The Speedy Flap is designed for the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures. This device is made of the Titanium Alloy (ASTM F136). The Speedy Flap is composed of three parts: upper plate, lower plate and rod. This device supplied sterile and single use only.

AI/ML Overview

The provided text describes the "Speedy Flap System", a medical device for cranioplasty plate and cranial fracture fixation, and its comparison to predicate devices, CranioFix and CranioFix 2 Titanium Clamp Systems, for 510(k) clearance. This means the studies conducted are primarily non-clinical, mechanical, and material tests to demonstrate substantial equivalence, rather than clinical studies on human performance or AI effectiveness. Therefore, many of the requested points related to AI, human readers, and ground truth in a clinical context are not applicable.

Here's the information extracted and organized based on your request, with "N/A" for inapplicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Speedy Flap System)
Dimension Test	Within ±5% error range	Within ±5%
Movement Force Test	Performance comparable to or better than predicate device (CranioFix 2)	SF-12F: 141N; SF-20F: 98N (Predicate: 11mm: 94N, 20mm: 96N) - Higher, thus better
Separation Force Test	Performance comparable to or better than predicate device (CranioFix 2)	SF-12F: 323N; SF-20F: 198N (Predicate: 11mm: 312N, 20mm: 147N) - Higher, thus better
Separation Force testing before and after rod cutting	No significant change in separation force after rod cutting	No significant change; supports upper disk will not loosen
Climatic conditioning, Package performance, Visual inspections, Gross leak detection (bubble) and seal strength (peel) testing	No anomalies; suitability of package configuration for distribution environment	No anomalies; suitable package configuration confirmed
Chemical Analysis (Qualitative analysis of organic residual)	No other elements on the surface other than raw material elements; no residual detected	No other elements on surface besides titanium alloy; no residual detected
Shelf Life Test (Accelerated and real-time)	Product meets all acceptance criteria after aging (3-year shelf life)	Product met all acceptance criteria
Sterilization Validation Test	Sterilization method validated as effective	Sterilization method validated as effective through study

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

The document does not specify a distinct "test set" in the context of clinical data. The tests performed are non-clinical, mechanical, and material tests. The sample sizes for these tests (e.g., number of devices tested for movement force, separation force) are not explicitly stated in the summary, nor is the provenance of "data" in terms of country of origin or retrospective/prospective. The data is generated from laboratory testing of the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. As this is a non-clinical device clearance, there is no "ground truth" established by medical experts in the context of diagnostic or treatment performance on human cases. The ground truth for mechanical/material tests is derived from engineering standards and measurements.

4. Adjudication method for the test set

N/A. There is no "adjudication method" described as the tests are for physical properties against defined standards, not for interpretation of medical images or patient outcomes.

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

N/A. This device is a physical medical implant, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study and AI-related effectiveness are not relevant.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests is based on:

Engineering specifications and measurements: For dimension, movement force, and separation force.
Established standards: Such as ASTM D4332-13, ASTM F136-11, ISO 11137-1, etc., for package integrity, material composition, and sterilization validation.
Visual inspection and chemical analysis results: For material integrity and cleanliness.

8. The sample size for the training set

N/A. There is no concept of a "training set" in the context of this device's non-clinical safety and effectiveness testing.

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

N/A. As there is no training set, this question is not applicable.

Summary

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

December 22, 2014

Jeil Medical Corporation % Ms. Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 2651 E Chapman Avenue, Suite 110 Fullerton, CA 92831

Re: K130447

Trade/Device Name: Speedy Flap System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Non-Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, GXR Dated: November 21, 2014 Received: November 24, 2014

Dear Ms. Chung:

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

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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.

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" (21CFR 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,

Carlos L. Pena -S FD/A

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) K130447

Device Name Speedy Flap System

Indications for Use (Describe)

Speedy Flap System is intended for use in the fixation of cranioplasty plates, and fixation of cranial fractures.

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) Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

1. Date

December 17, 2014

2. Applicant

	Company
Name	Jeil Medical Corporation
Address	#702, Kolon science valley 2nd811, Guro-Dong, Guro-GuSeoul, Republic of Korea 152-050
Phone	+82 2 850-3524
Fax	+82 2 850-3525
Contact	Jieun Kim

3. Submission Contact Person

Priscilla Chung LK Consulting Group USA, Inc. US Agent for Jeil Medical Corporation Tel: 714-202-5789 Fax: 714-409-3357 E-mail: juhee.c@lkconsultinggroup.com

4. Device Identification

Proprietary Name Speedy Flap System
· Common Name Cranioplasty Plate Fastener
· Classification Name Plate, Cranioplasty

5. Device Classification

י Classification: Class II
י Product Code: GXN, GXR
Regulation Number: 21CFR882.5330, 21 CFR 882.5250 트

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. Review Panel: Neurology

Predicate Devices 6.

510(k) Number: K040864 and K122353 I
Product Name: CranioFix and CranioFix 2 Titanium Clamp System '
Manufacturer's Name: Aesculap, Inc. I

Device Description 7.

8. Indication for Use

The Speedy Flap is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Substantial Equivalence Discussion 9.

