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510(k) Data Aggregation
(28 days)
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/ilum), who are having the device removed after the attainment of a solid fusion.
The Adena-Zina Spinal System consists of a variety of shapes and sizes of screws and Ø5.5mm and Ø6.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailormade 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 the originally cleared (K152781) straight and pre-bent rods, reduction screws, fixed angle reduction screws, multi-axial screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add ZINA II screws to the Adena-Zina Spinal System, along with associated class I instruments.
This FDA 510(k) Premarket Notification document describes the Adena-Zina Spinal System and the addition of ZINA II screws to this system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
There is no information in this document regarding AI/ML device performance, human reader studies, or the establishment of ground truth for such studies. Therefore, I am unable to provide the requested information related to acceptance criteria and studies that prove a device meets those criteria in the context of AI/ML.
The document pertains to the physical and mechanical aspects of a spinal implant system. The "Performance Testing" section describes bench tests performed on the ZINA II screws:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Mechanical Performance (Bench Testing) | Static Compression Bending | Equivalent to or better than the primary predicate device (K152781) | Performed equivalent to or better than the primary predicate device. |
| Mechanical Performance (Bench Testing) | Dynamic Compression Bending | Equivalent to or better than the primary predicate device (K152781) | Performed equivalent to or better than the primary predicate device. |
| Mechanical Performance (Bench Testing) | Static Torsion | Equivalent to or better than the primary predicate device (K152781) | Performed equivalent to or better than the primary predicate device. |
Note: The document states "Performance bench testing has been performed and shows that the subject ZINA II screws perform equivalent to or better than the primary predicate device." The explicit numerical acceptance criteria and reported values are not detailed in this summary, but the conclusion confirms they were met.
Regarding the other requested information (sample size, experts, adjudication, AI performance, ground truth, training set):
The provided document describes a medical device called the "Adena-Zina Spinal System" and the addition of "ZINA II screws" to it. This is a hardware device (spinal implant), not an AI/ML-driven software device. Therefore, the concepts of "test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," "training set," and "ground truth for the training set" as they relate to AI/ML devices do not apply to this submission.
The "studies" conducted for this device were mechanical bench tests per ASTM F1717, comparing the physical performance of the new components to predicate devices.
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(45 days)
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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