeon, seated at the Surgeon Console, controls all movements of the Manipulator with a hand controller and foot pedal. The upper and middle displays on the Surgeon Console are medical grade, high definition monitors, and the middle monitor is capable of displaying 3 dimensional (3D) images The upper display provides the video output from a third-party navigation system (i.e. Medtronic Stealth station s7/i7). The middle display provides the 3D video output from the field camera, to provide situational awareness to the surgeon when moving the robot near the patient, surgical site, and OR staff. The video from the Vision System, along with the video from the third-party navigation system, is used by the surgeon to manipulate the Instrument Guide to the entry position.

The Robot Control Cabinet (RCC) is an electronics rack and contains to operate the Surgical Cart, Manipulator and Surgeon Console. It is situated in the hospital's equipment room, adjacent to the surgical suite. The RCC includes the supporting electronic, power supply, and computers for the system.

The platform room integration kit includes motor drivers to run the Manipulator, an OR Pendant with an E-Stop, cable interface mounting plates and system integration cables.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for SYMBIS Surgical System

1. Table of Acceptance Criteria and Reported Device Performance

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 primarily describes bench testing for design verification and validation, as well as a summative human factors validation study.

• Design Verification and Validation (Bench Testing): No specific "test set" sample size in terms of patient data is mentioned for these tests. The testing focuses on compliance with standards (e.g., electrical safety, software, biocompatibility, sterilization) and functional performance of the device components. This is not patient data; it's device performance testing.
• Human Factors Evaluation: Fifteen neurosurgeons participated in this study.
• Data Provenance: The document does not specify the country of origin for any data beyond listing the submitter (IMRIS Inc.) as being from Minnetonka, MN, USA. There is no mention of retrospective or prospective data in the context of patient studies. The studies described are bench tests and a simulated human factors study, not clinical trials with 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)

• For the Human Factors Evaluation, 15 neurosurgeons participated. Their qualifications are stated as "neurosurgeons," but no further details (e.g., years of experience) are provided. Their role was to participate in a simulated surgical procedure to assess use-safety, effectiveness, and ease of use, not to establish ground truth for a test set in the traditional sense of medical image interpretation.

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

• No adjudication method is mentioned. The human factors study involved neurosurgeons operating the system, and their feedback/performance was assessed, not a consensus interpretation of medical data.
• For the bench testing, conformity to engineering specifications and standards served as the "ground truth," not expert adjudication.

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 or mentioned in the document. The device is a computer-controlled electromechanical arm for surgical guidance, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" in the typical sense of MRMC studies. It's a robotic assistance system, not an AI interpretation system.

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

• This question is not directly applicable to the SYMBIS Surgical System as described. The system is explicitly designed for "human-in-the-loop" performance, where the "arm is performed by the neurosurgeon" and "the surgeon controls all movements of the Manipulator." There is no mention of a standalone algorithm-only mode or performance evaluation.

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

• For design verification and validation, the ground truth was established by adherence to product specifications and recognized industry standards (e.g., IEC, ISO, AAMI). For example, a specified application accuracy of "<2 mm" is a measurable metric against which the device's performance is compared.
• For the human factors evaluation, the "ground truth" was the assessment of "use-safety and effectiveness of the system, identify and assess any hazards resulting from implemented mitigations and evaluate ease of use" by the participating neurosurgeons in a simulated environment. This is less about a single patient-specific ground truth (like a pathology report) and more about overall system usability and safety performance.

8. The sample size for the training set

• No training set is mentioned as this device is not a machine learning or AI-based diagnostic tool that typically requires a training set of data. It is a robotic surgical assistance device whose control software's "training" would be part of its engineering design and development, rather than data-driven machine learning.

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

• Not applicable, as no training set (in the context of machine learning) is referenced for this device.

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