The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Sterile NS System." This notification seeks to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes the comparison to predicate devices rather than a standalone study with defined acceptance criteria and performance metrics for the novel device itself.

Based on the provided text, the following information can be extracted and interpreted regarding the "acceptance criteria" and "study."

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the traditional sense, such as specific thresholds for sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical tests to verify compliance with design specifications and standards.

Acceptance Criteria (Implied by Substantial Equivalence and Non-Clinical Testing)	Reported Device Performance (from "Non-Clinical Test Summary")
Functional Equivalence: Same intended use as predicate devices.	"The Sterile NS System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures." (Same as predicate)
Material Equivalence: Same materials as predicate devices.	Plate: Pure titanium Grade4 (ASTM F67); Screw: Titanium alloy (Ti-6AL-4V ELI, ASTM F136) (Same as predicate)
Design Feature Equivalence: Same design features (thickness, dimensions, surface) as predicate devices.	Plate: Plate thickness 0.3mm ~ 1.0mm, Surface: Anodized; Screw: Screw Outer Dia. 1.4 ~ 1.8mm, Screw Length 2.2~5.0mm, Surface: N/A (Same as predicate). Compliance ensured by "Dimension test" for both plate and screws.
Biocompatibility: Conform to relevant standards.	"Conform" (Same as predicate)
Sterilization Efficacy & Safety: New sterilization method (radiation-sterile) does not raise new safety or performance issues compared to predicate's non-sterile (steam sterilization by user).	"The performance test data provided in this submission proves that this differences do not raise new issues in safety and performance." (Specific results of these "performance tests" for sterilization are not detailed in this summary, but are implied to be part of the submission.)
Compliance with Standards & Worst Case Criteria: Device meets all design specifications and applicable standards.	"The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." (Specific standards and precise results are not detailed but are stated as met. Implied tests: Dimension test for plate and screws.)

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

The document states: "No clinical studies were considered necessary and performed." Therefore, there is no test set in the sense of patient data. The "test set" refers to the physical devices that underwent non-clinical testing. The sample size for these non-clinical tests (e.g., how many plates or screws were dimensionally tested) is not specified in the provided text. The data provenance is also not specified beyond the manufacturer being in Korea.

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)

Not applicable. This device is a physical medical implant, not an AI/diagnostic software, and no human ground truth establishment (e.g., by clinicians or radiologists) is described or relevant for the substantial equivalence claim.

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

Not applicable. As this is not a diagnostic device involving human interpretation, adjudication methods are not relevant.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm or AI device.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and established standards (e.g., ASTM F67, ASTM F136). The tests (e.g., "Dimension test") verify that the manufactured devices conform to these pre-defined specifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

September 11, 2017

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

Jeil Medical Corporation Ji Won Song RA Specialist 55 Digital-ro. 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul, 152-728 KR

Re: K170368

Trade/Device Name: Sterile NS System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: August 9, 2017 Received: August 10, 2017

Dear Ji Won Song:

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 (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.

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170368

Device Name Sterile NS System

Indications for Use (Describe)

The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.

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)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3536.

510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared [21 CRF 807.92(a)(a)]

20. January 2017

2. Submitter's Information [21 CFR 807.92(a)(1)]

• Name of Sponsor:	Jeil Medical Corporation
- Address:	702-703-704-705-706-804-805-807-812-ho,55 Digital-ro34-gilGuro-gu, Seoul, 152-728, Korea

Contact Name: Ji won Song / RA Specialist
- Telephone No. : +82 2 850 3587 -
- Fax No. : +82 2 850 3536 -
- -Email Address : sjw@jeilmed.co.kr

Registration Number:	3004049923
Name of Manufacturer:	Same as Sponsor
Address:	Same as Sponsor

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

●	Trade Name:	Sterile NS System
●	Common Name:	Bone plate & screw
●	ClassificationName:	Preformed alterable cranioplasty plateappliances and accessories
●	ClassificationPanel:	Neurology
●	ClassificationRegulation:	21 CFR 882.5320, 21 CFR 882.5250, 21 CFR 882.5360
●	Product Code:	GWO, GXR, HBW
●	Device Class:	II

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

• 510(k) Number:	K112812, K141452
• Applicant:	Jeil Medical Corporation
• Common Name:	Bone plate & screw
• Device Name:	Leforte Neuro System Bone plate and

Device Name: Leforte Neuro System Bone plate and screw

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Image /page/4/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3536.

Bone plate & screw

There are no significant differences between the subject devices and the predicate devices (K112812, K141452) that would adversely affect the use of the product.

Description of the Device [21 CFR 807.92(a)(4)] 5.

The Sterile NS System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

Intended Use [21 CFR 807.92(a)(5)] 6.

The Sterile NS System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Sterile NS System, Neurology: With same thickness, titanium grade, dimensions. However, the subject device changed sterile method under the predicate devices (K112812, K141452).

Non-Clinical Test Summary:

The test was conducted to verify that the subject device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and worst case criteria report:

. Plate
Dimension test -
. Screws
- Dimension test -

The subject device has the same device characteristics as the predicate (unmodified) device.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same anodization, shape and dimensions. The differences are sterilization method; however; the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.

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	Predicate (Unmodified) device	Subject device
510k Number	K112812, K141452	-
Manufacturer	Jeil Medical Corporation	Jeil Medical Corporation
Product Code	GWO, GXR, HBW	GWO, GXR, HBW
Intended use	The Leforte Neuro System BonePlate and Screw is intended for usein selective trauma of the cranialskeleton, cranial surgery andreconstructiveprocedures.	The Sterile NS System is intendedfor use in selective trauma of thecranial skeleton, cranial surgery andreconstructiveprocedures.
Material	Plate- Pure titanium Grade4(ASTM F67)Screw- Titanium alloy(Ti-6AL-4V ELI, ASTM F136)	Plate- Pure titanium Grade4(ASTM F67)Screw- Titanium alloy(Ti-6AL-4V ELI, ASTM F136)
Design features	Plate- Plate thickness 0.3mm ~ 1.0mm- Surface: AnodizedScrew- Screw Outer Dia. 1.4 ~ 1.8mm- Screw Length 2.2~5.0mm- Surface: N/A	Plate- Plate thickness 0.3mm ~ 1.0mm- Surface: AnodizedScrew- Screw Outer Dia. 1.4 ~ 1.8mm- Screw Length 2.2~5.0mm- Surface: N/A
Sterilization	Non-Sterile(Steam sterilization by user)	Sterile(Radiation-sterile)
Usage	Single use	Single use
Packaging	Polyethylene Zip Lock PouchCardboard Box	PET, Tyvek,Cardboard Box
Biocompatibility	Conform	Conform

Conclusion [21 CFR 807.92(b)(3)] 9.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that Sterile NS System is as safe and effective and substantially equivalent to the predicate device as described herein.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).