Search Results

The SambaScrew 3D SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SambaScrew 3D SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws of various lengths featuring multiple fenestrations along the shaft. The 11mm cannulated screw features a tapered proximal end and dual-pitch threads while the 12mm cannulated screw features a single pitch thread on the proximal and distal ends. The SambaScrews are constructed from medicalgrade titanium alloy (Ti-6AI-4V ELI). The 11mm and 12mm SambaScrews are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. SambaScrew allows for packing of autograft and allograft materials.

The document provided does not describe a study involving acceptance criteria and device performance in the context of a diagnostic or AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "SambaScrew 3D SI Fusion System," which is a surgical implant.

The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant, which is evaluated through physical tests rather than clinical study outcomes. The "study" mentioned is a series of non-clinical mechanical tests comparing the device to predicate devices.

Therefore, many of the requested categories (like sample size for test set, data provenance, expert qualifications for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a summary of the available information:

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

The document describes mechanical performance testing but does not provide specific acceptance criteria values or detailed reported performance data in a comparative table for each test type. It merely states that the tests were conducted according to ASTM standards to demonstrate substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance: Not applicable. These were mechanical tests on physical implants, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is determined by physical measurements against established standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.

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: Not applicable. This is a surgical implant, not an AI-powered diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical implant.

7. The type of ground truth used: The "ground truth" for the performance evaluation consisted of established mechanical test standards (ASTM F2193-18a and ASTM F543-17) and comparative performance with legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device