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When used for anterior screw fixation or as a posterior, non-pedicle system of the U.L.I.S.™ and LUMISTM 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
• · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• 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 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
• · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• · 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 design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods.

The provided text describes a medical device submission (K133575) for the SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System and U.L.I.S.™ Pedicle Screw Fixation System. The submission focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not through clinical or AI-powered studies. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, and AI-specific metrics) are not applicable or cannot be extracted directly from this document.

Here's the information that can be extracted and a clear indication where certain information is not provided:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SpineVision LUMIS™ and U.L.I.S.™ systems are primarily based on demonstrating comparable mechanical properties to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: This information is not provided. The study involved mechanical testing of device components, not a test set of patient data.
• Data Provenance: Not applicable in the context of mechanical testing. The testing was conducted in a laboratory setting as part of the device's engineering analysis and design validation/verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "ground truth" derived from expert consensus on patient data. The "truth" in this context is established by engineering standards and measurements from mechanical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human-reviewed data, not mechanical testing results where outcomes are quantifiable and objectively measured against engineering standards.

5. 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

Not applicable. This device is a pedicle screw fixation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted, and the concept of "human readers improve with AI" is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating the device's safety and effectiveness relies on engineering standards and direct measurements from mechanical testing. The comparability to predicate devices, as assessed through these tests, serves as the basis for the substantial equivalence determination. There is no clinical ground truth (like pathology or outcomes data) mentioned in this summary for the purpose of demonstrating equivalence.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device and its mechanical properties, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model.

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