(524 days)
The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The Sinobot X1 device is a computer-aided, robotized image-guided interactive surgical system. The system integrates medical image processing technology with robotic surgery technology to assist the surgeon during brain surgeries. The system allows the surgeon to utilize the spatial positioning technology to pre-plan the instruments on medical images and provide stable, precise and reproducible guidance in accordance with the planning. The device consists of a robotic stand with a compact robotic arm and a touch screen. The robotic arm can attach to different types of instruments and be changed based on the intended surgical procedures. For different surgical procedures a biopsy needle, stimulation or recording electrode could be attached to the device.
The 3D Optical scanner is an optical device combined by a projector and a visible light camera. Which provide a high-resolution point cloud scanning of patients' facial skin surface in order to perform patient registration.
The provided text describes the Sinobot X1, a computer-aided, robotized image-guided interactive surgical system, and its substantial equivalence to a predicate device. Regarding acceptance criteria and the study proving it, the following information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the provided text. However, the accuracy testing results imply that the reported performance values are within an acceptable range for regulatory clearance (as the device received substantial equivalence). Given the context of a stereotaxic instrument for neurosurgery, high accuracy is paramount.
| Device Performance | Acceptance Criteria (Implied) | Reported Device Performance (Mean) | Standard Deviation | Confidence Interval at 99% Confidence Level |
|---|---|---|---|---|
| Positional accuracy [mm] | Needs to be sufficiently precise for neurosurgery, likely less than or equal to a few millimeters for safe and effective use. | 0.613 mm | 0.197 mm | 1.205 mm |
| Angular accuracy [degree] | Needs to be sufficiently precise for neurosurgery, likely less than or equal to a few degrees for safe and effective use. | 0.439 degrees | 0.241 degrees | 1.163 degrees |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the accuracy tests (positional and angular accuracy). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these specific tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the accuracy tests. These tests are typically conducted using precision measurement tools and phantoms, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable for the reported non-clinical accuracy tests as they are objective measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the Sinobot X1 based on the provided information. The study described focuses on non-clinical performance data (accuracy and safety testing) for device clearance, not on human-in-the-loop performance or comparative effectiveness against human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the accuracy tests (positional and angular) can be considered standalone performance assessments of the device's robotic and guidance capabilities. These tests evaluate the inherent precision of the system without direct human surgical intervention as part of the measurement.
7. The Type of Ground Truth Used
For the positional and angular accuracy tests, the ground truth would be established by highly precise metrology equipment or calibrated phantoms with known spatial and angular relationships. These are objective engineering measurements rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of the reported accuracy tests. These are non-clinical hardware/software performance validations, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned in relation to the reported performance evaluation.
§ 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).