The Medyssey Co, Ltd. Iliad and Zenius Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Iliad™ Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients.

Subject rod connectors are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of hook type rod connectors to the Iliad™ and Zenius™ Systems.

AI/ML Overview

This is a medical device application for a spinal screw system, not an AI/ML powered device. As such, the requests for specific AI/ML study information (like sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document. The document describes a traditional medical device (pedicle screw system) and its performance testing to demonstrate substantial equivalence to a predicate device.

Here's the relevant information from the provided text, focused on the device's acceptance criteria and the study proving it, as much as possible given the nature of the device:

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

Acceptance Criteria (Proxy)	Reported Device Performance
Mechanical properties equivalent to predicate devices as per ASTM F1798-13	Passed Axial grip testing per ASTM F1798-13, demonstrating substantial equivalence to predicate devices.

Explanation: For a mechanical device like a pedicle screw system, "acceptance criteria" are typically related to meeting established mechanical and material standards, and demonstrating equivalent performance to a legally marketed predicate device. The document explicitly states the objective was to show substantial equivalence through mechanical testing according to a specific ASTM standard.

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

Sample Size: Not explicitly stated in terms of a "test set" as would be for AI/ML. For mechanical testing, samples refer to the physical devices tested. The document does not specify the number of devices tested.
Data Provenance: Not applicable in the context of clinical data provenance. The "data" here refers to mechanical test results of physical devices.

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)

Not applicable. This is not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from clinical cases. The "ground truth" for a mechanical device is adherence to engineering standards and performance specifications.

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

Not applicable. This is not an AI/ML diagnostic or prognostic device requiring adjudication of expert interpretations.

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

Not applicable. This is not an AI-assisted diagnostic or prognostic device.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" equivalent for this device is the performance observed under established mechanical testing standards (ASTM F1798-13), demonstrating that the device's mechanical properties are equivalent to the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for a mechanical device.

Summary

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Public Health Service

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

June 12, 2017

Medyssey USA, Inc. % Kim Strohkirch. MS. MEM Executive Vice President MRC-X. LLC 6075 Poplar Ave Memphis. TN 38119

Re: K171509

Trade/Device Name: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: May 22, 2017 Received: May 23, 2017

Dear Ms. Strohkirch:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.

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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)

K171509

Device Name

Illiad® Pedicle Screw System and Zenius® Pedicle Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - Special Iliad® and Zenius® Spinal Systems

May 22, 2017

Company:	Medyssey USA, Inc.1550 East Higgins Road, Suite 123,Elk Grove Village, IL 60007U.S.A.Tel: 1-847-427-0200FAX: 1-888-518-9070
Primary Contact:	Kim StrohkirchPhone: 901-361-2037
Company Contact:	Shawn Kim, DirectorMedyssey USA
Trade Name:	Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
Common Name:	Pedicle Screw System
Classification:	Class II
Regulation Number:	21 CFR 888.3070 (Thoracolumbosacral Pedicle Screw System)
Panel:	87- Orthopedic
Product Code:	NKB

Predicate Devices:

Primary Predicate Device:

. Medyssey: Iliad Pedicle Screw System and Zenius Pedicle Screw System-K142835 (Cleared 6/12/2015)

Device Description:

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sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients.

Subject rod connectors are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of hook type rod connectors to the Iliad™ and Zenius™ Systems.

Indications for Use:

The Medyssey Co, Ltd. Iliad and Zenius Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Substantial Equivalence:

The subject cannulated screws are substantially equivalent to the screws cleared in the following 510(k)s for the Iliad™ and Zenius™ Systems with respect to indications for use, dimension, and materials. The subject connectors differ from the predicate connector in design. The subject connectors are open; predicate connectors are closed. Mechanical testing demonstrates that the subject device is substantially equivalent to the predicate device.

Primary Predicate Device:

. Medyssey: Iliad Pedicle Screw System and Zenius Pedicle Screw System-K142835 (Cleared 6/12/2015)

Performance Testing:

Axial grip testing was performed per ASTM F1798-13 to establish that the mechanical properties of the subject devices are equivalent to the 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.