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iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.

The iSR'obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software features include multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

The iSR'obot Mona Lisa 2.0 is user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a needle or a probe, during image-guided diagnostic and interventional procedures involving the prostate gland in a clinical setting. The device displays the 2D live image feeds from commercially available ultrasound systems and constructs 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration.

The provided text for iSR'obot Mona Lisa 2.0 (K213411) focuses on demonstrating substantial equivalence to a predicate device and details non-clinical testing. It explicitly states, "There is no pre-market clinical investigation submitted for iSR'obot Mona Lisa 2.0." Therefore, there is no information available in this document regarding acceptance criteria for clinical performance, the results of a clinical study proving the device meets these criteria, or details related to human readers, sample sizes for test/training sets, or ground truth establishment in a clinical context.

However, the document does describe non-clinical system performance testing using phantoms. I can extract information related to those non-clinical tests.

Non-Clinical System Performance Testing (using phantom)

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The document only states that these tests were "conducted to demonstrate" the listed functionalities. It does not provide specific numerical results or quantitative acceptance thresholds for these non-clinical tests in the provided summary. A "Pass / Meets criteria implied" is inferred based on the submission being cleared and the statement that "successful verification and non-clinical testing" was performed.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size (Test Set): Not specified in the provided text. The tests were conducted using a "phantom."
• Data Provenance: The tests were non-clinical, using a "phantom." Therefore, there is no patient data provenance (country, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable for non-clinical phantom testing.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable for non-clinical phantom testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No. The document explicitly states, "There is no pre-market clinical investigation submitted for iSR'obot Mona Lisa 2.0."
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

• Was a standalone study done? Not explicitly mentioned as a separate formal study, but the "Non-clinical System Performance Testing" on a phantom would represent an algorithm/system-only performance test in a controlled environment, demonstrating the device's capabilities without direct human clinical intervention during the specified tasks (e.g., automated positioning accuracy). However, the device is marketed as "user-controlled, stereotaxic accessory intended to guide physicians," implying a human-in-the-loop for its clinical use.

7. Type of Ground Truth Used:

• Ground Truth Type: For the non-clinical phantom testing, the ground truth would typically be the precisely known or measured locations/trajectories within the phantom, established by engineering specifications, physical measurements, or other metrology techniques. The document refers to the system's "ability to accurately position the needle" and "adjustment... to compensate for the patient movement," which suggests a known target or reference from which accuracy/adjustment can be measured against.

8. Sample Size for the Training Set:

• Sample Size (Training Set): Not applicable or not specified in the provided text, as this document focuses on regulatory submission for a marketed device based on non-clinical testing and substantial equivalence, not detailing the development or training of specific AI components if they exist within the system beyond the mechanical guidance.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth Establishment (Training Set): Not applicable or not specified.

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iSR'obot Mona Lisa 1.0 is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third- party ultrasound machine and endorectal probe that supports B-Mode, and a thirdparty prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist. The patient is administered general anesthesia and placed in a lithotomy position.

The iSR'obot Mona Lisa 1.0 is able to display the 2D live image feeds from commercially available ultrasound systems and also construct 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements, and 2D/3D image registration. The device is a user-controlled, stereotaxic accessory intended to guide the urologist or physician in the planning and positioning of a needle during ultrasound-guided transperineal prostate procedures such as biopsies in the operating room.

The iSR'obot Mona Lisa 1.0 comprises a workstation, robotic navigation module (comprising of robotic arm and bed rail stabilizer), and disposables.

The Biobot Surgical Pte Ltd iSR'obot Mona Lisa 1.0 device did not

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