Search Results

The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.

The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and maior axis length of 810-1390μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

This document describes a 510(k) premarket notification for the ZSFab Cervical Interbody System. The filing is for the addition of new sizes to an existing device (K202488). The document does not describe a study involving an AI/CADe device or a study with specific acceptance criteria that would include metrics like sensitivity, specificity, or AUC, as it is a filing related to a physical medical device (interbody fusion system) and not an AI-based diagnostic or imaging tool.

Therefore, most of the requested information regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set would not be applicable to this type of device submission.

The "Performance Data" section in the document refers to mechanical testing for the physical device, not an AI/CADe system.

Here's a breakdown of why each item is not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "Performance Data" section mentions mechanical testing (static/dynamic axial compression, torsion, subsidence, expulsion) according to ASTM standards and sterilization validations (AAMI ST79). These are material and physical performance criteria, not clinical performance metrics for an AI/CADe system. The document states an "engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." This is a justification for not repeating full mechanical testing for new sizes, not an acceptance criterion table for an AI.

2. Sample size used for the test set and the data provenance: Not applicable. There is no test set of patient data for an AI/CADe system. The "worst case" in mechanical testing refers to the most challenging physical configuration of the device, not a patient sample.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/CADe system in this submission.

4. Adjudication method for the test set: Not applicable. No test set for AI/CADe.

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 not an AI-assisted device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no ground truth for an AI/CADe system in this submission. The "ground truth" for a physical device like this would relate to its structural integrity and biocompatibility, typically established through material testing and established medical standards.

8. The sample size for the training set: Not applicable. There is no algorithm or training set for an AI/CADe system.

9. How the ground truth for the training set was established: Not applicable. No training set.

Ask a specific question about this device

The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.

The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar implantation. The implants are designed as a solid frame that includes lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with axis lengths of 610-1000µm. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620-710µm. Each lumbar interbody has a central cavity for bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are sold sterile.

The provided document is a 510(k) summary for a medical device (ZSFab Lumbar Interbody System), which focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and mechanical performance. It does not contain information about the performance of an AI/ML powered device, nor does it discuss clinical studies with human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies as would be relevant for an AI/ML product.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets those criteria in the context of an AI/ML device. The document primarily describes pre-clinical (mechanical) testing of a spinal implant.

Ask a specific question about this device