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Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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; pseudarthrosis; and/or failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The Spinal Inner Fixation System is a medical device system for surgical fixation of the spine. It is made up of pedicle screws, set screw, rods and cross connecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implants are single-use. The surgical instruments may be reprocessed and re-used. The Spinal Inner Fixation System includes model GB1Z-I and GB1Z-II according to the rod diameter, and each model comprises of different length rods, various length and diameter screws, set screws and accessories. Both models are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option. Surgical instruments are provided with the device system.

I am sorry, but the provided text from the FDA 510(k) K222031 does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of AI/algorithm performance.

The document discusses a "Spinal Inner Fixation System," which is a medical device for surgical fixation of the spine, made up of mechanical components like pedicle screws, rods, and connectors.
The "Performance - Bench" section mentions bench performance testing completed according to ASTM F1717-18 standards, including static compression bending, dynamic compression bending, and static torsion. This information pertains to the mechanical properties of the physical device, not the performance of an AI or algorithmic medical device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for test sets or data provenance for an AI/algorithm.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication methods for an AI/algorithm test set.
5. MRMC comparative effectiveness studies or effect sizes for human readers with and without AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for an AI algorithm.
8. Sample size for a training set for an AI algorithm.
9. How ground truth for a training set was established for an AI algorithm.

The K222031 document is a 510(k) summary for a mechanical orthopedic implant, not an AI-powered medical device.

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