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The Mega Plus MIS Spine System is 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.

The Mega Plus MIS Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link. Various sizes of these implants are available. Mega Plus MIS Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Mega Plus MIS Spine System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously for the Mega Plus Spine System (K173180, K183080).

The provided text describes a 510(k) premarket notification for the "Mega Plus MIS Spine System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data or acceptance criteria for AI/ML performance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as you've outlined, is not present in this document.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use/Indications for Use: For what medical conditions and patient populations the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Performance Data: This section mentions non-clinical testing (mechanical tests) per ASTM F1717, but it does not provide acceptance criteria or specific results in the form of a table. It simply states that "The results of this non-clinical testing show that the strength of the Mega Plus MIS Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

In summary, this document does not contain the information needed to answer your questions because it pertains to a traditional medical device (spinal fixation system) and its mechanical performance testing for substantial equivalence, not an AI/ML-driven device requiring clinical performance criteria, expert adjudication, or separate training/test sets as described in your request.

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