Search Results

The Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.

The Stryker Discmonitor is a sterile, disposable device used to inject fluid into the intervertebral disc nucleus during discography procedures. The device will measure of the fluid and display it in a digital format. The physician can control the pressure of the fluid and the rate of injection using the device. As additional information, the device will also measure the volume of fluid injected into the disc and the amount of time each disc is pressurized. The device will save the pressure and volume over time during the procedure. The physician will be able to manually save key data points for each disc. These points may be recalled later and are highlighted on the printout in both a graphic and tabular format.

The provided text is a 510(k) premarket notification for the Stryker Discmonitor, a device used to inject fluid and monitor pressure during discography procedures. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information on acceptance criteria, a specific study proving device performance against those criteria, or details regarding the methodologies of such a study (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, or training set details).

Based on the provided text, the following points can be addressed:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided document. The document states: "The Stryker Discmonitor does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Discmonitor is substantially equivalent to these existing devices." This indicates a focus on substantial equivalence rather than a detailed performance study against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not available in the provided 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:

This information is not available in the provided document. The device described (Stryker Discmonitor) is a physical instrument for fluid injection and pressure monitoring, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study for evaluating human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not available in the provided document. The device is a physical instrument, and the concept of "standalone algorithm performance" does not directly apply in the same way it would for AI-based diagnostic software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not available in the provided document.

8. The sample size for the training set:

This information is not available in the provided document.

9. How the ground truth for the training set was established:

This information is not available in the provided document.

Ask a specific question about this device