Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Device Description

Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the "Spinal Inner Fixation System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets a specific set of acceptance criteria for diagnostic performance or treatment efficacy in the way an AI/ML device would.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance for AI/ML systems is not applicable or present in this document.

However, I can extract the information relevant to the mechanical performance testing conducted for this orthopedic device.

Here's the breakdown of the available information:

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

The document does not explicitly state numerical acceptance criteria for mechanical tests. Instead, it compares the proposed device's performance to that of the predicate device within the context of the testing standard ASTM F1717. The acceptance is based on the results showing no statistically significant difference between the proposed device and the predicate device for various mechanical properties.

Specification	Acceptance Criteria (Implied)	Reported Device Performance
Static compression bending: yield load	Similar to predicate, no statistically significant difference	Similar, the testing results show no statistically significant difference between two samples groups
Static compression bending: stiffness	Similar to predicate, no statistically significant difference	Similar, the testing results show no statistically significant difference between two samples groups
Dynamic compression bending	Similar to predicate, no statistically significant difference	Similar, the testing results show no statistically significant difference between two samples groups
Static torsion: torque	Similar to predicate, no statistically significant difference	Similar, the testing results show no statistically significant difference between two samples groups
Static torsion: torsional stiffness	Similar to predicate, no statistically significant difference	Similar, the testing results show no statistically significant difference between two samples groups
Materials	Conforms to ASTM F136 (TiAl4V ELI)	Titanium alloy (TiAl4V ELI) which conforms to ASTM F136
Biocompatibility	Conforms to ASTM F136 (TiAl4V ELI)	Titanium alloy (TiAl4V ELI) which conforms to ASTM F136
Sterility	Provided as non-sterile, requires steam sterilization	Provided as non-sterile, needs steam sterilization prior to use
Dissociation testing of screw head	(Not explicitly stated, but assumed to meet design specs based on overall conclusion)	Performed (stated but no specific result given, implied satisfactory)

2. Sample size used for the test set and the data provenance

The document refers to "two samples groups" for the mechanical testing, but the specific numerical sample sizes are not provided. The data provenance is testing conducted by the applicant, Changzhou Dingjian Medical Appliance Co., Ltd., likely in China, as it is the country of origin for the submitter. This is a bench test, not clinical data, so the concepts of retrospective or prospective data as typically applied to patient studies are not applicable.

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 is not applicable as this is a mechanical testing study, not a study involving human interpretation or ground truth establishment by experts in the context of diagnostic performance.

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

This is not applicable for mechanical testing.

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 is not applicable as this is a mechanical orthopedic device, not an AI/ML diagnostic or assistive device.

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

This is not applicable as this is a mechanical orthopedic device.

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

For mechanical testing, the "ground truth" or reference standard would be the established testing methodology and performance characteristics defined by the ASTM F1717 standard and the performance of the legally marketed predicate device. The comparison is made against the predicate device's measured performance in these standardized tests.

8. The sample size for the training set

This is not applicable as this is a mechanical testing study, not an AI/ML study involving a training set.

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

This is not applicable as this is a mechanical testing study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

Changzhou Dingjian Medical Appliance Company, Limited % Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Company, Limited 7th Floor, Jingui Business Building, 982 Congyun Road Baiyun District, Guangzhou, Guangdong, 510420 CHINA

December 11, 2015

Re: K143013

Trade/Device Name: Spinal Inner Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: November 16, 2015 Received: November 24, 2015

Dear Mr. Gu:

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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Page 2 – Mr. Mike Gu

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/Resourcesfor You/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 vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143013

Device Name Spinal Inner Fixation 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: l. SUBMITTER

Changzhou Dingjian Medical Appliance Co., Ltd.

