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The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with 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 one or multiple contiguous levels from C2-T1.

The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The FIX-C 3D Ti ACIF System comprises of 3D-printed porous titanium spinal cages intended to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion (ACIF) procedures. The devices are intended to be used with supplemental spinal fixation (e.g., using anterior plate system).

The spinal cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures. The hollow geometry of the spinal cages allows them to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft.

The FIX-C 3D Ti ACF System is manufactured in a pre-designated standard size, not patient-matched. The spinal cages are available in various sizes, footprints, heights, and angles.

The FIX-C 3D Ti ACIF System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.

This document is an FDA 510(k) clearance letter for a medical device called the "FIX-C 3D Ti ACIF System," an intervertebral body fusion device. The request asks for details about the acceptance criteria and the study that proves the device meets them. However, the provided text primarily describes the regulatory clearance process and device characteristics, and does not contain detailed information about specific performance acceptance criteria or a clinical study that proves the device meets those criteria.

Instead, it refers to bench testing as the primary method for demonstrating equivalence.

Here's what can be extracted and what information is missing:

Information Present in the Document:

• Device Name: FIX-C 3D Ti ACIF System
• Device Type: 3D-printed porous titanium spinal cages for anterior cervical interbody fusion (ACIF).
• Regulation Number: 21 CFR 888.3080 (Intervertebral Body Fusion Device)
• Regulatory Class: Class II
• Product Code: ODP
• Intended Use/Indications for Use: For anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging, resulting in radiculopathy, myelopathy, and/or pain at C2-T1 levels. To be used with supplemental fixation systems cleared for cervical spine, autogenous and/or allogeneic bone graft. Patients should have had at least six weeks of nonoperative treatment.
• Predicate Devices: K233839 (Peridot-PT Anterior Cervical Intervertebral body fusion System), K241738 (PYXIS 3D Titanium Cervical Cage System), K212266 (FIX-C PEEK Anterior Cervical Interbody System).
• Main Study Type: Bench tests, not clinical data.
• Standards Followed for Bench Tests:
  • ASTM F2077, Standard Test Methods for Intervertebral Body Fusion Devices (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion tests)
  • ASTM F2267, Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (Subsidence test)
• Conclusion of Bench Tests: "All test results were higher than the acceptance criteria from the [text cut off] therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated."

Missing Information (and why it's missing from this FDA letter):

The FDA 510(k) summary letter is an official decision document, not the detailed study report. It summarizes the basis for clearance, including the types of tests performed and the ultimate conclusion of substantial equivalence. It generally does not include the granular details of study protocols, raw data, or specific acceptance criteria values in the public summary.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not specified. The text only states "All test results were higher than the acceptance criteria". It doesn't list the numerical values of these criteria.
• Reported Device Performance: Not specified. The exact numerical results of the ASTM F2077 and ASTM F2267 tests are not provided. It only concludes that they met and exceeded the (unspecified) criteria.

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

• Sample Size for Test Set: Not specified. While bench tests were conducted, the number of devices or iterations tested is not mentioned.
• Data Provenance: The tests were "Bench tests" which means they are laboratory-based, not patient-derived. Therefore, there's no country of origin or retrospective/prospective distinction for the "data" in the clinical sense.

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

• Not Applicable. This device clearance is based on bench testing for mechanical performance and substantial equivalence to legally marketed predicate devices, not on a clinical ground truth established by experts.

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

• Not Applicable. This is relevant for clinical studies, especially those involving human interpretation of data, not for mechanical bench 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:

• No MRMC study was done. The document explicitly states "Clinical data is not applicable." This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not Applicable. This device is an implant, not an algorithm.

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

• For the bench testing, the "ground truth" is established by the specified ASTM standards and the mechanical properties they measure (e.g., load-bearing capacity, subsidence). It's a mechanical performance "ground truth" based on established engineering standards, not clinical ground truth.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device through engineering bench tests, rather than a clinical study with human readers or AI algorithms. Therefore, most of the requested information regarding clinical study methodologies, expert ground truth, and AI-specific details is not contained within this document. To obtain such granular detail on acceptance criteria and performance data, one would typically need to review the full 510(k) submission, which is generally proprietary.

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