The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation 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 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.

The liad™ 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 Kora™ 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.

Subject screws are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of smaller diameter cannulated screws to the spinal systems.

AI/ML Overview

This is a tough one! The provided text is a 510(k) premarket notification for spinal fixation systems (Zenius™, Iliad™, and Kora™). It describes the devices and their indications for use, and makes a claim of "substantial equivalence" to previously cleared predicate devices.

However, a 510(k) submission primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically involve a clinical study as would be described for an AI/ML device.

The "Performance Testing" section states: "Mechanical testing was performed per ASTM F1717 (Static and Dynamic Compression Bending, Tensile Bending, Static Torsion) to establish that the mechanical properties of the subject devices are equivalent to the predicate devices."

This is bench testing for mechanical properties, not a study involving patient data, ground truth establishment, or expert readers, which are the typical elements requested in your prompt for AI/ML device performance.

Therefore, many of the requested items (sample sizes, data provenance, ground truth, expert qualifications, MRMC studies, standalone studies, training set details) are not applicable to this type of device submission and the performance testing described.

Here's how I can address your request based on the provided text, highlighting the differences:

The provided document describes the Medyssey USA, Inc.'s Zenius™, Iliad™, and Kora™ Spinal Fixation Systems. This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to already marketed predicate devices, rather than proving efficacy through a de novo clinical study with patient data, ground truth, or human reader performance, as would be the case for an AI/ML device.

The performance testing described is mechanical (bench) testing, not a clinical study involving patient data. Therefore, many of the requested elements are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and performance are for mechanical properties tested against an industry standard, not diagnostic or clinical accuracy. The document states the goal was to "establish that the mechanical properties of the subject devices are equivalent to the predicate devices." It does not explicitly list numerical acceptance criteria or detailed results in the provided excerpt, but refers to ASTM F1717.

Acceptance Criteria Category	Specific Criteria (Implicitly based on ASTM F1717 & equivalence)	Reported Device Performance (Summary)
Mechanical Properties	Equivalence to predicate devices as defined by ASTM F1717 for:	Subject devices demonstrated mechanical properties equivalent to predicate devices.
	- Static Compression Bending Strength
	- Dynamic Compression Bending Endurance
	- Tensile Bending Strength
	- Static Torsion Resistance

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

Sample Size: Not specified in terms of patient data. The "test set" here refers to physical mechanical samples of the spinal fixation system components (rods, screws, etc.). The exact number of physical samples tested is not stated, but would typically follow ASTM F1717 guidelines.
Data Provenance: Not applicable in the context of patient data. The "data" comes from physical laboratory testing of manufactured devices.

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

Not Applicable. This is mechanical testing of physical devices, not a study evaluating human interpretation or diagnostic accuracy where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not Applicable. No human interpretation or clinical judgment requiring adjudication was involved in this mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of an AI/ML device on human reader performance in diagnostic tasks. This submission is for a physical spinal implant device and relies on mechanical bench testing.

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

Not Applicable. This device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable in the clinical/diagnostic sense. For mechanical testing, the "ground truth" is established by the standardized measurement methods and specifications outlined in ASTM F1717, which define how the mechanical properties (e.g., strength, endurance) are to be determined and compared.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

Summary

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

August 21, 2017

Medyssey USA, Inc. % Christine Scifert, MS Executive Vice President MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119

Re: K171526

Trade/Device Name: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 15, 2017 Received: August 16, 2017

Dear Ms. Scifert:

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 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 (DICE) 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 (DICE) 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, Katherine D. Kavlock -S for

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) K171526

Device Name

Zenius™, lliad™ and Kora™ Spinal Fixation Systems

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 - Special Zenius™, Iliad™ and Kora™ Spinal Systems May 24, 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:	ZeniusTM, IliadTM and KoraTM Spinal Fixation Systems
Common Name:	Pedicle Screw System
Classification:	Class II
Regulation Number:	21 CFR 888.3070 (Thoracolumbosacral Pedicle Screw Spinal System)
Panel:	87- Orthopedic
Product Code:	NKB

Predicate Devices:

Primary Predicate Device:

Medyssey: Iliad Pedicle Screws (formerly Novel) Kora Pedicle Screws (formerly Novel Standard . Buttress Thread Screw) Zenius Pedicle Screws Cobalt Chrome Rods – K121670(Cleared 1/25/2013)
Additional Predicate Devices:
Medyssey: Zenius Pedical Screws and Titanium Rods K093104 (Cleared 6/25/2000) and K103272 ● (Cleared 12/29/2010)
Medyssey: Novel Pedicle Screws and Titanium Rods K081153 (Cleared 1/30/2009), K103147 ● (Cleared 12/16/2010), and K110284 (Cleared 6/8/2011)

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Device Description:

Subject screws are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of smaller diameter cannulated screws to the spinal systems.

Indications for Use:

The Medyssey Co, Ltd. Zenius Spinal System is 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.

Substantial Equivalence:

The subject cannulated screws are substantially equivalent to the screws cleared in the following 510(k)s for the Zenius™, Iliad™ and Kora™ Systems with respect to indications for use, design, dimension, and materials.

Primary Predicate:

Medyssey: Iliad Pedicle Screws (formerly Novel) Kora Pedicle Screws (formerly Novel Standard Buttress Thread Screw) Zenius Pedicle Screws Cobalt Chrome Rods – K121670(Cleared 1/25/2013)

Secondary Predicate Devices:

Medyssey: Zenius Pedical Screws and Titanium Rods – K093104 (Cleared 6/25/2000) and K103272 (Cleared 12/29/2010)
Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cleared 1/30/2009), K103147 (Cleared 12/16/2010), and K110284 (Cleared 6/8/2011)

Performance Testing:

Mechanical testing was performed per ASTM F1717 (Static and Dynamic Compression Bending, Tensile Bending, Static Torsion) to establish that the mechanical properties of the subject devices are equivalent to the predicate devices. A summary of mechanical testing is provided in the Performance Testing -Bench section.

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.