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The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems 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 occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

The provided document is a 510(k) summary for the Aesculap S4 Cervical Spinal and Occiput Systems. It describes the device, its indications for use, and a comparison to predicate devices. It also details the performance testing conducted. However, this document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device, as the Aesculap S4 Cervical Spinal and Occiput Systems are physical medical implants, not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this submission pertains to a physical orthopedic implant system, not a digital health or AI/ML device.

The "Performance Data" section solely refers to non-clinical mechanical testing of the implant system against established ASTM standards to demonstrate substantial equivalence to predicate devices, not clinical performance data or AI/ML specific metrics.

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The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervicothoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
• . Spondylolisthesis,
• Trauma (i.e., fracture or dislocation), .
• . Spinal Stenosis,
• Atlanto-axial fracture with instability, .
• Failed previous fusion, .
• Occipito-cervical dislocation, .
• Revision of previous cervical spine surgery, ●
• Spinal tumors. ●

The occipital bone screws are limited to occipital fixation only.

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

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.

The Certex OCT Spinal Implant System consists of screws, hooks, rods, plates and connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex OCT Spinal Implant System components are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided clean but non-sterile.

Here's an analysis of the provided text regarding the Certex™ OCT Spinal Implant System's acceptance criteria and the study proving its performance:

Important Note: The provided document is a 510(k) summary for a spinal implant system. These types of devices are typically evaluated based on their mechanical and biocompatibility performance and their substantial equivalence to a predicate device, not on accuracy metrics like those used for AI/diagnostics. Therefore, many of the requested fields (e.g., sample size for test set, number of experts, MRMC studies, ground truth for training) are not applicable to this type of device and study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" as this is a mechanical engineering study, not a clinical study with patient data. The "samples" would refer to the number of physical implant constructs tested, which is not detailed in the summary.
• Data Provenance: Not applicable in the context of patient data. The tests were conducted on physical device components and constructs, likely in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective, as these terms are for clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to recognized testing standards and measurement protocols, not by expert consensus on clinical data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing results are objective measurements against defined standard criteria, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This device is a passive spinal implant, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? No.
• Details: Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this type of device is defined by the acceptance limits and methodology outlined in the cited ASTM (American Society for Testing and Materials) standards (ASTM F2706 and ASTM F1798). These standards dictate how the tests are performed and what constitutes acceptable mechanical performance (e.g., strength, stiffness, fatigue resistance, slip).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical implant, and the performance data presented is derived from mechanical testing against established standards, not from a machine learning model with a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned, there is no "training set" in this context.

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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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