To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.

Device Description

Oniko nail brace is a device for correcting the shape for painful and/or overcurved nails without the use of any operation or anesthesia. Oniko nail brace is composed of metal hooks and silicone bands. The metal hooks grasp the nail sides open to correct the shape or painful and/or overcurved nails.

AI/ML Overview

This document does not contain the specific information required to answer your request in detail about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary for the "Oniko nail brace," which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, and ground truth establishment.

However, based on the Performance Data section, I can infer a general type of "acceptance criteria" for biocompatibility and mention the clinical results used as evidence.

Here's what I can extract and what is missing from the provided text:

Inferred/Extracted Information:

Section	Description
Acceptance Criteria (Inferred from Performance Data)	Biocompatibility: Non-cytotoxicBiocompatibility: Non-sensitizerBiocompatibility: Non-irritantClinical Effectiveness: Demonstrated by "clinical results" (specific metrics or thresholds are not provided)
Reported Device Performance	The device was found to be non-cytotoxic.The device was found to be non-sensitizer.The device was found to be non-irritant.Supported by "clinical results" (no specific performance metrics given).
Type of Ground Truth Used	For the biocompatibility claims: likely laboratory testing (in vitro/in vivo assays). For clinical effectiveness: "clinical results" likely refer to expert assessment of nail conditions or patient-reported outcomes, but the specific type of ground truth is not detailed.

Missing Information (Not available in the provided text):

A table of acceptance criteria with specific numerical thresholds and the reported device performance against those thresholds. The document only broadly states "non-cytotoxic, non-sensitizer, and non-irritant" and "supported with clinical results" but lacks quantitative criteria or metrics.
Sample size used for the test set and data provenance: No details on the number of patients/nails, country of origin, or whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. The device is a physical brace, not an AI-assisted diagnostic tool, so an MRMC study would be highly unlikely for this product.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
Sample size for the training set: Not applicable and not mentioned.
How the ground truth for the training set was established: Not applicable and not mentioned.

Conclusion based on the provided text:

The 510(k) summary for the "Oniko nail brace" emphasizes substantial equivalence to a predicate device (K960843 - Stop-n-grow). The performance data section briefly mentions that the device demonstrated non-cytotoxicity, non-sensitization, and non-irritation, supported by "clinical results." However, it does not provide detailed acceptance criteria, specific study designs, sample sizes, data provenance, ground truth establishment methods, or expert qualifications necessary to answer most of your detailed questions. The document aims to show that the device is as safe and effective as a legally marketed predicate, rather than providing an in-depth scientific study report.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three heads.

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

April 25, 2018

Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti Fatma Erdogan Official Correspondent Sanatkarlar Cad. No:5 Angora Evleri Beysukent Cayyolu, 06800 TR

Re: K162525

Trade/Device Name: Oniko nail brace Regulatory Class: Unclassified Product Code: MOZ Dated: March 5, 2018 Received: March 5, 2018

Dear Fatma Erdogan:

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 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.

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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.

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162525

Device Name Oniko nail brace

Indications for Use (Describe)

To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant:	Begum Saglik, Tıbbi Malzemeler & Danısmanlık Ltd StiResit Galip cad. No: 124/10 GOP Cankaya 06700 Ankara TurkeyPhone: +90 312 4461919Fax: +90 312 4475444
Contact person:	Fatma Gülru Erdogangulruer@gmail.com
Date Summary Prepared:510(k) Number:	April 17, 2018K162525
Trade Name:Name of device:	Oniko nail braceNail brace
Classification:Product code:Device Contact Class:Advisory Panel:	UnclassifiedMQZPermanent (>30 days)General & Plastic Surgery
Predicate Device:	K960843- Stop-n-grow, European Touch Co., Inc.
Device Description:	Oniko nail brace is a device for correcting the shape for painful and/orovercurved nails without the use of any operation or anesthesia.
Intended Use:	To correct the shape of overcurved and/or painful nails without operation. Toloosen and give shape to thickened nails, overcurved nails and pincer nailswithout operation.
Technological Characteristics:	Oniko nail brace is composed of metal hooks and silicone bands. Themetal hooks grasp the nail sides open to correct the shape or painful and/orovercurved nails.
Performance Data:	Assessment of the Oniko nail brace demonstrated that the device is non-cytotoxicnon-sensitizer, and non-irritant, which are supported with clinical results.
Substantial Equivalence Discussion/Conclusion:	Oniko nail brace is substantially equivalent to the Stop-n-grow (K960843). Oniko nail brace does not raise different questions of safetyand effectiveness compared to the predicate device. The Oniko Nail Brace hassimilar intended use and principles of operation as the predicate device. Theminor differences between Oniko nail brace and Stop-n-grow do not raisedifferent questions of safety and effectiveness.

Regulation Number and Section

N/A