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The Phusion Metal Cervical Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Phusion Metal Cervical Cage is intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

The Phusion Metal Cervical Cage is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The Phusion Metal Cervical Cage is anatomically shaped with two holes in the anterior end of the device each having a diameter of two millimeters extending to the inner cavity. The Phusion Metal Cervical Cage is manufactured from a porous titanium-nickel (Ti-Ni) intermetallic material. The Phusion Metal Cervical Cage is offered in a variety of shapes and sizes to accommodate variations in patient anatomy. The superior and inferior surfaces of the device has a pattern of teeth to provide increased stability and inhibit movement of the implants. Phusion Metal Cage implants are available in one lordotic configuration of 7°and heights ranging from 5 to 10 mm in 1 mm increments. The Phusion Metal Cage device is single-use only.

The provided text describes the 510(k) summary for the PorOsteon Phusion Metal Cervical Cage, a medical device for intervertebral body fusion. It outlines performance data from various tests and studies a comparison with a predicate device.

Here's the information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• No evidence of adverse tissue reaction.
• No evidence of migration or pseudoarthrosis.
• Normal bone and soft tissue at the fusion sites.
• 100% rate of fusion at 6 months (4 sheep, 2 devices/sheep).
• Statistically equivalent fusion at 6 months to the control devices based on bone histology and biomechanical motion.
• Statistically significant, higher percentage of bone contact of the superior and inferior surfaces of the devices at 4 and 6 months for the Phusion Metal devices as compared to the PEEK control devices (23.90% vs. 9.94% at 4 months and 56.09% vs. 27.31% at 6 months). |
  | Nickel Levels (in ovo model) | Normal levels of nickel (Ni) with respect to control PEEK devices and scientific literature; no evidence of abnormal nickel levels. | Histopathology of major organs, blood work, ICP-MS of blood, and serum biochemistry showed normal levels of nickel (Ni) with respect to the control PEEK devices and the scientific literature; there was no evidence of abnormal nickel levels for all tissue, blood, and serum samples. |

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

• Biomechanical Tests: "Worst-case devices" for static and dynamic compressive, shear, and torsion strength, subsidence, and expulsion testing. Specific numerical sample sizes are not provided for these in vitro tests.
• Biocompatibility Testing: Not specified, but performed per ISO 10993 standards.
• Ovine Model (in vivo study):
  • Sample Size: n = 8 sheep.
  • Test Devices: Phusion Metal Cervical Cage devices were implanted in 2 non-contiguous levels (L2-L3 and L4-L5) in each sheep.
  • Control Devices: Commercially available control devices of similar design fabricated from Zeniva PEEK material were also implanted.
  • Data Provenance: The study was performed by the Preclinical Surgical Research Laboratory, Colorado State University, USA. It was a prospective study described as being performed "per Good Laboratory Practices (GLP)".

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

The document does not mention the use of human experts to establish ground truth for the in vitro biomechanical and biocompatibility tests. For the in vivo ovine model, the ground truth was based on objective measures:

• Histology
• Micro-CT
• In-life radiography and CT
• Biomechanical evaluation
• Histopathology of major organs
• Blood work (including ICP-MS for nickel levels)
• Serum biochemistry

Therefore, the "experts" were the analytical methods and laboratory personnel performing these detailed assessments. Their specific qualifications are not detailed beyond "Preclinical Surgical Research Laboratory, Colorado State University, USA." No information regarding "number of experts" is provided in the context of human assessment for establishing ground truth for this device.

4. Adjudication method for the test set

Not applicable. The ground truth for the in vitro and in vivo studies was established through objective measurements and scientific analysis, not through human expert consensus requiring an adjudication method like 2+1 or 3+1.

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 conducted or described. This submission is for a physical intervertebral body fusion device, not an AI-assisted diagnostic tool or imaging software.

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

This question is not applicable as the device is a physical implant, not an algorithm or AI system.

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

• In vitro tests: Ground truth was based on engineering standards (ASTM) and ISO standards for material properties, biomechanical performance, and biocompatibility.
• In vivo animal study (ovine model): Ground truth was established through a combination of pathology (histology, histopathology of organs), imaging data (micro-CT, in-life radiography and CT), laboratory analysis (blood analysis, serum biochemistry, ICP-MS), and biomechanical evaluation of the fused spinal segments.

8. The sample size for the training set

This is not applicable. The device is a physical implant, and the studies described are performance and safety evaluations, not machine learning model training.

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

Not applicable, as there was no training set for a machine learning model.

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