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The Savannah-T® 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); spondylolisthesis; fracture; dislocation; scoliosis; 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 (L5-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 consists of pedicle screws, mono-axial and poly-axial screw heads, connecting rods, set screws, and transverse crossmembers, called the Savannah-Link. The screws are available in various diameters and lengths, and the rods are available in straight and curved versions in various lengths. The components are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Savannah-T® Pedicle Screw System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the mechanical tests. It only states that the testing was performed.
• Data Provenance: The data is from mechanical testing performed by the manufacturer (Amendia, Inc.) to support a 510(k) submission. It is a prospective study in the sense that the tests were conducted specifically for this submission. The origin is the U.S. (Amendia, Inc. is based in Marietta, GA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The "ground truth" for this device is established through adherence to industry-standard mechanical testing protocols (ASTM F1717-12) and a comparison to a predicate device. There are no human experts "reading" images or determining outcomes in a clinical sense. The experts involved would be the engineers and technicians performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) summary. The comparison is against established mechanical standards and to a predicate device's performance.

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 information is not applicable. The Savannah-T® Pedicle Screw System is a physical implantable medical device, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is primarily:

• Performance against established Mechanical Testing Standards: Specifically, ASTM F1717-12 for static compression bending, static torsion, and dynamic compression bending.
• Performance relative to a Legally Marketed Predicate Device: The Savannah Lumbar Percutaneous Stabilization System (SLPSS) (K072116). The "ground truth" here is the established safety and effectiveness of the predicate.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for it. The analogous concept would be the design specifications and material properties of the pedicle screw system, which are based on engineering principles and regulatory standards.

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