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The SpineFrontier® PedFuse® Pedicle 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 the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screw assemblies, and cross connectors.

This document is a 510(k) summary for a medical device called the "PedFuse® Pedicle Screw System," specifically for the addition of a sliding washer component. It is a regulatory submission for substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically associated with studies demonstrating AI or diagnostic device performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). This document primarily focuses on demonstrating that the new component (sliding washer) does not change the fundamental safety and effectiveness of the existing device and remains substantially equivalent to already cleared devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission and device.

However, I can extract information related to the device itself and its regulatory context:

• Device Name: PedFuse® Pedicle Screw System
• Manufacturer: SpineFrontier®
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNH, MNI
• Indications for Use: The SpineFrontier® PedFuse® Pedicle 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 instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis). It is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).
• Change from Previous System: Addition of a sliding washer.
• Material: Medical grade titanium alloy (ASTM F136).
• Predicate Devices: K133153, K123164, K092420 (SpineFrontier Pedfuse® Pedicle Screw System) and K071420 (Chameleon® FacetFuse® MIS Screw System as a reference).

Regarding your specific questions, based on the provided text, I can state the following:

1. Table of acceptance criteria and the reported device performance: Not applicable. This document is not about performance metrics like sensitivity or accuracy. It's about substantial equivalence for a hardware component.
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. This document does not detail a test set for performance evaluation in the context of diagnostic or AI devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is not relevant for this type of hardware component submission.
4. Adjudication method: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device component, not a study evaluating performance against specific acceptance criteria for a diagnostic or AI-driven device.

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