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The M.U.S.T. MINI Posterior Cervical Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The M.U.S.T. MINI Posterior Cervical Screw 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, the M.U.S.T. MINI Posterior Cervical Screw System may be connected to the M.U.S.T. System rods with the M.U.S.T. MINI rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. MINI Posterior Cervical Screw System to the M.U.S.T. System. Refer to the M.U.S.T. System package insert for a list of the M.U.S.T. Indications of Use.

When used with the Occipital Plate, the M.U.S.T MINI Posterior Cervical Screw System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

The M.U.S.T. MINI Posterior Cervical Screws System straight rods (Ø3.5) are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369) and are provided in multiple lengths (30 - 115 mm in 5 mm increments). The M.U.S.T. MINI Posterior Cervical Screws System straight rods are manufactured from Ti-6A1-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy+ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)) and CoCrMo (ISO 5832-12 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy + ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)).

The provided text describes the 510(k) submission for the M.U.S.T. MINI Posterior Cervical Screws System, specifically a line extension involving straight rods. However, it does not include any information about an AI/ML-based device validation study, acceptance criteria, or performance data related to AI assistance for human readers.

The content focuses on the substantial equivalence of mechanical and material properties of the new rods compared to previously cleared devices. The "Performance Data" section explicitly states that "no additional mechanical testing were performed; no design validation was undertaken" because the new rods are equivalent to longer rods in terms of mechanical strength.

Therefore, I cannot fulfill your request for information about acceptance criteria, AI device performance, sample sizes, expert ground truth, MRMC studies, or training sets from the provided text. This document pertains to a traditional medical device (spinal implants), not an AI/ML diagnostic or assistive tool.

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