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The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The UBP II Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the OctaFix Occipital Cervical Plating System to allow for occipital fixation. These UBP II Bone Screws are limited to occipital fixation only.

The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.

The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spir the indications specified above.

The Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System consists of a single horse shoe shaped piece of alloyed titanium, resembling two rods that run axially along the cervical and upper thoracic spine and are joined by a flatter, plate-like section, that is intended for fixation to the occiput. Hooks, screws, and C-Fix™ cables are intended for fixation of the OctaFix Plate. UPB II Screws are intended for fixation to the occiput and Cannulated Side Loading Closed Screws are intended for fixation to the upper thoracic spine. The rods are to be fixed to the cervical spine through either cables or laminar hooks. Components of the OctaFix Occipital Cervical Plating System are manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136 and may be supplied sterile or non-sterile.

The provided document describes a medical device, the OctaFix Occipital Cervical Plating System, and its clearance through the 510(k) pathway, which establishes substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data that would establish performance against strict clinical acceptance criteria.

Therefore, the information typically requested in your query regarding acceptance criteria for device performance, ground truth establishment, expert adjudication, or MRMC studies for AI/algorithm-based devices is not directly applicable to this 510(k) submission for a spinal plating system.

Instead, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to an existing predicate device (Synthes CerviFix System) through:

• Mechanical Testing: To verify the design changes and demonstrate that the device meets functional requirements (e.g., static and fatigue data).
• Material Equivalence: Both devices are made from titanium alloy.
• Functional Equivalence: Both systems provide similar components and mechanisms for spinal fixation (bone screws for occipital fixation, hooks/cables for cervical fixation, screws for thoracic fixation), and both are based on a rod-plate component.

Here's how to address your points given the available information:

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

   Acceptance Criterion	Reported Device Performance
   Design Verification	Mechanical testing data collected in accordance with ASTM 1717 provided.

Static and fatigue data demonstrated that the design met all functional requirements. |
| Material Equivalence | Manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136, similar to the predicate device. |
| Form, Fit, and Function | Determined to be substantially equivalent to the predicate device (Synthes CerviFix System) in terms of fit, form, and function. |

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

   • Sample Size: Not specified for the mechanical testing. ASTM 1717 outlines standard testing procedures for metallic spinal implant constructs, which would involve a specific number of test articles. The document does not provide details on the number of devices tested.
   • Data Provenance: The mechanical testing was conducted to verify design changes. This type of data is typically generated in a laboratory setting by the manufacturer (Spinal Concepts, Inc.) in the United States, as required for device clearance. It is inherently "prospective" in the sense of being generated specifically for the submission, but it's not clinical 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 information pertains to studies establishing diagnostic or prognostic accuracy, typically with human interpretation as ground truth. For a mechanical device, performance is established through engineering and biomechanical testing, not expert interpretation of results in the traditional sense of a clinical study. The "experts" involved would be biomechanical engineers and material scientists.

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

   • Not applicable. Adjudication methods are relevant for clinical studies where human experts assess cases (e.g., medical images). For mechanical testing, the "ground truth" is determined by the physical properties measured against engineering standards.

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. This device is a passive implantable medical device (spinal plating system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

   • Not applicable. This device is a physical implant, not an algorithm or software.

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

   • Not applicable in the clinical sense. For the mechanical testing, the "ground truth" is established by the specified engineering standards (ASTM 1717) and the physical properties of the materials and design, which are quantitatively measured and compared against defined functional requirements and the predicate device's performance.

8. The sample size for the training set

   • Not applicable. This concept relates to machine learning models. This device does not use a "training set."

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

   • Not applicable. See point 8.

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