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The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac serew fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patiens. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac serew fixation system, or as an anterolateral fixation system.

The provided text describes a 510(k) premarket notification for the EBI® Array® Spinal System. This submission is for a medical device (spinal fixation system), not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, standalone performance) is not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing.

Here's a breakdown of the relevant information from the provided text:

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

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

• Not applicable for this type of submission. This submission is for a spinal fixation device, relying on mechanical testing to demonstrate substantial equivalence, not the analysis 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):

• Not applicable. Ground truth in this context would refer to material properties and mechanical behaviors, established through standardized engineering tests, not clinical expert consensus on images or diagnoses.

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

• Not applicable. Adjudication methods are relevant for clinical interpretations, not mechanical testing. Mechanical tests have objective, measurable outcomes.

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 submission is not for an AI-assisted diagnostic device.

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

• Not applicable. This submission is not for an AI algorithm.

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

• The "ground truth" for this device's performance is established by engineering design specifications and standards for mechanical properties and structural integrity of spinal fixation devices, derived from predicate devices. The tests measure objective physical properties and behaviors under defined loads.

8. The sample size for the training set:

• Not applicable. This submission does not involve a training set for an AI model.

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

• Not applicable. This submission does not involve a training set for an AI model.

Summary of the Study (Mechanical Performance Testing):

The device's performance was evaluated through mechanical testing. This testing was conducted to demonstrate that the expanded line of the Array® Spinal System conforms to its design specifications, which were themselves based on the design requirements of previously cleared predicate devices. The study focused on demonstrating that "the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance." The conclusion was that "these technological differences do not present any new issues of safety or effectiveness."

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