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The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),

• trauma (i.e., fracture or dislocation),

• spinal stenosis, ·

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.
  The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis.

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.

The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.

The Malibu™ Spinal System with the Daytona™ Deformity System is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training set, test set, effect size, etc.) are not applicable.

This device is a Pedicle Screw Spinal System and a Spinal Interlaminal Fixation Orthosis, which are hardware components (spinal rods and pedicle screws) used in spinal fusion procedures. The submission is a "Special 510(k)" for line extensions.

Here's the information based on the provided document:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. The performance testing was based on mechanical testing of the devices themselves, comparing them to predicate devices.
• Data Provenance: The testing was mechanical/bench testing according to ASTM standards (F1717 and F1798) comparing the new device designs to existing predicate devices. This is laboratory-based data, not human patient data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring expert consensus for image or clinical data.

4. Adjudication method for the test set:

• Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring adjudication of clinical or image data.

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:

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML algorithm.

7. The type of ground truth used:

• For mechanical performance, the "ground truth" is established by the performance characteristics of legally marketed predicate devices and the requirements of recognized industry standards (ASTM F1717 and F1798). The new devices are shown to be "equivalent" in these mechanical tests to their predicates.

8. The sample size for the training set:

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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