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The ISOLA Spinal System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.

The ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 4.75mm and 6.35mm spinal rods of the ISOLA Spinal System

The provided text is a 510(k) summary for the CrossOver Cross Connector. It describes the device, its intended use, and indicates that performance data was submitted, but it does not explicitly detail acceptance criteria or the specific study that proves the device meets those criteria, especially in a way that aligns with AI/ML device testing standards.

The document is from 2002, which predates the widespread use of AI/ML in medical devices and the associated regulatory requirements for describing AI/ML performance evaluation studies. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for test/training sets, expert adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of regulatory submission.

Based on the information provided, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not applicable/Not provided. The "performance data" mentioned likely refers to mechanical testing or other non-clinical evaluations rather than a clinical "test set" in the context of AI/ML.
• Data provenance: Not applicable/Not provided.

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

• Not applicable. This device is a mechanical implant; it does not involve expert interpretation for establishing a ground truth in the way an AI/ML diagnostic or prognostic device would.

4. Adjudication method for the test set:

• Not applicable.

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 mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used:

• For a mechanical device like this, ground truth would typically relate to established engineering standards (e.g., material strength, fatigue life, mechanical stability) and biomechanical testing results rather than clinical "ground truth" derived from patient outcomes or expert consensus. The document does not specify the exact nature of the performance data, but it likely involved bench testing confirming structural integrity and biomechanical properties.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm.

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

• Not applicable.

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