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The BridgePoint™ Spinous Process Clamp System is a posterior, non-pedicle supplemental fixation device, intended for use in non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. It is not intended for stand alone use.

The BridgePoint™ Spinous Process Clamp- Posterior Fixation System is an implantable device that clamps bilaterally to the spinous processes. It is a multi-component device consisting of two sets of plates. Each set is composed of a male and female plate. Two sets are coupled by two rigid posts that connect and pivot at the midline. The plates have a male and female component which slide and result in a variable plate length. These sliding plates are locked by a lateral set screw.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

BridgePoint™ Spinous Process Clamp- Posterior Fixation System

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for AI/ML evaluation. The performance evaluation was entirely based on nonclinical mechanical testing. Therefore, information regarding:

• Sample size for a test set
• Data provenance (country of origin, retrospective/prospective)
  is not applicable as this was a physical device that underwent laboratory testing.

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

This is not applicable. Ground truth for mechanical testing is established through standardized testing protocols (e.g., ASTM standards) and measurements, not expert consensus in the medical image interpretation sense. The "experts" are likely engineers and technicians performing and analyzing the mechanical tests.

4. Adjudication method for the test set

This is not applicable as the evaluation involved objective mechanical testing, not subjective human assessment needing 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

This is not applicable. The device is an implantable medical device, not an AI/ML diagnostic or assistive technology. Its effectiveness is evaluated through biomechanical performance, not enhancement of human "readers."

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

This is not applicable as there is no algorithm involved. The device is a physical, implantable medical product.

7. The type of ground truth used

The ground truth used was mechanical testing results based on recognized consensus standards and guidance documents (e.g., Spinal System 510(k)s - Guidance for Industry and FDA Staff). This involves objective measurements of static and fatigue performance characteristics.

8. The sample size for the training set

This information is not applicable. This submission pertains to a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The design and development of the device would have involved engineering principles and potentially iterative physical testing, but not a data-based training set as seen in AI/ML.

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

This is not applicable for the same reasons as point 8. The "ground truth" for the device's design and engineering would stem from biomechanical principles, material science, and relevant industry standards for spinal implants.

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