The Speedy Flap System has the same device characteristics, intended use, materials, design and use concept, sterilization, etc. as the predicate device, the CranioFix System. Only the dimensional specifications - shape, diameter and length - are slightly different. There are no technological differences that affect the safety or effectiveness of the device.

The table below compares the Speedy Flap System attributes with those of the predicate device.

Attribute	Speedy Flap System	CranioFix and CranioFix2 Titanium ClampSystem
510(k)	K130447	K040864 K122353
Manufacturer	Jeil Medical Coporation	Aesculap, Inc.
Intended use	The Speedy Flap Systemis intended for use infixation of cranioplastyplates, covering burrholes, and fixation ofcranial fractures.	The CranioFix System isintended for use in fixationof cranioplasty plates,covering burr holes, andfixation of cranialfractures.
Device Design	Clamp Outer DiameterSF-12F - 12mmSF-16F - 16mm	Clamp Outer DiameterFF490T - 11mmFF491T - 16mm

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	SF-20F - 20mm	FF492T - 20mm
	Clamp LengthSF-12F - 42.1mm,SF-16F - 43.3mm,SF-20F - 43.3mm	Clamp LengthFF490T - 51.0mm,FF491T - 51.0mm,FF492T - 51.0mm
	Movement force betweenthe Plate and the Rod:
Technical Specification	SF-12F: 141NSF-20F: 98N	Cranio Fix2(11mm): 94NCranio Fix2(20mm): 96N
	Separation force betweenthe Plate and the Rod:
	SF-12F: 323NSF-20F: 198N	Cranio Fix2(11mm): 312NCranio Fix2(20mm): 147N
Biocompatibility	Acceptable	Acceptable
Compositionof Material	Titanium Alloy Ti6Al4VELIconforming to ASTMF136-11	Titanium Alloy Ti6Al4V ELIconforming to ASTMF136-11
Usage	Not Reusable	Not Reusable
Sterilization	Radiation Sterilization	Radiation Sterilization

The cranial plates and rods of the Speedy Flap System are substantially equivalent to the cranial plates and rods of its predicate Device, CranioFix System. There are no technological differences that affect the safety or effectiveness of the device.

10. Non-clinical testing

Test	Test Method	Results
Dimension Test	Measure the dimension ofthe test sample by Vernia-Calipus. The tolerance ofthe error range of thedimension shall be within±5%.	within ±5%
Movement Force Test	Compress the axial load atthe lower plate at a rate of1mm/min. Measure themaximum load that thelower plate fixes.	Speedy Flap Syste- SF-12F: 141N- SF-20F: 98NCranioFix System:- CranioFix 2 (11mm):94N- CranioFix 2 (20mm):96N
Separation Force Test	Grip the rod of the systemand apply compressiveaxial load at a rate of1mm/min until the rod isseparated from the plate.	Speedy Flap Syste SF-12F: 323N SF-20F: 198N CranioFix System: CranioFix 2 (11mm): 312N CranioFix 2 (20mm): 147N
Separation Forcetesting before andafter rod cutting	Same test method asabove.Compare test resultsbetween the sample withthe rod and the samplewith the rod cut	No significant change. Thetest results support that theupper disk will not beloosened after the rodcutting.
Climatic conditioning,Packageperformance, Visualinspections, Grossleakdetection(bubble) andseal strength(peel)testing	The purpose of testing wasto validate the ability of thepackage systems toprotect the Speedy FlapSystem from hazardstypically associated withthe shipping anddistribution environment.The testing was performedin accordance with thefollowing standards. ASTM D4332-13 ASTM D5276-98 ASTM D642-00 ASTM D999-08 ASTM D4728-06 ASTM D6344-04 ASTM D5276-98 ASTM F1886/F1886M-09 ASTM F2096-11 ASTM F88/F88M-09	There were no anomaliesthroughout the conduct ofthe test and the test resultsof all the test samplessupport the suitability ofthe package configurationfor the Speedy FlapSystem.
Chemical AnalysisQualitative analysis oforganic residual	SEM(ScanningElectron Microscopy)Gas chromatographMass spectrometer	There was no otherelements on the surfaceof the subject deviceother than the elementsof the rawmaterial(titanium alloy). The residual detected.
Shelf Life Test	Accelerated and real timeshelf life testing were	The product met allacceptance criteria
	conducted to establish 3year shelf life of theSpeedy Flap System.Sterility, visual inspection,package integrity and theperformance of the subjectdevice were evaluatedafter aging.
SterilizationValidation Test	Sterilization validation testwas performed to validate	The sterilization method forthe Speedy Flap System
	the sterilization method forthe Speedy Flap System.	has been validated aseffective through the study.
	The testing was conducted
	in accordance with the
	following standards.ISO 11137-1트
	ISO 11137-2■
	ISO 11137-3■

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The test results of the movement force test and the seperation force test of the subject device were higher than the predicate devie; therefore, we conclude that the subject device performs as well as or better than the predicate device. Other testing results support that the subject device has a safety profile that is similar to the predicate devices.

11. Conclusions

Based on the information provided in this premarket notification, Jeil Medical Corporation concludes that Speedy Flap System has a safety and effectiveness profile that is similar to the legally marketed predicate devices.

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).