The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

Device Description

PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used solo
· Self-tapping flute centers screw for easy insertion
· Various choice of Screw Length(30,35,40,45,50,55,60,65,70 mm of Length)

AI/ML Overview

This document is a 510(k) summary for the PathLoc-SI Joint Fusion System. It describes a medical device, its intended use, and compares it to already marketed devices to establish substantial equivalence, which is a regulatory requirement for medical devices in the US.

Based on the provided information, I can answer your questions as follows:

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

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of design, material, and indications for use, and through performance testing to established ASTM standards. The "reported device performance" is essentially that the device meets these ASTM standards as part of its substantial equivalence claim.

However, the closest we can get to this information from the provided text is by listing the performance tests conducted and the implicit "acceptance criteria" that the device must pass these tests according to the relevant ASTM standards.

Acceptance Criteria Category	Specific Test (Standard)	Reported Device Performance
Mechanical Performance	Torsional test (ASTM F543-13)	Passed (implicit, as concluded to be substantially equivalent)
	Axial pullout test (ASTM F543-13)	Passed *
	Driving torque test (ASTM F543-13)	Passed *
	Static bending strength (ASTM F2193-14)	Passed *
	Fatigue bending strength (ASTM F2193-14)	Passed *

Note: The document states "Performance Testing was done" (section 8) and concludes that the device is "substantially equivalent" (section 9). This strongly implies the device met the requirements of these standards, though specific numerical results or pass/fail thresholds are not detailed in this summary.

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

This document describes a premarket notification (510(k)) for a medical device. For devices seeking 510(k) clearance, clinical studies with human subjects are often not required if substantial equivalence can be demonstrated through other means, such as mechanical testing and comparison to predicates.

Therefore, no human clinical test set or data provenance is mentioned or appears to have been used in this submission. The "test set" here refers to the physical device components subjected to mechanical testing. The sample size for these mechanical tests (e.g., number of screws tested for torque or bending) is not specified in this 510(k) summary. These tests are typically conducted in a laboratory setting, not with patient data.

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)

Given that this submission relies on mechanical performance testing against ASTM standards and comparison to predicate devices, there was no "ground truth" to be established by clinical experts in the sense of diagnosing patient conditions or interpreting medical images. The "ground truth" for the mechanical tests would be the established specifications and methodologies of the ASTM standards themselves, interpreted by engineers or testing specialists.

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

No adjudication method for human interpretation was used as there was no human clinical test set in this 510(k) submission.

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

No MRMC study was performed. This device is a physical implant (sacroiliac joint fusion system), not a diagnostic imaging or AI-based software device that would involve human readers or AI assistance.

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

No standalone algorithm performance study was done. This device is a physical implant and does not involve an algorithm.

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

As discussed, this submission relies on mechanical and material testing standards (ASTM F543-13, ASTM F2193-14) and comparison to the design and indications for use of legally marketed predicate devices. The "ground truth" for the mechanical tests is the adherence to the published specifications and performance requirements within those ASTM standards.

8. The sample size for the training set

No training set was used as this is a physical medical device, not an AI or machine learning model.

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

Not applicable, as there was no training set.

Summary

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

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

November 14, 2016

L&K Biomed Co., Ltd. Yerim An RA Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, 446-916 Korea

Re: K153656

Trade/Device Name: PathLoc-SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: October 12, 2016 Received: October 13, 2016

Dear Yerim An:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

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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Indications for Use

510(k) Number (if known) K153656

Device Name PathLoc-SI Joint Fusion System

Indications for Use (Describe)

The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

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

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1. Submitter: L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 446-916, Korea Phone. 82-2-6717-1985 e-mail: yerim2706@gmail.com Contact Person: Yerim An
  Date prepared: Nov. 11, 2016

Device Identification 2.

Trade Name	PathLoc-SI Joint Fusion System
Common Name	Sacroiliac Joint Fixation / Sacroiliac Joint Fusion
Product Code	OUR
Regulatory Class	II
Classification Name	21CFR888.3040 Smooth or threaded metallic bonefixation fastener

Purpose of 510(k) 3.

The L&K BIOMED Co.Ltd, here by submits this traditional 510(k): to register our new product PathLoc-Si Joint Fusion System

Predicate or legally marketed devices which are substantially equivalent 4.

Predicate: K112240 Dyna Locking Cannulated Screw .
Additional Predicate: K021932 Synthes 6.5mm Cannulated Screw .
. Additional Predicate: K123702 SILEX SACROILIAC JOINT FUSION SYSTEM
Additional Predicate: K141246 LIFE SPINE SACROILIAC JOINT . FIXATION SYSTEM

Description of the Device 5.

· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used solo
· Self-tapping flute centers screw for easy insertion
· Various choice of Screw Length(30,35,40,45,50,55,60,65,70 mm of Length)

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Materials:

Product	Material	Standard
Arch Screw	Ti-6AI-4V ELI	ASTM F136
Locking Screw	Ti-6AI-4V ELI	ASTM F136
Washer	Ti-6AI-4V ELI	ASTM F136

Indication for Use 6.

The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

Comparison of the technological characteristics of the subject and 7. predicate devices

The PathLoc-SI Joint Fusion System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use.

	Subject Device	Primary predicatedevice	Additional predicatedevice
Item	PathLoc-SI JointFusion System	Synthes 6.5mmCannulated Screw	Dyna LockingCannulated Screwm
Manufacturer	L&K BIOMED Co.,Ltd.	Synthes	U & I Corporation
Material	Ti-6Al-4V ELI	Stainless steel andtitanium alloy	Ti-6Al-4V ELI
510(K) No	K153656	K021932	K112240
Product Code	OUR	HWC, OUR	HWC
RegulationNo.	21CFR888.3040	21CFR888.3040	21CFR888.3040
Class	Class II	Class II	Class II
Intended Use	The PathLoc-SI JointFusion System isintended for sacroiliacjoint fusion forconditions includingsacroiliac jointdisruptions anddegenerativesacroiliitis.	Synthes 6.5mmCannulated Screw isintended for fracturefixation of largebones and largebone fragments,such as femoralneck fractures;slipped capitalfemoral epiphyses;an adjunct to DHS inbasilar neckfractures; tibialplateau fractures;ankle arthrodesis;pediatric femoral	Intracapsularfractures of thefemoral neckIntertrochantericfractures of thefemurTibial plateaufracturesFractures of thedorsal pelvic ringPelvic sacroiliac jointdisruptionAnkle arthrodesisOther indicationswhere cancellousscrews are currently

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neck fractures;intercondylar femurfractures; SI jointdisruptions; andsubtalar arthrodeses.	used and a guidedsystem may bebeneficial

Performance Testing 8.

ASTM F543-13 Standard

Torsional test .
Axial pullout test .
Driving torque test(Insertion/Removal) i

ASTM F2193-14 Standard

Static and fatigue bending strength of metallic spinal screw -

Conclusion 9.

The PathLoc-SI Joint Fusion System is substantially equivalent to legally marketed predicates.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.