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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 subject M.U.S.T. MINI Posterior Cervical Screws System Extension is a Medacta M.U.S.T. MINI Posterior Cervical Screws System line extension. Specifically, the current submission includes the following implants:

• M.U.S.T. MINI Polyaxial screw dual lead solid and cannulated with diameters ranging from 4 to . 6mm and lengths from 20 to 50mm;
• M.U.S.T. MINI cross connector top load, four sizes. ●

The subject devices are made of Ti6A14V ELI according to ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy and ASTM F136-13 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is a 510(k) Summary for the Medacta M.U.S.T. MINI Posterior Cervical Screws System Extension. This document describes a medical device (surgical implants) and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML powered medical device, therefore, the requested information cannot be extracted.

The request asks for specific details related to an AI/ML powered medical device, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and results of comparative effectiveness studies (MRMC) or standalone performance studies. These are all concepts relevant to the evaluation of AI/ML software.

Since the provided text concerns mechanical surgical implants, these categories do not apply. The "Performance Data" section in the document refers to non-clinical studies (design validation, geometric comparison, dynamic biomechanical testing, pyrogenicity, biocompatibility, shelf-life) and explicitly states "No clinical studies were conducted." The non-clinical studies support the substantial equivalence of the new implants to previously cleared mechanical implants, not the performance of an AI/ML algorithm.

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