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The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems.

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

The Catalyft™ PL Expandable Interbody System consists of implants, instruments, and cases, trays, and lids. The subject implants are expandable lordotic Titanium Alloy (Ti-6Al-4V ELI) interbody fusion implants that are provided in either an inline straight tip, known as the “PL” implant, or a hockey stick-shaped tip, which is known as the “PL40” implant. The implants are expandable and have varying footprints, heights, and lengths that provide surgeons the ability to have better control of the restoration of lordosis in patients and allows more ability to appropriately size the interbody to match patient anatomy. The subject implants are designed with a hollow center region to house autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. In addition to implants, navigated instruments compatible with the StealthStation™ system have been developed. The subject StealthStation™ System compatible instruments are specific to the subject implants, and there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission. Previously cleared Navigated Rotating Shavers (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) will be used as disc prep instruments and trials for the Catalyft™ PL system. Cases, trays, and lids have been developed for transportation of the subject instruments.

This document describes the Catalyft™ PL Expandable Interbody System and Navigated Instruments Compatible with StealthStation™ System. The document does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria and associated studies for an AI/ML device based on this document.

The document discusses the substantial equivalence of the Catalyft™ PL Expandable Interbody System and its navigated instruments to predicate devices. It mentions performance data related to mechanical testing of the implants and verification/validation testing for the navigated instruments.

Here's a breakdown of the type of information presented, which is relevant for a medical device but not an AI/ML system:

• Acceptance Criteria & Device Performance: The document lists various ASTM standards (ASTM 2077, ASTM 2267, ASTM Draft Standard F-04.25.02.02) for mechanical testing (Compression Fatigue, Compression-Shear Fatigue, Static Compression, Static Compression-Shear, Subsidence, Expulsion) of the implants. It also states that testing was completed to ensure the functionality and compatibility of new/existing instruments, and that navigated instruments underwent verification and validation activities. However, specific acceptance criteria values or detailed performance results are not provided in this summary.

• Sample Size, Data Provenance, Ground Truth for Test Set, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type (for Test Set), Training Set Sample Size, and Ground Truth for Training Set: These categories are typically associated with the evaluation of AI/ML algorithms and are not applicable to the information provided in this document, as it concerns a physical medical device and its instruments. The focus is on mechanical integrity and functional compatibility rather than algorithmic performance or diagnostic accuracy.

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