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Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• spondylolisthesis
• trauma (i.e., fracture or dislocation)
• spinal tumor

The device is not intended for stand-alone use.

The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.

The Integra Spinous Process System is a medical device and as such, the concept of "acceptance criteria" and "device performance" as it might apply to an AI/ML model's diagnostic accuracy is not directly applicable.

Instead, the provided text describes the device's substantial equivalence to predicate devices based on technological characteristics and performance testing.

Here's an breakdown of the information that is available, structured to align with your request where possible:

(1) A table of acceptance criteria and the reported device performance

For a medical device like the Integra Spinous Process System, "acceptance criteria" are typically related to meeting established mechanical and material standards and demonstrating equivalence to legally marketed predicate devices. "Device performance" is then evaluated against these established standards and predicate devices.

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

This information is not applicable as this is a physical medical device (implant) and not an AI/ML diagnostic system. The "test set" here refers to mechanical testing of the device itself, not clinical data or patient samples. The provenance of such mechanical testing is typically the testing lab.

(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)

This information is not applicable. Ground truth, in the context of device performance, would be defined by the technical specifications outlined in the ASTM standards (F1717 and F1798) and the performance of the predicate devices. The "experts" would be the engineers and scientists who conducted and interpreted the mechanical tests.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from human expert opinions. For mechanical device testing, the results are typically objectively measured against pre-defined 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

This information is not applicable. This device is an implantable surgical system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is a physical medical device.

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

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717 and ASTM F1798, which define methods for evaluating the mechanical properties of spinal implants.
• Performance of legally marketed predicate devices: The Integra Spinous Process System's performance was compared to the performance of predicate devices (Life Spine Interspinous Fixation System, NuVasive® Spinous Process Plate System, Lanx Spinous Process Fusion Plate (SPFP), and Medtronic CD Horizon Spinous Process Plate) to demonstrate substantial equivalence.

(8) The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML model.

(9) How the ground truth for the training set was established

This information is not applicable as this is a physical medical device, not an AI/ML model.

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