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The Octane® Straight Intervertebral Fusion Device, Ti Coated is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Exactech® Octane® Straight Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1). The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers to permit verification of position. The device is plasma coated with commercially pure titanium. The Octane Straight Spinal Implant is provided sterile for single use.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

This document is a 510(k) premarket notification for the Octane® Straight Intervertebral Fusion Device, Ti Coated. The purpose of this submission is not for a medical imaging AI device, but for an intervertebral fusion device (a spinal implant). Therefore, many of the requested categories related to acceptance criteria, AI performance, ground truth, and expert evaluation are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the performance data and the conclusion of substantial equivalence.

Here's the breakdown of the information that can be extracted:

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

   This document does not specify quantitative acceptance criteria in a table format with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed and states a general conclusion.

   Acceptance Criteria Category	Reported Device Performance
   Mechanical Strength	"sufficient for its intended use"
   Substantial Equivalence	"substantially equivalent to legally marketed predicate devices"

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. The tests performed are non-clinical (mechanical/material tests on the device itself), not studies on patient data.

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. This is not an AI/diagnostic device that requires expert ground truth.

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

   Not applicable.

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 not an AI device.

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

   Not applicable. This is not an AI device.

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

   Not applicable directly as "ground truth" for a diagnostic finding. The "ground truth" for this device's performance would be the specifications and requirements defined by the ASTM standards and the predicate device's performance, against which the subject device's mechanical and material properties are compared.

8. The sample size for the training set

   Not applicable. This is not an AI device.

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

   Not applicable. This is not an AI device.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria essentially refers to the performance data from the non-clinical testing. The document states:

• Tests Performed:

  • Static axial compression per ASTM F2077
  • Static compressive shear per ASTM F2077
  • Dynamic axial compression per ASTM F2077
  • Dynamic compressive shear per ASTM F2077
  • Percent Porosity per ASTM F1854-09
  • Coating Thickness per ASTM F1854-09
  • Static Shear per ASTM F1044-05
  • Static Tensile per ASTM F1147-05
  • Shear Fatigue per ASTM F1160-05
  • Abrasion per ASTM F1978-00

• Conclusion: "The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The predicate devices used for comparison are:

• Primary Predicate: Octane® Straight Intervertebral Fusion Device, Manufacturer: Exactech, Inc. (K130434) - Note: This suggests the current device is an iteration (addition of Ti coating) of a previously cleared device from the same manufacturer.
• Reference Predicate: Calix™ PC Spinal Implant System, Manufacturer: X-Spine (K112036)

In summary, for this particular medical device (a spinal implant), the "study" consists of a series of non-clinical, bench-top mechanical and material property tests conducted according to recognized ASTM standards. The "acceptance criteria" are implied by these standards and the equivalence to the predicate devices, ensuring the device has "sufficient" strength for its intended use. There are no elements related to AI performance, human reader studies, or diagnostic accuracy in this submission.

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