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The Pioneer Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Pioneer Lateral Plate System consists of an assortment of plates and screws manufactured from ASTM F136 Titanium Alloy.

The provided document describes a Pioneer Lateral Plate System, a medical device used for spinal fixation. This is a mechanical device, not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested categories related to AI/ML studies (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and will not be found in the document.

The performance data for this type of device focuses on mechanical testing and demonstrating substantial equivalence to predicate devices based on physical characteristics and intended use.

Here's the information extracted from the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the test results demonstrate the device "functioned as intended and performed in a manner substantially equivalent to that of predicate systems." It does not provide specific numerical thresholds for acceptance or numerical results for the performance, as is common for substantial equivalence claims based on established ASTM standards for mechanical devices.

Information Not Applicable or Not Found in the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a spinal implant. The "test set" here refers to the physical devices subjected to mechanical stress tests, not a dataset of patient information.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is defined by the physical properties and performance against ASTM standards, not by expert interpretation of data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 for a mechanical spinal implant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the specifications of the ASTM standards and the physical properties of the materials and design.
7. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
8. How the ground truth for the training set was established: Not applicable.

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