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ANAX™ OCT Spinal System is 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 (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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. ANAX™ OCT Spinal System is 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, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal Sytem and ANAX™ 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

The ANAX™ OCT Spinal System is manufactured by U&I corporation. The ANAX™ OCT Spinal System is for fixation the cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse (cross) links and occipital plate. Connectors are also provided for surgical convenience. The ANAX™ OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The single-use ANAXTM OCT Spinal System components are supplied as nonsterile and are fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAXTM OCT Spinal System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAXTM OCT Spinal System implants.

The provided text describes the ANAX™ OCT Spinal System, a spinal fusion device, and its 510(k) submission for substantial equivalence. The document does not contain information about a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it focuses on the substantial equivalence of the ANAX™ OCT Spinal System to a predicate device, based on mechanical performance and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/Machine Learning device, as this information is not present in the provided text.

The text explicitly states:
"Any mechanical test in non clinical setting (bench testing) was not conducted on the ANAX™ OCT Spinal System. However, the mechanical strength evaluation was conducted to compare data of proposed device of the ANAX™ OCT Spinal System(K150570) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The data met all acceptance criteria and that verifies performance of the ANAXIM OCT Spinal System is substantially equivalent to predicate devices."

This indicates that the "study" proving the device meets acceptance criteria was a comparison to existing data from the predicate device (ANAX™ OCT Spinal System K150570) regarding mechanical strength, rather than a de novo study with a new dataset for performance evaluation. The acceptance criteria themselves are simply that its mechanical performance "met the acceptance criteria which have been established from the predicate devices" and that its performance "is substantially equivalent to predicate devices." No specific numerical or qualitative acceptance criteria are provided in the text.

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