(72 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.
The provided FDA 510(k) Clearance Letter for the Paradigm System (K250879) indicates substantial equivalence to a predicate device (K243258). While it mentions that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists various standards used in testing, it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.
The document primarily focuses on demonstrating substantial equivalence based on the device's intended use, indications for use, fundamental scientific technology, and technical characteristics being the same as the predicate. It states that "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," but does not present the granular data of what those performance, safety, and usability tests entailed or their quantitative outcomes against defined acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample sizes used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- If a standalone (algorithm only without human-in-the-loop performance) was done: Not specified.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not specified.
- How the ground truth for the training set was established: Not specified.
The provided document is a 510(k) clearance letter, which summarizes the FDA's finding of substantial equivalence based on information submitted by the manufacturer. It typically does not contain the detailed raw data, study designs, or complete results of every verification and validation test performed by the manufacturer. That detailed information would be found in the manufacturer's submission to the FDA, not in the clearance letter itself.
The document lists standards used, such as ASTM F2554-22 "Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems." This standard likely defines methods for measuring positional accuracy, which would be a key performance metric for a stereotaxic navigation system. However, the document does not report the specific results of applying this standard or the acceptance criteria for those results.
§ 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).