Search Results

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 document is a 510(k) premarket notification acceptance letter from the FDA for the Paradigm System. It primarily discusses the device's substantial equivalence to a predicate device (also named Paradigm System) and lists relevant regulations and testing standards.

Crucially, this document does NOT contain details about the acceptance criteria and the specific study performance that proves the device meets those criteria. It mentions "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists some standards used for testing (e.g., IEC 60601-1, ISO 14971, ASTM F2554-22 for positional accuracy). However, it does not provide the actual quantitative acceptance criteria or the results from these studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. While ASTM F2554-22 (Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems) is mentioned, the specific acceptance thresholds and the measured positional accuracy of the Paradigm System are not detailed.
2. Sample size used for the test set and the data provenance: The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model" but does not specify the sample size (number of cadavers, number of anatomical sites, etc.) or the provenance of the cadavers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the study details are missing.
4. Adjudication method for the test set: Not applicable as the study details are missing.
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: The device is a stereotaxic image guidance system, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers. The document does not mention any AI components that would assist human readers in image interpretation. Its function is to guide surgical instruments, fusing real-time camera imaging with medical imagery (CT) and surgical navigation data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a system for surgical guidance, implying a human (surgeon) is always in the loop. It does not mention a standalone algorithm evaluation.
7. The type of ground truth used: For positional accuracy, the ground truth would typically be established by highly accurate measurement systems (e.g., optical tracking systems, CMMs) in a controlled environment, not expert consensus or pathology in the traditional sense of diagnostic AI. The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model," which suggests physical measurements against a known fiducial or planned trajectory.
8. The sample size for the training set: Not applicable, as detailed information on any AI/machine learning components or their training is not provided. The system uses "preoperative imaging segmentation" but doesn't elaborate on whether this involves deep learning requiring a dedicated training set.
9. How the ground truth for the training set was established: Not applicable, as information on training sets is missing.

In summary, the provided FDA letter confirms the clearance of the Paradigm System based on substantial equivalence but does not disclose the detailed performance study results or the specific acceptance criteria met by the device. These details would typically be found in the full 510(k) submission, which is not included here.

Ask a specific question about this device