(146 days)
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
| Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Testing Standards: | Results: |
| Static Compression Bending (in accordance with ASTM F1717-12) | "Results of these tests showed the Savannah-T® to be better or equivalent to the predicate device." |
| Static Torsion (in accordance with ASTM F1717-12) | "Results of these tests showed the Savannah-T® to be better or equivalent to the predicate device." |
| Dynamic Compression Bending (in accordance with ASTM F1717-12) | "Results of these tests showed the Savannah-T® to be better or equivalent to the predicate device." |
| Substantial Equivalence to Predicate Device: | Conclusion: |
| Same "Indications for Use" as predicate device (K072116) | "Both devices have the same 'Indications for Use'..." |
| Available by prescription only | "...are available by prescription only..." |
| Provided non-sterile for single-use only | "...and are provided non-sterile for single-use only." |
| Differences do not negatively impact safety and effectiveness | "These differences do not negatively impact the overall safety and effectiveness of the device, and this was verified via mechanical testing." |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.