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ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of nonoperative treatment.

Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

"Cervical Peek Cage" refers to a type of intervertebral cage used in spine surgery in the cervical (neck) region. ARTFX Cervical Cages cervical intervertebral devices made from PEEK Optima (per ASTM F2026) are created to be implanted into appropriate vertebral sections to help provide stability for spinal fusion after a diseased cervical disc-producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical peek cages are often used in spinal fusion surqeries.

Fusion surgeries are designed to fuse two vertebrae.

The single-use implant devices feature an open cavity in the interior geometry to accommodate autogenous bone graft and maximize bone growth, with anti-migration teeth to engage the vertebral end plates and prevent expulsion.

The ARTFX Cervical Cages are supplied sterile, single-use, and are fabricated from PEEK that conforms to ASTM F2026 for cages, and with markers and pins that are titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

ARTFX En Vivo Spinal Cervical Peek Cage has a peek cage body.

Components of the ARTFX En Vivo Spinal cage have two pins, which assist in the positive anchorage of the implant between the superior and inferior vertebral bodies, and three radiographic markers.

ARTFX Simplex Spinal XI Cervical Locking Peek Cage has a peek cage body. Components of ARTFX Simplex Spinal XI Cervical Locking Peek Cage has two titanium screws which the system is attached to the cervical spine and a titanium locking screw.

Cervical cages consist of 3 models: En Vivo Anatomical Surface, En Vivo Straight Structure, and Simplex.

This document (K240893) is a 510(k) premarket notification for a medical device called ARTFX MEDICAL Cervical PEEK Cages. It focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices.

Crucially, this document describes a physical medical implant (intervertebral cage) and its mechanical properties, not a software-based medical device that relies on algorithms for diagnostic or prognostic purposes. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of algorithms (e.g., sensitivity, specificity, human reader performance with/without AI assistance, ground truth establishment) are not applicable to this submission.

The "study" mentioned in the document refers to non-clinical mechanical testing to ensure the physical properties of the implant are comparable to the predicates, not a clinical study involving data analysis from patients or images.

Here's how the provided information relates to your questions, highlighting why most are not applicable for this type of device:

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

• Not Applicable in the traditional sense for an AI/algorithm-driven device.
• The "acceptance criteria" here relate to mechanical performance standards (e.g., load-bearing capacity, fatigue resistance) as defined by ASTM standards. The document states:
  • "Non-clinical testing including subsidence per ASTM F2267 and static and dynamic axial compression, compression-shear, and torsion per ASTM F2077 was conducted."
  • "The results showed that the performance of the proposed devices is substantially equivalent."
• A table would typically show specific force values or deformation limits from these ASTM standards, and the corresponding measured values for the ARTFX MEDICAL Cervical PEEK Cages, demonstrating they fall within the acceptable range or perform comparably to the predicate. This specific data table is not included in the provided FDA letter/summary, but the statement confirms the testing was done and met the criteria for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This refers to mechanical testing of physical implants, not data samples for an algorithm. The "sample size" would refer to the number of physical cages tested in the lab. Data provenance is irrelevant for mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the context of AI/algorithms, refers to the definitive correct answer for a diagnosis or measurement derived from expert consensus, pathology, or clinical outcome. For a physical implant, "ground truth" relates to the physical properties meeting engineering specifications, which is verified through standardized mechanical tests, not expert interpretation of data.

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

• Not Applicable. Adjudication is used for conflicting expert interpretations in clinical data for algorithms. Mechanical testing results are objective measurements from instruments.

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 specific to AI-assisted diagnostic devices. This submission concerns a physical implant.

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

• Not Applicable. This is specific to AI/algorithms. No algorithm is being submitted here.

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

• Not Applicable. As explained in point 3, ground truth for this device is established by adherence to engineering standards and mechanical test results (e.g., ASTM F2267, ASTM F2077), not by clinical expert consensus or pathology data.

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. No training set exists for this type of device.

In summary, the provided document is a 510(k) clearance letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. Therefore, the questions posed, which are tailored for AI/algorithm-based medical devices, are largely not relevant to the information contained in this specific FDA submission. The "proof" of meeting acceptance criteria for this device rests on successful non-clinical mechanical testing that demonstrated substantial equivalence to predicate devices in terms of material properties, design, and function.

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