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The Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate CCX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate Nanotec CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate PSX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate PSX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate PSX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate Nanotec PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec PSX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The subject Calibrate Interbody Systems (inclusive of Calibrate CCX Interbody System, Calibrate NanoTec CCX Interbody System, Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System) are expandable lumbar intervertebral body fusion systems designed to be inserted through a posterior or transforaminal surgical approach. The interbody spacers are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and Polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. The subject Calibrate NanoTec Interbody Systems interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the endplate surface, in addition to macro-/micro-scale topography existing from prior to treatment.

This document is an FDA 510(k) clearance letter for the Calibrate Interbody Systems. The purpose of this type of submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This process typically relies heavily on bench testing (non-clinical performance data) and comparison of technical specifications, rather than clinical studies involving human subjects or AI performance metrics.

Therefore, the requested information about acceptance criteria, study methodologies, expert ground truth establishment, MRMC studies, standalone AI performance, and training/test set details for proving device performance are not present in this document. This letter confirms the device's substantial equivalence based on non-clinical testing, primarily mechanical performance, and comparisons to predicate devices.

Here's a breakdown of why each point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions standard ASTM tests (ASTM F2077, ASTM F2267) and static push-out. It states "The results demonstrate that the subject Calibrate Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing," but does not list specific numerical acceptance criteria or performance values.

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of device approval based on substantial equivalence and non-clinical testing. The "test set" here refers to physical devices or materials undergoing mechanical stress tests, not patient data for an AI/algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI or diagnostic devices, is established by human experts (e.g., radiologists, pathologists). This document refers to the mechanical performance of an interbody fusion device, where "ground truth" would be established by engineering standards and measurements, not medical expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical studies or expert reviews of data/images to resolve discrepancies or establish a definitive "ground truth." This is not relevant for non-clinical, 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 conducted. MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices where human readers are involved. This device is an implantable interbody fusion system, not a diagnostic imaging or AI-based device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. For mechanical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM) and physical measurements.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

In summary, this FDA 510(k) clearance is based on the substantial equivalence of the Calibrate Interbody Systems to legally marketed predicate devices, supported by non-clinical performance data primarily demonstrating mechanical integrity and adherence to standardized testing protocols (e.g., ASTM F2077, ASTM F2267). The document explicitly states this in the "PERFORMANCE DATA" and "CONCLUSION" sections. The questions posed are highly relevant for AI/ML-based medical devices or diagnostic tools, but not for traditional implantable devices like the one described here.

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