Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the ittachment of a solid fusion.

Mikron Spinal Fixation System is also intended to provide immobilization 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: Degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The Proposed Device is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods (Straight and pre-bent) and setscrews. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Mikron Spinal Fixation System. This type of submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of clinical study typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the information required to answer your questions regarding acceptance criteria and performance studies for an AI/SaMD product (such as a table of accuracy, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

This document details:

The device's intended use (spinal fixation)
Its material (titanium alloy)
Its design (pedicle screws, rods, setscrews)
Its technological characteristics compared to predicate devices
Non-clinical performance testing: static compressive, torsion, and dynamic compressive tests according to ASTM F1717; torsion and pullout tests for screws according to ASTM F543; axial and torsional gripping capacity according to ASTM F1798; and static and dynamic 4-point bending according to ASTM F2193. These are mechanical tests to ensure the physical properties and strength of the implant, not a study of algorithm performance.
Risk Analysis.

The key takeaway is that for a traditional hardware medical device like a spinal fixation system, "acceptance criteria" are typically met through mechanical and material testing to established industry standards (e.g., ASTM standards) and comparison to predicate devices, rather than the kind of clinical performance study with human readers and ground truth data that would be relevant for an AI/SaMD product.

In summary, the document does not contain the information needed to answer the specific questions about AI/SaMD acceptance criteria and study data.

Summary

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October 12, 2017

Mikron Makina Sanayi Ticaret Co. Ltd. Mr. Mesut Köse International Marketing Manager Agac Isleri Sanayi Sitesi 1372. Sokak No: 31-Ostim Ankara 06378 Turkey

Re: K171497

Trade/Device Name: Mikron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 13, 2017 Received: July 17, 2017

Dear Mr. Köse:

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 Part 801); medical device reporting of medical device-related 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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,

Ronald P. Jean - $S_{for}$

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) K171497

Device Name

Mikron Spinal Fixation 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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K171497 Page 1 of 4

Section 3

510(k) Summary (as required by 21 CFR 807.92)

3.1 Owner/Submitter Information

Owner:	Mikron Makina Sanayi Ticaret Co. Ltd.
Address:	Agac Isleri Sanayi Sitesi 1372. Sokak No: 31-OstimAnkara / Turkey 06378
Phone:	90.312.395 1700
Fax:	90.312.395 8729
Contact Person:	Mesut Köse (Phone: 90.532.441 8629)
Date Prepared:	11 October 2017

3.2 Device Information

Common Name:	Orthosis, Spinal Pedicle Fixation
Trade Name:	Mikron Spinal Fixation System
Classification name:	Thoracolumbosacral Pedicle Screw System(per 21 CFR 888.3070)
Device Panel:	Orthopedic
Product codes:	NKB

ll Proposed Class:

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3.3 Substantial Equivalence

The proposed device is substantially equivalent to the device with the same trade name, Mikron Spinal Fixation System, which was FDA-cleared via 510(k) K130073, and BK Meditech's "MEGA 5.5 System" (K123476) -referred to as "Additional Predicate". These devices have the same intended use, technological characteristics and basic design as the proposed device. The only changes to Mikron Spinal Fixation System are new sizes and shapes added to the product span (i.e., addinq various sizes of screws, and different size and shapes (straight and pre-bent) of rods).

3.4 Device Description

3.5 Indications for Use

Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.

Mikron Spinal Fixation System is also 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: Degenerative spondylolisthesis with objective

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evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

3.6 Technical Comparison

The summary of the technological characteristics of The Proposed Device compared to the predicate devices is as follows:

3.6.1 Material

All subject devices are fabricated of the same material, which is titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

3.6.2 Design

The Proposed Device and Predicate Devices have similarly designed but different sized screws and different sized and shaped (Straight and Pre-bent) rods. They both have same top-loading interconnection mechanism with same setscrew. The design incorporates the same design features as the predicate over new lengths and diameters to create a complete range of sizes for the surgeon. The system is attached to the vertebral body by means of screws at the non-cervical spine.

3.6.3 Function

All subject devices have the same function, which is acting as a spinal implant construct to stabilize and promote spinal fusion.

3.6.4 Level of Attachment

Levels of fixation of the Proposed and the Predicate Devices are for the thoracic, lumbar and sacral spine.

3.6.5 Intended Use

The Proposed Device is indicated for the identical intended uses as the predicate devices:

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All devices are indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion. Mikron Spinal Fixation System is also 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

3.6.6 Sterility

All devices are supplied non-sterile and for single use.

3.7 Non-Clinical Performance Testing

Non-clinical testing including static compressive, static torsion and dynamic compressive tests according to ASTM F1717, torsion test and pullout test for screws according to ASTM F543, axial gripping capacity and torsional gripping capacity according to ASTM F1798 and static and dynamic 4-point bending according to ASTM F2193 were conducted. The results demonstrate that the Proposed Device is substantially equivalent to the legally marketed predicate devices.

A Risk Analysis was also prepared and showed that the proposed changes do not present any additional risks.

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.