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The FIX-C PEEK ACIF SA System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The stand-alone interbody cages must be used with internal screw fixation. The FIX-C PEEK ACIF SA System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The FIX-C PEEK ACIF SA System consists of a stand-alone interbody fusion device with internal screw fixation. The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

The FIX-C PEEK ACIF SA System is comprised of a PEEK interbody cage and screws. The PEEK interbody cage is made from medical-grade polyetheretherketone (PEEK) which is radiolucent and contains radiopaque titanium clips made from medical-grade titanium alloys. The titanium clip assembled in the PEEK cage includes a Zero-Step Mechanism designed to prevent the screw from disengaging or loosening from the cage. The PEEK materials conform to ASTM F2026, and the titanium alloys materials conform to ASTM F1136.

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

This FDA 510(k) clearance letter is for a medical device (an intervertebral body fusion device), not a software or AI-powered device. Therefore, the information provided does not include the details about acceptance criteria, study design (sample sizes, expert adjudication, MRMC studies, ground truth establishment, etc.) that would be relevant for an AI/software-based medical device.

The clearance letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Indications for Use: The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures, which is compared to the predicate device's indications.
• Technological Characteristics: The device materials (PEEK, titanium), design features (internal screw fixation, Zero-Step Mechanism), and sterilization methods are described and implicitly compared to predicates.
• Non-Clinical Testing (Bench Tests): This is the primary "study" mentioned. The device underwent mechanical bench tests to ensure its structural integrity and performance are comparable to established standards and the predicate device.

Here's a breakdown of the information that is and is not provided in the context of your request for AI/software device evaluation:

Information Provided in the Document (Relevant to a mechanical device):

1. Acceptance Criteria & Reported Device Performance:

   • Acceptance Criteria: "All test results were higher than the acceptance criteria from the reference literature." (Specific numeric criteria not detailed, but implied to be based on ASTM standards).
   • Reported Device Performance: "All test results were higher than the acceptance criteria... Therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated." (No specific quantitative results are provided in the clearance letter itself, only the conclusion of meeting criteria.)

   Table (As much as can be constructed from the text):

   Acceptance Criteria	Reported Device Performance
   Performance higher than "reference literature" values for ASTM F2077 (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion) and ASTM F2267 (Subsidence)	All test results were reported as "higher than the acceptance criteria."
   Substantial equivalence to predicate device in mechanical performance	Substantial equivalence demonstrated.

2. Sample Sizes and Data Provenance:

   • Not applicable in the AI/software sense. This refers to physical bench testing of device units. The number of units tested is not specified.
   • Data provenance is "bench tests conducted for the subject device" (manufacturer).

3. Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth:

   • Not applicable: These concepts are entirely relevant to evaluation of diagnostic/AI software performance based on clinical image interpretation or patient data, not for the mechanical performance testing of an interbody fusion device.
   • The "ground truth" for this device's performance would be the physical measurements and results obtained from the bench tests, compared to engineering standards.

4. Training Set Sample Size and Ground Truth Establishment (Training Set):

   • Not applicable: There is no "training set" in the context of a mechanical device. These refer to the data used to train machine learning models.

Summary regarding your specific questions NOT answered by this document (because it's a mechanical device, not AI/software):

• Sample sized used for the test set and the data provenance: Not clinical data, but bench test data. Specific number of samples tested is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an algorithm).
• The type of ground truth used: Bench test measurements against engineering standards (not expert consensus, pathology, or outcomes data in the clinical sense).
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of a physical medical implant based on its compliance with established mechanical safety and performance standards (ASTM F2077, ASTM F2267) and substantial equivalence to existing devices. It does not provide the type of performance metrics, study designs, or data provenance relevant to the validation of an AI/software medical device.

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