The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

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)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Scoliosis
Lordotic deformities of the spine
Spinal stenosis
Failed previous spine surgery

Device Description

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called the "Z-Span Plate System." This document is a regulatory approval notice from the FDA, not a research study report with detailed acceptance criteria and performance data in the context of a clinical trial or AI model evaluation.

Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and ground truth are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Mechanical Testing:	Mechanical Testing:
Static Axial Compression Bending (ASTM F1717)	Performs as well as or better than the predicate device.
Dynamic Axial Compression Bending (ASTM F1717)	Performs as well as or better than the predicate device.
Static Torsion Testing (ASTM F1717)	Performs as well as or better than the predicate device.

Note: The specific quantitative acceptance criteria (e.g., minimum load, fatigue cycles) and the exact performance values are not provided in this summary. It only states that the device "performs as well as or better than" the predicate device based on ASTM F1717 standards.

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

This information is not provided in the document. The testing mentioned is mechanical testing, not a clinical study on human subjects with a "test set" in the sense of patient data.

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 information is not applicable/not provided. The "ground truth" here refers to the performance of the device in mechanical tests, which is measured objectively, not adjudicated by experts in the context of clinical outcomes.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials. Mechanical testing results are objective measurements.

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. This device is a spinal implant, not an AI diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the mechanical testing is the objective measurement of the device's physical properties and performance against established ASTM F1717 standards, and comparison to the predicate device's performance under those same standards.

8. The sample size for the training set

This information is not applicable/not provided. This is not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided. There is no "training set" for this physical device.

Summary

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

March 22, 2016

Zavation, LLC Mr. Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K160362

Trade/Device Name: Z-Span Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 8, 2016 Received: February 9, 2016

Dear Mr. Cummins:

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) K160362

Device Name Z-Span Plate System

Indications for Use (Describe)

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

· 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)

· Pseudoarthrosis
· Spondylolysis
· Spondylolisthesis
· Scoliosis
· Lordotic deformities of the spine
· Spinal stenosis
· Failed previous spine surgery

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)

|X Prescription Use (Part 21 CFR Subbart Di ounter Use (21 CFR 801 Suppart C)

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510K Summary

Date:	Feb 08, 2016
Submitter:	Zavation, LLC220 Lakeland ParkwayFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Frankie Cummins
Type of 510(k) submission:	Traditional
Trade name:	Z-Span Plate System
Common Name:	Spinal Fixation System
Classification regulation/code:	888.3060, KWQ
Classification name:	Spinal Intervertebral Body Fixation Orthosis
Device classification:	Class II
Classification Panel:	Orthopedic
Basis for submission:	New device

Device Description:

Indications for Use:

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

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The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

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)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Scoliosis
Lordotic deformities of the spine
Spinal stenosis ●
. Failed previous spine surgery

Predicate Device:

Primary: Synthes, Antegra System (K063158) Additional: Orthofix, Skyhawk Plate System (K140260)

Technological Characteristics:

The technological characteristics including material, design and performance of the Z-Span Plate System are consistent with those of the predicate devices.

Performance Data:

Mechanical testing of the Z-Span Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717. Test results demonstrate that the Z-Span Plate System performs as well as or better than the predicate device and is therefore substantially equivalent to the predicate devices.

Conclusion:

Based on the similarities in materials, design, principles of function, intended use and indications, the Z-Span Plate system has been shown to be substantially equivalent to the predicate devices. Non-clinical data demonstrates the Z-Span Plate System is as safe, as effective, and performs as well as the predicate devices. The Z-Span Plate System does not raise new safety and effectiveness questions.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.