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The Innovasis PFX™ Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

• · Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• · Trauma: fracture or dislocation
• · Spondvlolisthesis
• Tumor

The Innovasis® PFX™ Posterior Spinous Fixation System consists of plates, struts and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. PFX™ implants are composed of titanium alloy (per ASTM F136).

The provided document describes the Innovasis PFX™ Posterior Spinous Fixation System, a medical device, and its testing for substantial equivalence to predicate devices. The study conducted is a non-clinical performance study focused on mechanical testing rather than a clinical study involving human subjects or AI performance.

Therefore, many of the requested criteria related to clinical studies, AI performance, and human expert review are not applicable to the information provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• "The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine."
• "The materials utilized (titanium alloy) are substantially equivalent to the predicates."
• "The mode of operation (clamping mechanism utilizing wings and spikes, center post and set screw) is substantially equivalent to the predicates."
• "The indications for use are substantially equivalent." |

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 for Test Set: Not explicitly stated as a number of physical devices. The "tests" section implies multiple tests were conducted (e.g., Axial Pushoff, Static Compression Bending, etc.), each likely on a sample of devices. However, the exact sample size for each specific test (e.g., how many devices for axial pushoff) is not detailed.
• Data Provenance: The tests are non-clinical (mechanical testing). There is no "data provenance" in terms of patient data or country of origin for such data. The tests were performed to ASTM standards, which are internationally recognized.

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 was a non-clinical mechanical performance study, not a study evaluating diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

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

• Not Applicable. As a mechanical performance study, there was no need for adjudication by human experts. The "ground truth" was derived from the physical testing measurements 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

• Not Applicable. This document describes a medical device's physical performance, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not Applicable. This is not an AI algorithm. It is a physical spinal fixation device.

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

• The "ground truth" for this non-clinical study was the performance parameters defined by recognized industry standards (ASTM F1798 and ASTM F1717) and comparative performance to predicate devices. The device was deemed to have met the acceptance criteria if its mechanical performance was comparable to, and ideally exceeded, that of the predicate devices under standardized test conditions.

8. The sample size for the training set

• Not Applicable. This is a physical device, not a machine learning model; therefore, there is no "training set."

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

• Not Applicable. There is no training set for this type of device submission.

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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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