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The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:

Posterior non-cervical fixation as an adjunct to fusion 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; pseudoarthosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.

The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.

The provided text is a 510(k) summary for the "Cannulated Power Driver Attachment". This document is for a medical device that assists in the surgical insertion of pedicle screws, not an AI/ML-driven device for diagnosis or prediction. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable.

However, I can extract information related to the acceptance criteria and how the device met them.

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

The document states that the "Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device." It further states: "The performance of the Cannulated Power Driver Attachment has met all acceptance criteria."

While specific numerical acceptance criteria (e.g., torque values, cycles to failure) are not provided in this summary, the general acceptance criteria can be inferred from the context of "substantial equivalence" and "verification and validation activities."

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

This device is a mechanical instrument. Testing would involve engineering evaluations (e.g., mechanical stress tests, fatigue tests) rather than data from human subjects or medical images. Therefore, the concepts of "test set sample size" and "data provenance" as typically applied to AI/ML systems are not relevant here. The "test set" would be the manufactured Cannulated Power Driver Attachment instruments subjected to various non-clinical performance evaluations. The number of units tested is not specified.

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)

This is not applicable as the device is a mechanical instrument. Ground truth in this context would be defined by engineering standards and specifications, not expert medical opinion on clinical data.

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

Not applicable for a mechanical device.

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 as this is a mechanical medical instrument, not an AI/ML diagnostic or predictive tool.

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

Not applicable as this is a mechanical medical instrument, not an AI/ML algorithm.

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

The "ground truth" for a mechanical device would be established by engineering specifications, validated test methods, and performance benchmarks against predicate devices. The summary indicates that "Verification and validation activities" were conducted to demonstrate that the device "met all acceptance criteria" and "does not represent a new worst case for powered pedicle screw insertion," implying a comparison to established performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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