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When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:
• Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors
• Failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):
• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• Fracture
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.

This document is a 510(k) summary for medical devices (pedicle screw fixation systems), which primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving that the device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a traditional medical device submission, not an AI/ML product:

• A table of acceptance criteria and the reported device performance: This document does not present performance metrics or Acceptance Criteria for an AI/ML device. It discusses mechanical performance testing for the pedicle screw system, but that is not relevant to AI/ML acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI/ML model is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts for ground truth establishment for an AI/ML model are mentioned.
• Adjudication method for the test set: No adjudication method for an AI/ML model's test set is mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for an AI/ML model is mentioned.
• The sample size for the training set: No training set for an AI/ML model is mentioned.
• How the ground truth for the training set was established: No ground truth for an AI/ML model's training set is mentioned.

In summary, the provided text is a 510(k) submission for a pedicle screw fixation system, not a submission for an AI/ML powered medical device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not present. The document states: "No clinical data is presented." and "No mechanical data is presented: no mechanical test is required for the added components." indicating that the submission relies on engineering analysis and validation/verification to support substantial equivalence to existing predicate devices.

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