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The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:

• Defect of the pars interarticularis .
• Spondylolithesis .

The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.

Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.

The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:

• Defect of the pars interarticularis .
• Spondylolithesis .

The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.

Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.

The provided text describes a 510(k) summary for the Pioneer Posterior Cable Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and standalone performance evaluations as would be expected for novel devices or software.

Therefore, much of the requested information regarding acceptance criteria, specific study details (sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document, as it falls outside the scope of a typical 510(k) summary focused on hardware equivalence.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable/Not Provided. The submission is for a mechanical spinal implant and focuses on substantial equivalence based on material and mechanical properties, not a clinical study on a test set of data (e.g., images for an AI device).
• Data Provenance: Not applicable. Performance is based on material standards and mechanical testing, not a dataset from a specific country or retrospective/prospective study with human subjects.

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

• Not Applicable/Not Provided. This information is relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.

4. Adjudication method for the test set

• Not Applicable/Not Provided. No test set requiring expert adjudication is described.

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 hardware device (spinal implant), not a software/AI device. Therefore, an MRMC study is not relevant or described.

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

• Not Applicable. This is a hardware device. "Standalone performance" in the context of AI algorithms is not relevant here. The "standalone" performance would be its mechanical integrity, which is assessed through testing that is not detailed in terms of its specific methodology or standalone vs. human-in-the-loop comparison.

7. The type of ground truth used

• Not Applicable/Not Provided in the typical AI/clinical study sense. For this device, "ground truth" relates to:
  • Material composition: Confirmed by adherence to ASTM F138 and ISO 5832-1 standards.
  • Mechanical performance: Confirmed through testing (implied by "Mechanical information was presented") against accepted engineering criteria, likely benchmarking against the predicate device.
  • Clinical Efficacy/Safety: Not directly proven in this 510(k) summary; rather, it is inferred by substantial equivalence to a device with an established safety and efficacy profile.

8. The sample size for the training set

• Not Applicable/Not Provided. This pertains to AI/machine learning models, which is not the subject of this 510(k). For mechanical testing, the number of samples tested for mechanical properties is not specified.

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

• Not Applicable/Not Provided. As there's no AI "training set" described, this question is not relevant. The "ground truth" for the device's material and mechanical properties would be established through accredited laboratory testing and adherence to recognized material and performance standards.

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