(342 days)
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments.
The CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container.
The provided text describes the CUVIS-spine device, a robotic-assisted pedicle screw placement system. It includes information on its regulatory classification, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or an explicit study proving that the device meets defined acceptance criteria in the format requested.
The Performance Data section mentions non-clinical tests for "pose accuracy and repeatability" and a "cadaveric study" for robotic-assisted pedicle screw placement. It also touches on biocompatibility, electromagnetic compatibility, electrical safety, risk management, and usability. However, it does not provide details on the acceptance criteria for these tests, nor the results in a quantified manner that directly addresses the prompt's request for a table of acceptance criteria and reported device performance.
Therefore, I cannot fully complete the requested table or describe a detailed acceptance criterion study based on the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pose Accuracy | "tested and validated" (No specific numerical criterion or reported value provided) |
| Repeatability | "tested and validated" (No specific numerical criterion or reported value provided) |
| Biocompatibility (in vitro cytotoxicity) | "tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-5." (No specific result provided, only adherence to standard) |
| Biocompatibility (irritation, skin sensitization, intracutaneous reactivity) | "tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-10." (No specific result provided, only adherence to standard) |
| Electrical Safety | "tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1." (No specific result provided, only adherence to standard) |
| Electromagnetic Compatibility | "tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2." (No specific result provided, only adherence to standard) |
| Risk Management | "recorded by referring to ISO 14971." (No specific outcome or acceptance level provided) |
| Usability | "documented by referring to IEC 60601-1-6." (No specific outcome or acceptance level provided) |
| Robotic-assisted pedicle screw placement (cadaveric study) | "performed" (No specific performance metrics like accuracy, success rate, or error margins, nor acceptance criteria for these, are provided) |
2. Sample size used for the test set and the data provenance
- Sample size for non-clinical tests (pose accuracy, repeatability): Not specified.
- Sample size for cadaveric study: Not specified (referred to as "A cadaveric study").
- Data provenance: Not specified. The studies are referred to generally as "non-clinical tests" and "A cadaveric study," without details on the origin or nature (retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The document refers to "testing and validation" and a "cadaveric study" but does not detail the methodology for establishing ground truth or the involvement/qualifications of experts.
4. Adjudication method for the test set
- This information is not provided in the text.
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
- This information is not provided in the text. The CUVIS-spine is described as a robotic-assisted system for surgical instrument guidance, not an AI software for interpretation by human readers. Therefore, an MRMC study related to human reading improvement with AI assistance would not be applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies a standalone performance component for the robotic system in its "pose accuracy and repeatability" tests and the cadaveric study, as these would assess the device's technical performance. However, it does not explicitly state "standalone performance study" or provide results that isolate the algorithm's performance without human interaction during operation. The system's indication for use is "as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons," implying human interaction is part of its intended use.
7. The type of ground truth used
- For the cadaveric study, the implied ground truth would likely be based on post-insertion imaging (e.g., CT scans) or physical dissection to verify screw placement accuracy relative to the surgical plan. However, this is not explicitly stated.
- For pose accuracy and repeatability, the ground truth would be precise measurements of the robotic arm's position and orientation using metrology equipment.
- For biocompatibility and electrical safety/EMC, the "ground truth" is adherence to the specified ISO/IEC consensus standards.
8. The sample size for the training set
- This information is not provided in the text. The CUVIS-spine is a robotic system, not explicitly an AI model trained on a dataset of images in the conventional sense for diagnostic AI. While it uses software, the text does not describe a training set for machine learning.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned for a machine learning model, this information is not applicable based on the provided text.
§ 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).