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The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The DePuy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The DePuy Pulse Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.
The DePuy Pulse Thoracolumbar Screw System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Pulse Thoracolumbar Screw System:

This device is not an AI/ML device, but a physical medical device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance on device components, not a test set of data.

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 physical medical device, and the "ground truth" for mechanical testing is defined by the ASTM F-1717 standard's specifications.

4. Adjudication method for the test set

Not applicable. This is a physical medical device, and mechanical test results are typically objective measurements against a standard, not subject to expert adjudication.

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

No. This is a physical medical device, not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.

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

No. This is a physical medical device, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified mechanical testing standards (ASTM F-1717) for spinal implant constructs. These standards define the acceptable mechanical properties and behaviors under various loads.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set with established ground truth.

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