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The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of shapes and sizes of screws, 5.5mm and 6.35mm rods, and other connecting components that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. All implant components are made from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 or cobalt chrome alloy per ASTM F1537-11/ISO 5832-12.

The purpose of this submission is to add the Duetto dual headed Screws and connectors, along with associated set screws to the Adena-Zina Spinal System.

The provided text pertains to an FDA 510(k) premarket notification for the "Adena-Zina System," a thoracolumbosacral pedicle screw system. This document outlines the regulatory clearance process for a medical device and describes its intended use, materials, and a declaration of substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm or software functionality. The "Performance Testing" section only mentions bench testing for mechanical properties (static compression, static torsion, and dynamic axial compression) of the screws, as per ASTM F1717-18, which is standard for spinal implants, not for software performance or diagnostic accuracy.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them concerning AI/ML performance, because the provided input does not contain this information. The document focuses on the physical device and its mechanical properties.

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The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of a variety of shapes and sizes of screws and 5.5 and 6.35 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, fixed angle reduction screws, multi-axial and multiaxial reduction screws, T-links, domino connectors, and sacro-illiac connectors.

This document describes a 510(k) premarket notification for the Adena-Zina System, a pedicle screw spinal system. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a novel clinical study with acceptance criteria in the way a new drug or a more complex diagnostic device might.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically regarding device performance and human interpretation, is not applicable in the context of this 510(k) summary for a pedicle screw spinal system. This document primarily describes mechanical performance testing against established standards.

However, I can extract and present the information that is available concerning performance testing and the comparison to a predicate device.

Summary of Device Performance Testing (Not Acceptance Criteria in the context of a clinical study for AI/diagnostic devices):

The Adena-Zina System underwent mechanical performance testing to demonstrate its substantial equivalence to a predicate device.

Regarding the specific questions posed:

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

   • As shown in the table above, the "acceptance criteria" here are defined by meeting or exceeding the performance of the predicate device for specified mechanical tests according to ASTM standards. There are no specific quantitative acceptance criteria listed in this summary, but rather a comparative statement.

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

   • This information is not provided. The testing described is mechanical bench testing of components, not clinical data from patients. The manufacturer is Shanghai Sanyou Medical Company, Limited (China).

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):

   • Not applicable. This is mechanical testing against engineering standards, not expert-based clinical ground truth assessment.

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

   • Not applicable for mechanical bench testing.

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 medical device (implantable system) for spinal fixation, not an AI software or diagnostic imaging device that involves human readers.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for this type of submission is adherence to recognized industry standards (ASTM F1717-12, ASTM F1798-13) and comparable performance to a legally marketed predicate device (Medtronic CD Horizon Spinal System, K123809).

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence for this type of device.

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

   • Not applicable.

In conclusion: The provided document is a 510(k) summary for an orthopedic implant. The "performance testing" described refers to mechanical bench testing conducted to demonstrate that the device is substantially equivalent to a predicate device in terms of engineering characteristics. It does not involve clinical studies, human readers, or AI algorithms typically associated with the "acceptance criteria" and "study" questions posed.

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