(206 days)
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spationing 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 3D or 2D image.
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.
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, Drape, Marker Ball, Patient Marker, Clamp, Adapter, Pin, Pin vise, Slide Hammer, Marker Driver, Detector calibrator, Dilator, Serration-tip dilator, Bur, Awl, Probe, Lenke probe, Tapper, Stylet tapper, Screwdriver, Instrument container.
The provided text describes the CUVIS-spine device, a robotic-assisted pedicle screw placement system. However, it does not contain specific acceptance criteria or details of a study demonstrating that the device meets those criteria, particularly regarding clinical performance metrics like accuracy measurements, clinical outcomes, or human reader effectiveness.
The document primarily focuses on:
- Substantial Equivalence: Comparing the CUVIS-spine to predicate devices (CUVIS-spine K201569 and Excelsius GPS™ K171651) based on technical characteristics, indications for use, and general device descriptions.
- Non-Clinical Tests: Mentioning that pose accuracy and repeatability were tested, and a cadaveric study was performed. It also lists the consensus standards used for biocompatibility, electrical safety, electromagnetic compatibility, risk management, usability, and software validation (including cybersecurity).
Therefore, I cannot populate the table or provide detailed answers to most of your questions based on the input text. The information needed to describe acceptance criteria and a study proving the device meets them (e.g., specific accuracy metrics, clinical data, sample sizes for test sets, ground truth establishment, or human reader improvement) is not present.
Here's what can be inferred or stated based on the given text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specific metrics are NOT provided in the document) | Reported Device Performance (Specific metrics are NOT provided in the document) |
|---|---|
| Accuracy verification on anatomical landmarks: (No specific metric, e.g., ±X mm deviation, is stated) | "Yes" (Indicates that accuracy verification was performed, but no quantitative results are given.) |
| Pose accuracy: (No specific metric is stated) | "tested and validated" (No quantitative results are given.) |
| Repeatability: (No specific metric is stated) | "tested and validated" (No quantitative results are given.) |
| Biocompatibility: (No specific metric is stated beyond adherence to standards) | "evaluated according to the FDA-recognized consensus standard, ISO 10993-5" |
| "evaluated according to the FDA-recognized consensus standard, ISO 10993-10" | |
| Basic safety and essential performance: (No specific metric is stated beyond adherence to standards) | "tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1" |
| Effect to the device by electromagnetic disturbances: (No specific metric is stated beyond adherence to standards) | "tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2" |
| Software validation (Level of Concern): Functionality, Cybersecurity | "MAJOR" level of concern, "verified Cybersecurity control and management as recommended in FDA." |
Missing Information for a Comprehensive Answer:
- Quantitative Acceptance Criteria: The document states that accuracy, pose accuracy, and repeatability were tested, but it does not define the specific numerical thresholds for these criteria (e.g., "accuracy must be within 1.0 mm").
- Quantitative Device Performance: Similarly, it does not report the actual measured performance values for accuracy, pose accuracy, or repeatability. It only states they were "tested and validated."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "cadaveric study" for the proposed device but does not state the sample size (e.g., number of cadavers, number of pedicles analyzed).
- Data Provenance: The document does not specify the country of origin of the cadaveric study or any other test data. It indicates the study was "cadaveric," implying it's a prospective experimental study, but details are lacking.
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 document.
4. Adjudication method for the test set
- This information is not provided in the document.
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
- A MRMC comparative effectiveness study is not mentioned in the document. The device is a robotic-assisted surgical system, not an AI diagnostic imaging tool that typically involves human reader performance studies in that context. The focus is on the robot's ability to aid surgeons in instrument placement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies that "Pose accuracy and Repeatability of the CUVIS-spine were tested and validated," which would constitute standalone technical performance testing of the robotic system itself, independent of a human surgeon's real-time interaction beyond initial setup and guidance. However, no specific details or results are provided to elaborate on this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the cadaveric study, the "ground truth" for pedicle screw placement accuracy would typically be established through post-procedure imaging (e.g., CT scans) quantitatively analyzed against the planned trajectory or anatomical landmarks. However, the document does not explicitly state how ground truth was established for the cadaveric study or the accuracy verification.
8. The sample size for the training set
- This information is not provided in the document. The document describes a robotic system, not a machine learning model, so a "training set" in the typical ML sense might not be applicable or explicitly mentioned here.
9. How the ground truth for the training set was established
- This information is not provided in the document, as it does not discuss a training set.
§ 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).