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When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
• Spondylolisthesis
• Spinal Stenosis
• Fracture/dislocation
• Failed previous fusion
• Atlanto/axial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumors

The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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

The AIS® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occiptio-cervico-thoracic junction (occiput-T3). The AIS® S4 Cervical Occipital Plate Spinal System consists of plates, bone screws, rods, hooks, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS® S4 Cervical Occipital Plate Spinal System is manufactured from Titanium Alloy and will be provided non-sterile.

The provided text is a 510(k) summary for the Aesculap S4 Cervical Occipital Plate Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It is not a study that proves a device meets acceptance criteria in the context of AI/ML performance, diagnostic accuracy, or human factor studies.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's an attempt to answer the questions based on the available text:

Acceptance Criteria and Device Performance Study for the Aesculap S4 Cervical Occipital Plate Spinal System

This submission is a 510(k) for a spinal implant system. The "acceptance criteria" here refers to the device's ability to meet industry standards for mechanical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance metrics.

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

Note: The document states the device was performed in accordance with the listed ASTM standards and that results demonstrate safety and effectiveness. It does not provide specific numerical acceptance criteria or performance values beyond this qualitative statement.

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

The document does not specify the sample size (number of implants tested) for the mechanical performance tests. The data provenance is also not specified, as these are in-vitro mechanical tests, not clinical data from patients.

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 is not applicable. "Ground truth" in the context of expert consensus is relevant for studies involving diagnostic accuracy or image interpretation. For mechanical testing of a spinal implant, the "ground truth" is defined by the physical properties and engineering specifications measured in a laboratory setting against established ASTM standards. No human experts are used to establish ground truth in this type of study.

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

Not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by human readers). Mechanical testing is objective.

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 spinal implant, not an AI/ML powered diagnostic device, nor a device that involves human readers for interpretation.

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

Not applicable. This is a physical medical device (spinal implant), not an algorithm or software.

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

The "ground truth" for the mechanical performance testing would be the quantitative measurements obtained from the various tests (static compression, torsion, bending, fatigue, pull-out) and their comparison against the specifications outlined in the referenced ASTM standards (F1717, F2067, F543).

8. The sample size for the training set

Not applicable. Mechanical testing for substantial equivalence does not involve "training sets" as understood in AI/ML.

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

Not applicable.

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