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The INFINITY™ OCT System is intended to provide immobilization and stabilization 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.
• Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

To achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system. The system consists of a variety of shapes and sizes of plates, rods, hooks, set screws, multiaxial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Per this 510(k) submission, Medtronic is seeking the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that will be part of the INFINITY TM OCT System. These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility.

The provided text from the FDA 510(k) K223764 does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML algorithm's performance.

Instead, the document pertains to a Class II medical device, the Medtronic INFINITY™ OCT System, which is a posterior occipitocervical-upper thoracic system used for spinal immobilization and stabilization. The 510(k) submission is for the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that are part of this system. The key aspect of this submission is that these new components are identical in design and material to previously cleared components (K163375) and the only change is sterility.

Therefore, the document explicitly states:

• "These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility." (Page 4)
• "The subject devices do not represent a new worst-case and the testing for the predicate devices is deemed applicable for the subject devices. The sterilization justification for the predicate devices adopts the subject devices into existing steam validation documents. The subject devices and the predicate devices have identical designs, materials, and manufacturing processes. Therefore, no additional bench performance testing is needed." (Page 6)

Given this, the document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of AI/ML (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance). The "study" described (or rather, the justification for no new study) is simply the assertion of substantial equivalence based on identical design, material, and manufacturing process with the predicate device, with only a change in sterilization.

Thus, I cannot populate the requested table or answer the specific questions about AI/ML study methodologies based on the provided text. The document clearly indicates that no new performance data was required because the new components are essentially the same as previously cleared ones, differing only in sterilization.

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