Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: degenerative disc disease (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; pseudarthrosis; and/or 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.

Device Description

The Spinal Inner Fixation System is a medical device system for surgical fixation of the spine. It is made up of pedicle screws, set screw, rods and cross connecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implants are single-use. The surgical instruments may be reprocessed and re-used. The Spinal Inner Fixation System includes model GB1Z-I and GB1Z-II according to the rod diameter, and each model comprises of different length rods, various length and diameter screws, set screws and accessories. Both models are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option. Surgical instruments are provided with the device system.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K222031 does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of AI/algorithm performance.

The document discusses a "Spinal Inner Fixation System," which is a medical device for surgical fixation of the spine, made up of mechanical components like pedicle screws, rods, and connectors.
The "Performance - Bench" section mentions bench performance testing completed according to ASTM F1717-18 standards, including static compression bending, dynamic compression bending, and static torsion. This information pertains to the mechanical properties of the physical device, not the performance of an AI or algorithmic medical device.

Therefore, I cannot provide details on:

A table of acceptance criteria and reported device performance for an AI/algorithm.
Sample sizes for test sets or data provenance for an AI/algorithm.
Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
Adjudication methods for an AI/algorithm test set.
MRMC comparative effectiveness studies or effect sizes for human readers with and without AI assistance.
Standalone performance of an AI algorithm.
Type of ground truth used for an AI algorithm.
Sample size for a training set for an AI algorithm.
How ground truth for a training set was established for an AI algorithm.

The K222031 document is a 510(k) summary for a mechanical orthopedic implant, not an AI-powered medical device.

Summary

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October 28, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Changzhou Geasure Medical Apparatus and Instruments Co., Ltd % Ms. Xiaoqing Xue Registration Engineer Sinow Medical AS Vestre Fantoftasen 44, 5072, Bergen, Norway

Re: K222031

Trade/Device Name: Spinal Inner Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: October 6, 2022 Received: October 7, 2022

Dear Ms. Xue:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222031

Device Name Spinal Inner 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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510(K) Summary

K222031

Preparation Date:	Oct. 06, 2022
Submitter	Changzhou Geasure Medical Apparatus and Instruments Co., LtdNo. 12, Jinfeng Road, West Taihu Science and TechnologyIndustrial Park, Changzhou, Jiangsu, P.R. ChinaJing Huang, Management RepresentativeEmail: huangjing@geasure.comPhone:+86 13656146897
DesignatedSubmissionCorrespondent	Company: Sinow Medical AS
	Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway
	Contact Person: Xiaoqing Xue
	Telephone: +86 15161196032Email: xue@bergemed.com
Subject Device	Trade name	Spinal Inner Fixation System
	Common name	Pedicle Screw Spinal System
	Regulatory Class	II
	RegulationNumber	21 CFR 888.3070
	Product Codes	NKB
	ClassificationPanel	Orthopedic
	ClassificationName	Thoracolumbosacral Pedicle Screw system
	Manufacturer	Changzhou Dingjian Medical ApplianceCo., Ltd.
	Trade name	Spinal Inner Fixation System
	510(K) Number	K143013
	Regulatory Class	II
Primary PredicateDevice	RegulationNumber	21 CFR 888.3070,888.3050
	Product Codes	MNH, MNI, KWP
	ClassificationPanel	Orthopedic
	ClassificationName	Thoracolumbosacral Pedicle ScrewSystem, Spinal Interlaminal FixationOrthosis
	Intended Use /Indications for Use	Spinal Inner Fixation System is intended for posterior,non-cervical, pedicle fixation for the following indications:degenerative disc disease (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; pseudarthrosis; and/or 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.
Device Description	The Spinal Inner Fixation System is a medical device system for
	surgical fixation of the spine. It is made up of pedicle screws, set
	screw, rods and cross connecting devices. The implanted parts
	confer stabilization and fusion of two or more spinal segments
	and are to be removed once their stabilizing function is no longer
	required. The implants are single-use. The surgical instruments
	may be reprocessed and re-used.
	The Spinal Inner Fixation System includes model GB1Z-I and
	GB1Z-II according to the rod diameter, and each model
	comprises of different length rods, various length and diameter
	screws, set screws and accessories.
	Both models are designed for internal posterior thoracolumbar
	fixation of the spine. Patient diagnosis and individual conditions
	should be taken into consideration when selecting the surgical
	option.
	Surgical instruments are provided with the device system.
Materials	Titanium alloy (Ti-6Al-4V) ELI
	The devices are colored using an anodizing manufacturing
Coatings/Colorants	process. No coatings or colorants are added to the device with
	this process.
SterilizationMethod	The devices are provided non-sterile; validated manual cleaning
	and steam sterilization instructions are provided for the end user
	before implantation.
Performance -Bench	The ASTM F1717-18 standards were utilized to complete thefollowing bench performance testing on the subject and predicate
	device:
	• static compression bending
	• dynamic compression bending,
	• static torsion
	The Spinal Inner Fixation System is substantially equivalent to
	the predicate device when evaluating intended use and
SubstantialEquivalence	technological characteristics.
	• The subject device has the identical intended use as the
	predicate device.
	The subject device and predicate devices are substantiallyequivalent with only minor differences regarding:Mechanism of action Rods Set screw Cross connector Bench performance: static compression, dynamiccompression and static torsion These differences do not raise new questions of safety andeffectiveness.
Conclusion	Non-clinical data demonstrates the Spinal Inner Fixation Systemdevice is substantially equivalent to the predicate device.

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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.