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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Reported Device Performance
Mechanical Testing	Demonstrated substantial equivalence to the predicate device. Specific tests included: Static/dynamic axial compression (ASTM F1717) Static torsion (ASTM F1717) Secondary bending testing (dynamic compression, ASTM F1717)

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 8, 2016

Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K152920

Trade/Device Name: Savannah-T® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 17, 2016 Received: June 20, 2016

Dear Ms. Allen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152920

Device Name Savannah-T® Pedicle Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
❌ Prescription Use (Part 21 CFR 801 Subpart D)	❍ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Savannah-T® Pedicle Screw System

Submitter:	Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062
Contact Person:	Kristen AllenSr. Regulatory Affairs Specialist910-612-4153 (P), 877-420-1213 (F)kallen@amendia.com (e-mail)
Date Prepared:	June 17, 2016
Trade Name:	Savannah-T® Pedicle Screw System
Common Name:	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Device Product Codeand Classification:	Regulation Number: 21 CFR 888.3070MNH, Class II, Spondylolisthesis Spinal Fixation Device SystemMNI, Class II, Pedicle Screw Spinal SystemNKB, Class III, Pedicle Screw Spinal System, For DegenerativeDisc Disease
Primary Predicate Device:	Savannah-T® Pedicle Screw System (K132925)

Talon Spinal System (K102995) Additional Predicate:

Purpose of Submission: This special 510(k) is intended to gain clearance for addition of precontoured fixation rods to the Savannah-T® Pedicle Screw System.

Device Description:

Indications and Intended use:

The Savannah-T® Pedicle Screw System is intended to provide immobilization and stabilization 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

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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 lumbarfirst 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.

Summary of Technological Characteristics:

The subject devices are substantially equivalent to the predicate device as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device is identical to the predicate in regards to technological characteristics including design, intended use, material composition, and function.

Summary of Performance Testing:

Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device. Testing included static/dynamic axial compression and static torsion (ASTM F1717), as well as secondary bending testing (dynamic compression, ASTM F1717). Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.

Conclusion:

Based on the comparison to predicate devices, the Subject Device has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 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.