(263 days)
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.
Acceptance Criteria and Study for Paradigm System
The Paradigm System, a stereotaxic image guidance system, underwent verification and validation activities to assure it meets performance requirements. The provided documentation highlights general functional and safety testing as well as cadaveric model studies. This response compiles the stated information regarding acceptance criteria and the supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics for the Paradigm System. Instead, it broadly states that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions." The document lists the types of testing performed and the standards used, implying that the acceptance criteria are met by demonstrating compliance with these tests and standards.
The studies mentioned are:
- Non-Clinical Hardware, Software, and Instrumentation Verification Tests
- Non-Clinical Design Validation conducted in Cadaveric Model
- Cadaveric Simulated Workflow Study Assessing Usability
- Compliance Conformity Assessments
The conclusion states: "Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness." This indicates that the device's performance was deemed acceptable relative to established safety and effectiveness benchmarks, likely derived from the predicate device and relevant standards.
2. Sample Size for Test Set and Data Provenance
The document states that a "Non-Clinical Design Validation conducted in Cadaveric Model" and a "Cadaveric Simulated Workflow Study Assessing Usability" were performed for testing.
- Sample Size: The exact sample size (number of cadavers or specific test cases) used for these cadaveric studies is not specified in the provided text.
- Data Provenance: The cadaveric studies are inherently prospective in their design, as they involve performing procedures on the cadavers in a controlled setting for the purpose of testing. The country of origin of the cadaveric data is not specified.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The mention of "Cadaveric Simulated Workflow Study Assessing Usability" suggests involvement of users (e.g., surgeons) in the evaluation, but details on ground truth establishment are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. Standalone Performance Study
The document refers to "Non-Clinical Hardware, Software, and Instrumentation Verification Tests" and "Non-Clinical Design Validation conducted in Cadaveric Model." While these indicate testing of the algorithm and system, it is not explicitly stated whether a "standalone (i.e., algorithm only without human-in-the-loop performance)" study was conducted. The nature of a stereotaxic image guidance system inherently involves integration with human procedural steps.
7. Type of Ground Truth Used
For the cadaveric studies, the specific type of ground truth used (e.g., expert consensus on target accuracy, direct measurement, pathology, outcomes data) is not explicitly stated. Given the device's purpose for spatial positioning and orientation, ground truth would likely involve highly accurate measurements of instrument tip position relative to anatomical targets within the cadaveric model, verified by a gold standard measurement technique.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set for any underlying algorithms within the Paradigm System. The description of the device's principle of operation mentions "fuses high-resolution, real-time camera imaging... with medical imagery (such as CT)" and "Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae," implying that algorithms are trained on such data.
9. How Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established.
In summary, while the document confirms that various tests were conducted to ensure the safety and effectiveness of the Paradigm System, detailed information regarding specific performance metrics, sample sizes for test and training data, expert qualifications, and ground truth establishment methods is largely absent in 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).