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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 clinical image (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 a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.

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, MRL). 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 marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.

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 major axis length of 810-1390μm. The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar 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 610-1000m. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620-710m. Each cervical and lumbar interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

This document is a 510(k) premarket notification from the FDA, approving the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against novel acceptance criteria through a clinical validation study of an AI/software device.

Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies is not present in this document. This submission does not describe a study that validates a device's performance against defined clinical metrics or uses an AI algorithm.

The "Performance Testing" section refers to mechanical testing (e.g., static and dynamic axial compression, torsion, subsidence, expulsion) to show the physical properties of the manufactured devices are equivalent to the predicate devices. This is a common requirement for implantable medical devices to demonstrate that manufacturing changes (like a new location) do not alter the established mechanical performance of the product.

In summary, this document does not contain the information required to answer your questions about acceptance criteria, study design, and performance data for an AI/software-based medical device.

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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.

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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 to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

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 720-760μm and major axis length of 1030-1060μm. 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.

The provided document is a 510(k) summary for the ZSFab Cervical Interbody System, a medical device intended for anterior interbody fusion in the cervical spine. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The information primarily focuses on the physical and mechanical performance of the device in comparison to a predicate device, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, ground truth methodology for AI, MRMC studies, and standalone algorithm performance, are not applicable to this device and the type of performance data presented.

Below is the information that can be extracted from the provided text, primarily focusing on the mechanical testing performance of the device, which is the "study" demonstrating it meets acceptance criteria for substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Note: The document states that "The mechanical test results demonstrate that the ZSFab Cervical Interbody System performance is substantially equivalent to the predicate devices." This implies that the performance of the ZSFab device met or exceeded the performance of the predicate device under these specified test conditions, thus fulfilling the acceptance criteria for substantial equivalence. Specific quantitative values for the acceptance criteria and the device's exact performance against those criteria are not detailed in this summary.

Study Details (Focusing on the Mechanical Testing)

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

   • Sample Size: Not specified in the summary. For mechanical testing, samples typically refer to individual devices tested.
   • Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). These are laboratory bench tests.

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

   • Not applicable. Mechanical testing relies on standardized test methods (ASTM standards) and engineering principles, not expert interpretation of outputs.

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

   • Not applicable. Mechanical testing results are objective measurements directly compared against predefined specifications within the ASTM standards.

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 is a spinal implant, not an AI diagnostic or assistance device.

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

   • Not applicable. This is a spinal implant, not an AI device.

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

   • For mechanical testing, the "ground truth" is defined by the objective pass/fail criteria established within the referenced ASTM international standards (F2077 and F2267) for intervertebral body fusion devices, and potentially internal specifications derived from the predicate device's performance.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being trained for this device. The "training set" would not be relevant in a mechanical testing context. If interpreted very broadly, it might refer to samples used during design and development iterations, but this is not reported here.

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

   • Not applicable, as there is no AI training set.

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