Search Results

When used as an intervertebral fusion device, the TETRIS™ ST devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6AI-4V). Each device is available in a single footprint, with multiple heights and angulations.

The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 - S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Here's an analysis based on the provided document, addressing the acceptance criteria and study information.

This document describes a 510(k) submission for an intervertebral body fusion device (Signus Tetris™ ST / Tetris™ R ST). For such devices, clinical studies and AI/human reader performance studies are generally not required for clearance, especially when the submission focuses on manufacturing process changes for a previously cleared product. The emphasis is on non-clinical (mechanical) testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points, particularly those related to clinical studies, AI performance, and human reader studies, will be answered as "not applicable" or "no clinical testing was performed" based on the provided text.

Acceptance Criteria and Device Performance

For this specific device (intervertebral body fusion device), the "acceptance criteria" are primarily related to mechanical performance demonstrating equivalency to a predicate device, rather than diagnostic accuracy or AI performance.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set (for clinical or AI performance): Not applicable. Clinical testing was not performed to support this 510(k) submission. Mechanical testing involves samples of the device itself (e.g., a certain number of implants) to perform the specified ASTM tests, but the document does not specify the exact number of physical samples used for mechanical testing.
   • Data Provenance: Not applicable for clinical data. The mechanical testing would have been conducted by the manufacturer (SIGNUS Medizintechnik GmbH) or their designated testing facility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical test set requiring expert ground truth was used for this 510(k) submission.

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

   • Not applicable. No clinical test set requiring adjudication was used.

4. 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 device is an implantable medical device, not an AI diagnostic or assistance tool. No MRMC comparative effectiveness study was performed.

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

   • Not applicable. This device is an implantable medical device, not an algorithm.

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

   • Not applicable for clinical ground truth. For mechanical testing, the "ground truth" is adherence to established industry standards (ASTM standards) and comparison of performance metrics (e.g., stiffness, displacement) against the predicate device.

7. The sample size for the training set:

   • Not applicable. There is no AI component that requires a training set.

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

   • Not applicable. There is no AI component or training set.

Ask a specific question about this device