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The Altus Spine Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

This document describes a 510(k) premarket notification for the "Altus Spine Pedicle Screw System." It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a study proving a device meets specific acceptance criteria related to AI/software performance.

Therefore, many of the requested details, such as "acceptance criteria and reported device performance" in the context of an AI study, "sample sizes used for the test set and data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set," are not applicable to this document.

This document focuses on the mechanical and material equivalence of a physical medical device (pedicle screws) to predicate devices, supported by bench testing.

Here's a breakdown of what is in the provided text, and why the requested information isn't present:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit): For this mechanical device, the acceptance criteria are not explicitly stated in a quantitative table. Instead, the "acceptance" is demonstrating substantial equivalence to predicate devices through various tests.
   • Reported Device Performance: The document states that "Dynamic compression bend tests was performed in accordance with ASTM F1717-15. Flexion-extension, torsional grip, and axial grip was preformed in accordance with ASTM F1798-13. Bench tests demonstrated that the Altus Spine Pedicle Screw System is substantially equivalent to the predicate device."
   • Why a table isn't here: The specific numerical results of these bench tests are not provided in this summary document. The FDA 510(k) summary typically summarizes the conclusion of the tests (substantial equivalence) rather than raw data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. This is a mechanical device, and the "tests" refer to bench tests (e.g., mechanical load and fatigue testing), not clinical or AI data. There's no "test set" in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. Ground truth from experts is relevant for diagnostic AI. Here, "ground truth" for a mechanical device would be its physical properties and mechanical performance under specified loads.

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

   • N/A. Adjudication is for resolving discrepancies in expert labeling/diagnosis, which is not applicable to mechanical bench testing.

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:

   • N/A. This is a physical device, not an AI system that assists human readers.

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

   • N/A. Again, this is not an algorithm.

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

   • Implicit Ground Truth: For a physical device, mechanical properties, material composition (conforming to ASTM standards), and performance under specified load conditions (bench testing results) serve as the "ground truth" for demonstrating equivalence. This is not derived from expert consensus on medical images or pathology.

8. The sample size for the training set:

   • N/A. There is no "training set" for this type of device.

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

   • N/A. No training set exists.

In summary, the provided text pertains to a physical medical device (pedicle screws) and its regulatory clearance via a 510(k) submission, based on demonstrating substantial equivalence through bench testing. The questions asked are highly specific to the evaluation of AI/machine learning medical devices, which is not the subject of this document.

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