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The Savannah-T® Pedicle Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:

· When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scollosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).

• In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.

The Savannah-T® Pedicle Screw System provides structural stability in skeletally mature adults requiring fusion of the lumbar and/or sacral spine. The system consists of mono- and poly-axial pedicle screws, connecting rods, set screws, and transverse crossmembers. The screws are available in cancellous and cortical-cancellous thread designs of various diameters and lengths. The rods are available in straight, lordosed and pre-contoured confiqurations in various lengths. They are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for single-use.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Savannah-T® Pedicle Screw System and a 510(k) summary. This document does not describe a clinical study or acceptance criteria for a device's performance in terms of diagnostic accuracy or effectiveness against specific clinical outcomes.

Instead, this document focuses on establishing substantial equivalence for a medical implant device (a pedicle screw system) to previously cleared devices. The acceptance criteria and performance data discussed are related to mechanical testing of the device, not a study evaluating its use in patients or comparing its diagnostic capabilities.

Therefore, many of the requested points in your prompt are not applicable to the information contained in this document. I will answer what can be gleaned from the text provided.

1. A table of acceptance criteria and the reported device performance

The document mentions "non-clinical mechanical testing" as the basis for demonstrating substantial equivalence. The specific acceptance criteria are not detailed in terms of numerical thresholds here, but the overall goal is for the device to perform comparably to predicate devices.

Disclaimer: The document does not provide specific numerical acceptance limits or results, only that the device met the criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This refers to the number of devices or test articles subjected to mechanical testing. The document states, "Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device." This implies a limited number of test articles, often representing the most challenging configuration in a product family, rather than a broad sample size typically associated with clinical studies. The actual number of "worst-case" devices isn't specified, but it would typically be a small, statistically valid number for engineering testing.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. These are non-clinical (laboratory) tests. The terms "retrospective" or "prospective" do not apply to this type of mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome usually established by medical experts or pathology. For mechanical testing of an orthopedic implant like a pedicle screw system, the "ground truth" is measured against engineering standards (e.g., ASTM F1717), and the performance is assessed by engineers and materials scientists, not medical experts establishing clinical diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among human readers or evaluators in establishing ground truth. Mechanical testing relies on objective physical measurements and engineering analysis, not subjective interpretation of clinical data by multiple experts.

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 question is not applicable. An MRMC study assesses the performance of human readers, often aided by AI, in tasks like interpreting medical images. The Savannah-T® Pedicle Screw System is a physical implant, not an AI diagnostic tool, and the submission primarily concerns its mechanical safety and effectiveness.

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

This question is not applicable. This refers to the performance of an AI algorithm independently. The Savannah-T® Pedicle Screw System is a physical device, and its evaluation did not involve a standalone algorithm performance test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically understood in clinical or AI diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For mechanical testing, the "ground truth" or reference performance is established by the requirements of the recognized standards (e.g., ASTM F1717) and the performance of the predicate device. The performance of the subject device is then compared against these established mechanical benchmarks.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI algorithm or a statistical model. The Savannah-T® Pedicle Screw System is a physical implant, and its evaluation did not involve a training set as described for AI or machine learning.

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

This question is not applicable. As there was no training set in the context of AI or machine learning for this physical device, there was no ground truth established for such a set.

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