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The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.

The Baxano Surgical MIS Pedicle Screw System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome. When assembled, the components are implanted via a percutaneous, mini-open or open delivery to create a rigid structure to provide stabilization and promote spinal fusion. The system consists of an assortment of polyaxial cannulated pedicle screws, rods, cross connectors and locking caps, and associated instruments.

This document describes the premarket notification (510(k)) for the Baxano Surgical MIS Pedicle Screw System, a medical device. The information provided focuses on the mechanical testing of the device to demonstrate its substantial equivalence to a predicate device, rather than a clinical study involving human readers or algorithm performance for image analysis.

Therefore, many of the requested categories related to clinical studies, human reader performance, ground truth establishment for images, and training sets for algorithms are not applicable to this submission.

Here is an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The acceptance criteria for the Baxano Surgical MIS Pedicle Screw System were established by applicable ASTM standards for spinal implant testing. The reported device performance demonstrated that it met or exceeded these requirements.

Study Information (Mechanical Testing)

This submission relies on non-clinical mechanical testing rather than a clinical study.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document states that testing was performed on the "worst case subject device" and "components of the Baxano Surgical MIS Pedicle Screw System." It does not specify an exact numerical sample size for the mechanical tests, but implied that multiple components or configurations were tested to represent the worst-case scenario.
   • Data Provenance: The testing was conducted internally or by a contracted lab, as it refers to "test protocol." It is non-clinical, controlled laboratory testing.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. The "ground truth" for mechanical testing is defined by the performance standards (ASTM) and the physical properties of the materials and design, not by expert interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert disagreement in image interpretation or clinical diagnosis. Mechanical testing results are objective measurements against defined standards.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This is a mechanical device submission, not an AI or image analysis device subject to MRMC studies.

5. Standalone (Algorithm Only) Performance Study:

   • No. This is not an algorithm-based device.

6. Type of Ground Truth Used:

   • The "ground truth" for this device's performance is the mechanical performance standards set by ASTM (e.g., F1717-13, F543-07, F1798-97).

7. Sample Size for the Training Set:

   • Not applicable. There is no AI model or algorithm being trained for this medical device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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