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The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors.

The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

The Spinal Elements Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks, and transverse connectors. Screws are intended for attachment to the thoracic (T1-T3) spine only. All components of the system are manufactured from titanium alloy (Ti-6A1-4V conforming to ASTM F 136 or ISO 5832-3). The system achieves fixation by the mechanical joining of the rods, screws, hooks, and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Spinal Elements Posterior Cervical/Thoracic Spinal System:

The provided text describes a medical device, its intended use, and the performance testing conducted. However, it does not contain information about a study proving the device meets acceptance criteria in the context of human performance (e.g., accuracy of a diagnostic AI product) or clinical outcomes. Instead, the document focuses on mechanical performance testing for a spinal implant system to demonstrate its substantial equivalence to predicate devices.

Therefore, many of the requested categories (e.g., AI performance, expert ground truth, sample sizes for training/test sets, MRMC studies) are not applicable to the information provided.

Let's break down what is available in the input:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document states "All test results indicate the system will perform as intended." This is a general statement. Specific numerical thresholds for "acceptance" (e.g., "withstanding X N of force") and the actual measured results are not provided in this summary. The "acceptance criteria" here are implied by the nature of the mechanical tests (i.e., the device should not fail under the tested conditions as defined by ASTM F1717).

The following sections are largely not applicable or cannot be fully answered based on the provided text, as the study described is a mechanical bench test, not a clinical or AI performance study.

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

• Sample Size: Not specified for the mechanical tests. ASTM F1717 would define the number of samples required for each test type (static, dynamic, torsion).
• Data Provenance: The tests are "non-clinical, mechanical testing," implying benchtop lab testing rather than human or animal data. The location of the testing is not specified, but it's presumed to be in a controlled laboratory environment. It is not retrospective or prospective in the clinical sense.

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

• Not Applicable. Mechanical testing does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The "ground truth" is defined by the physical properties and performance requirements of the materials and design, tested against established standards (ASTM F1717).

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

• Not Applicable. Adjudication methods are relevant for subjective assessments, typically in clinical or image-based studies where different human readers might interpret data differently. Mechanical tests have objective outcomes (e.g., fracture, deformation, yield strength).

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 a mechanical device, not an AI diagnostic tool.

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

• Not Applicable. This is a mechanical device, not an AI algorithm.

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

• The "ground truth" for this device's performance is its ability to meet the mechanical performance standards defined by ASTM F1717 for spinal implant constructs. This is a physical/engineering standard, not a biological or clinical one (like pathology or outcomes data).

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; there is no training set.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

Conclusion:

The K120467 document details the mechanical safety and performance of a spinal implant system through conformity to established ASTM standards. It does not involve AI, human reader studies, or complex ground truth establishment by medical experts for diagnostic accuracy. The "study" referenced is a series of in-vitro mechanical tests, and its "acceptance criteria" are implied by the successful performance of the device under these standardized conditions, demonstrating substantial equivalence to predicate devices.

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