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510(k) Data Aggregation
(90 days)
The Cannulated PsiFGuard is an accessory to systems intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. It is indicated for use during sacroiliac joint guidewire placement to provide feedback to the surgeon via visual and audible alerts that indicate a change in conductivity at the tip of the probe and may indicate contact of the tip with bone and possible cortex perforation.
The Cannulated PsiFGuard is a device that assists surgeons to place a guidewire in the sacroiliac joint during posterior sacroiliac fusion surgery. The Cannulated PsiFGuard device serves to alert the surgeons prior to a possible cortex perforation during quidewire placement, by analyzing the electrical conductivity of the surrounding tissues. The Cannulated PsiFGuard consists of a stainless steel needle component and electronic handle (DSG Handle or the DSG Connect Handle).
The Cannulated PsiFGuard has exactly the same principles of operation as the previously cleared systems, i.e. the tip of the instrument simultaneously penetrates the tissue for guidewire placement and senses possible cortex perforation or contact with bone. The devices then provide a visual and audible feedback to the surgeon to indicate changes in conductivity associated with possible bone perforation. If the DSG Connect handle is used, the device also allows for the signal generated by the device to be transferred to a tablet, to visually reproduce the audio signal over time.
The provided document does not contain detailed information about the acceptance criteria and a specific study that proves the device meets those criteria for the Cannulated PsiFGuard. The "Performance Data" section mentions a cadaver study and mechanical performance evaluation, but it lacks the specific metrics, sample sizes, and detailed outcomes that would constitute clear acceptance criteria and proof of meeting them.
However, based on the limited information available and inferences from typical FDA submissions, here's a structured response addressing the requested points:
Acceptance Criteria and Device Performance for Cannulated PsiFGuard
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred) | Reported Device Performance (From document) |
|---|---|
| Guidewire placement accuracy (in sacroiliac joint fusion procedures with the device vs. standard technique) | Demonstrated in a cadaver study. (Specific metrics of accuracy, e.g., % accurate placement, error margin, were not provided). |
| Ability to measure tissue impedance and provide alerts | Demonstrated in a cadaver study. (Specific sensitivity/specificity or other performance metrics were not provided). |
| Mechanical robustness under cantilever bending loads | Withstood mechanical action induced by sacroiliac joint guidewire placement. (Specific thresholds or pass/fail criteria were not provided). |
| Functionality as intended | "In all instances, the Cannulated PsiFGuard functioned as intended and the performance observed was as expected." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions a "cadaver study" but does not specify the number of cadavers or individual guidewire placements analyzed.
- Data Provenance: Prospective (cadaveric study setting). The country of origin is not specified, but the applicant (SpineGuard S.A.) is based in Vincennes, France.
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 multi-reader multi-case (MRMC) comparative effectiveness study involving human readers/surgeons and AI assistance is not described in the document. The device provides "visual and audible alerts" to a surgeon, but the study described is a cadaver study for device performance, not a study evaluating human performance with and without the device's assistance. The device is not an AI/Software as a Medical Device (SaMD) in the typical sense that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is explicitly designed to provide real-time feedback (visual and audible alerts) to a surgeon during guidewire placement. Therefore, it's an "in-the-loop" device, and a standalone algorithm-only performance assessment would not be applicable or relevant to its intended use. The cadaver study investigated the device's ability to measure impedance and provide alerts, which is its core standalone function within the human-assisted workflow.
7. The type of ground truth used
For the cadaver study:
- For guidewire placement accuracy: Likely determined by imaging (e.g., fluoroscopy, CT scans) after placement, or direct anatomical visualization, to verify correct guidewire position relative to the sacroiliac joint.
- For cortex perforation/bone contact detection: Likely determined by direct visual inspection during disarticulation/dissection of the cadaveric specimens, or confirmation via imaging, combined with the device's alert.
8. The sample size for the training set
The document does not mention a training set in the context of device performance studies. The Cannulated PsiFGuard's principle of operation is based on established electrical conductivity sensing technology, as described by its reference device (K201454 Cannulated PediGuard with DSG Connect technology, SpineGuard S.A.). This suggests the core technology was already developed and potentially "trained" (in an engineering sense) or validated in prior devices, rather than requiring a new "training set" for a machine learning algorithm.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of this submission, this information is not applicable/not provided.
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