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The 4CIS® Chiron Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Trauma (i.e., fracture or dislocation)
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
5. Tumor
6. Stenosis
7. Failed previous fusion (pseudoarthrosis).

The 4CIS® Chiron Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, instruments are available for the application and removal of the Spinal Fixation System.

This document is a 510(k) premarket notification for the "4CIS® Chiron Spinal Fixation System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data. However, it does not include detailed acceptance criteria or extensive study results that would typically be found in a clinical trial report.

Here's an analysis of the provided text in relation to your questions:

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

The document provides summary statements about performance data but does not explicitly list acceptance criteria or specific numerical results in a table format. It states:

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 mentions "Mechanical testing was performed," but does not explicitly state the sample size (e.g., number of spinal fixation systems tested) for this testing. It also doesn't specify the country of origin for the data or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically performed in a lab setting rather than involving human subjects or real-world data in the same way clinical studies do.

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 question is not applicable to the type of data presented. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under defined conditions, typically measured by engineering standards and equipment, not by expert medical interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnoses or interpretations. Mechanical testing uses objective measurements against predefined 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

No such study was mentioned or performed. This document is for a spinal fixation system, which is a physical implant, not an AI software or a device that assists human readers/diagnosticians.

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

This question is not applicable, as this is a physical medical device, not a software algorithm.

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

The ground truth for the performance of the 4CIS® Chiron Spinal Fixation System, as described, is based on mechanical testing results against established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the performance of predicate devices. This is an engineering-based ground truth.

8. The sample size for the training set

This question is not applicable. The device is a physical implant. The concept of a "training set" is relevant for machine learning models, not for mechanical testing of a spinal fixation system.

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

This question is not applicable, as there is no training set for this type of device and testing.

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The 4CIS® Chiron Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided text is a 510(k) Summary for a medical device called the "4CIS® Chiron Spinal Fixation System." It details the device's purpose, components, indications for use, and a comparison to predicate devices, including performance data. However, this document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The "Performance Data" section explicitly states:

"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) was conducted in accordance with ASTM F1717. Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device to the predicate devices."

This indicates that the performance data for this spinal fixation system is based on mechanical testing to ensure its structural integrity and equivalence to existing devices, not on the performance of an AI model in interpreting or diagnosing medical images or other data.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided document pertains to a physical medical implant and its mechanical properties.

To answer your request, I would need a document related to the regulatory submission of an AI/ML-driven medical device, which would typically involve clinical performance studies assessing the algorithm's accuracy, sensitivity, specificity, and potentially its impact on human reader performance.

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