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The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

The Altus Spine Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026 (Invibio PEEK-Optima® LT1 or Solvay Specialty Polymers Zeniva™ ZA-500 PEEK), and titanium alloy conforming to ASTM F136 or tantalum conforming to ASTM F560. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.

The Altus Spine Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

This document is a 510(k) premarket notification for the "Altus Spine Interbody Fusion System." It describes a medical device, its intended use, and claims substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device.

The document describes a physical medical device (an intervertebral body fusion device) made of PEEK and titanium/tantalum. The performance evaluation mentioned is mechanical testing in accordance with ASTM F2077 and ASTM F2267 for static and dynamic compression, shear compression, subsidence, and expulsion. This is a standard evaluation for implantable orthopedic devices, not an AI/ML clinical performance study.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it relates to AI/ML.

Here's why the provided text isn't relevant to your request:

• Device Type: This is a physical intervertebral fusion device, not an AI/ML-powered diagnostic or therapeutic tool.
• Performance Evaluation: The "non-clinical tests" mentioned are mechanical tests for the structural integrity and stability of the implant, not clinical performance metrics typical for AI/ML algorithms (like sensitivity, specificity, AUC, recall, etc.).
• No AI/ML Components: The document does not mention any artificial intelligence, machine learning, software, or algorithms as part of the "Altus Spine Interbody Fusion System."

If you have a different document related to an AI/ML device, please provide it.

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