No. 19 Juxiang Road

Wujin Economic Development Zone

Changzhou, Jiangsu Province, 213149, China

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6232 1333
	Fax: (+86) 20-8633 0253

Secondary Contact Person:	Li Qingsong
	Changzhou Dingjian Medical Appliance Co., Ltd.
	Tel: 0086-13584330156
	Fax: 0086-519-89603573

Date Prepared:	October 05, 2014
II. DEVICE
Name of Device:	Spinal Inner Fixation System

Common/Usual Name: Pedicle screw spinal system

Classification Names: 21 CFR 888.3070 Pedicle screw spinal system, 21 CFR 888.3050 Spinal interlaminal fixation orthosis Regulation Class: ll

Product Code: MNH, KWP, MNI

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PREDICATE DEVICE III.

Primary predicate: General Spinal System K122994;

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

> INDICATIONS FOR USE

Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

The Spinal inner fixation system employs the same technology as its predicate device K122994. Both have the same indication for use and are made of same raw materials; the bench tests were conducted to verify that the proposed device met all design specifications as was substantially equivalent to the predicate device.

Specification	Predicate Device	Proposed Device
	General Spinal System K122994	Spinal inner fixation system

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Manufacturer	Weigao Orthopaedic Device Co.,Ltd.	Changzhou DingjianMedical ApplianceCo., Ltd.
Class	II
Product Code	MNH, KWP, MNI
Regulation Number	21 CFR 888.3070, 21 CFR 888.3050
Intended Use	Intended for posterior, non-cervical, pedicle fixation for thefollowing indications: severe spondylolisthesis (grade 3 or 4) ofthe L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinalstenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis);tumor; pseudoarthrosis; and failed previous fusion. The deviceis to be used in skeletally mature patients, and for stabilizationand immobilization of the spine as an adjunct to fusion withbone graft. The levels of fixation are T8 - S1.
Indications for Use	The levels of fixation are T8 – S1
Patient Population	The device is to be used in skeletally mature patients
Prescription/OTC Use	Prescription use
Staticcompressionbending: yield load	Similar, the testing results show no statistically significantdifference between two samples groups
Staticcompressionbending: stiffness	Similar, the testing results show no statistically significantdifference between two samples groups
Dynamiccompressionbending	Similar, the testing results show no statistically significantdifference between two samples groups
Statictorsion:torque	Similar, the testing results show no statistically significantdifference between two samples groups
Static torsion: torsionalstiffness	Similar, the testing results show no statistically significantdifference between two samples groups
Materials	Titanium alloy (TiAl4V ELI) whichconforms to ASTM F136	Titanium alloy(TiAl4V ELI) whichconforms to ASTMF16
Biocompatibility	Titanium alloy (TiAl4V ELI) whichconforms to ASTM F136	Titanium alloy(TiAl4V ELI) whichconforms to ASTM F136
Sterility	Provided as non-sterile, needsautoclave prior to use	Provided as non-sterile, needs steamsterilization prior touse

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The following technological differences exist between the subject and predicate device:

. Size of components should be chosen based on patient's body size. The size difference between the proposed device and its predicate does not affect their clinical performance.
. The testing results of the static compression bending test, dynamic compression bending test and static torsion test are similar ,however no statistically significant difference between two samples groups

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Mechanical testing

According to the ASTM F1717, the following tests were carried out:

Static compression bending test
Dynamic compression bending test
Static torsion test

Dissociation testing of screw head

Biocompatibility testing:

The Spinal inner fixation system has permanent contact (>30 days) with bone and tissue.

The Spinal inner fixation system is made of Ti-6Al-4V. According to the ASTM F136, the

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materials have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981.

There is no Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in this Orthopedic Device.

Animal and clinical study

The subject of this premarket submission, Spinal inner fixation system, does not require clinical studies to support substantial equivalence.

VIII. CONCLUSIONS

The non-clinical data supports the substantial equivalence of the device and the performance testing report demonstrates that the Spinal inner fixation system should perform as intended in the specified use conditions. Changzhou Dingjian Medical Appliance Co., Ltd., Inc considers the Spinal inner fixation system does not raise any new issues of safety or effectiveness.

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.