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The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.

The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.

The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.

This document describes a 510(k) premarket notification for the "Zero-P Natural Plate System," a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance level of an AI device through a clinical study. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this type of regulatory submission.

However, I can extract information related to the device's performance data as presented in the document, which focuses on mechanical and biomechanical testing demonstrating equivalence to predicate devices, rather than AI performance.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance:

The document describes performance data through mechanical and biomechanical testing, compared to predicate devices, to establish substantial equivalence. It does not provide specific numerical "acceptance criteria" and "reported device performance" in the format of AI metrics (e.g., sensitivity, specificity). Instead, it states that the mechanical and biomechanical properties were evaluated and found to be "consistent with those of the predicate devices," thereby establishing substantial equivalence.

Study Details (as applicable to a medical device, not an AI model):

1. Sample size used for the test set and the data provenance:

   • Mechanical Testing: Not explicitly stated as a "sample size" in the context of an N-number for a test set. ASTM F1717-14 specifies methodologies for testing implants.
   • Biomechanical Testing: "cyclic cadaveric range of motion study." The number of cadaveric specimens used is not specified.
   • Data Provenance: Not specified, but likely laboratory testing data rather than patient data.

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

   • Not Applicable. This is a physical and biomechanical testing study for a medical implant, not an AI study requiring expert consensus for ground truth on clinical data.

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

   • Not Applicable. No human adjudication process is described for this type of testing.

4. 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 or an MRMC study.

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

   • Not Applicable. This is not an AI algorithm.

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

   • For mechanical testing, the "ground truth" would be the physical properties and failure modes under defined loads as measured by testing equipment, adhering to ASTM standards.
   • For biomechanical testing, the "ground truth" would be the measured range of motion and stability characteristics in cadaveric models. This is not "expert consensus" or "pathology" in the AI/clinical sense.

7. The sample size for the training set:

   • Not Applicable. This is not an AI model.

8. How the ground truth for the training set was established:

   • Not Applicable. This is not an AI model.

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