BEAUTIFIL II Gingiva by SHOFU DENTAL CORPORATION

The provided document is an FDA 510(k) clearance letter for a dental device (Beautifil II Gingiva) and its Indications for Use. It does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with specific acceptance criteria in the manner often seen for novel AI/medical imaging devices.

Therefore, many of your requested points cannot be answered from this document.

However, I can extract the following based on the nature of the document:

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

Not available in this document. This document is a clearance letter, not a performance study report. For a dental restorative material like this, acceptance criteria would typically involve physical, chemical, and biological properties (e.g., flexural strength, wear resistance, biocompatibility, color stability) established through ISO standards or similar benchmarks. The document doesn't detail these or the device's specific performance against them.

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

Not available in this document. This document does not describe a test set or data provenance from a device performance study.

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/available in this document. This document does not pertain to an AI device or a study requiring expert ground truth establishment for a test set.

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

Not applicable/available in this document.

5. If a multi-reader multicase (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/available in this document. This is a dental restorative material, not an AI-powered diagnostic device.

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

Not applicable/available in this document.

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

Not applicable/available in this document. For dental materials, the "ground truth" for demonstrating substantial equivalence often relies on adherence to material standards and potentially in-vitro or ex-vivo testing, rather than clinical ground truth as defined for diagnostic devices.

8. The sample size for the training set

Not applicable/available in this document. This document does not describe a training set as it's not an AI device.

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

Not applicable/available in this document.

Summary of what the document DOES provide:

Device Name: BEAUTIFIL II Gingiva
Regulatory Status: 510(k) cleared, Class II (Special Controls)
Regulation Number/Name: 21 CFR 872.3690 / Tooth Shade Resin Material
Product Code: EBF
Indications for Use:
- Class V restorations (Cervical caries, root caries, wedge-shaped defects)
- Covering of exposed or discolored necks of teeth
- Restoration of esthetic appearance of gingival areas
Type of Use: Prescription Use
Predicate Device Information: While not explicitly named in this letter, the 510(k) process is based on demonstrating substantial equivalence to a legally marketed predicate device. The actual submission (K151700) to the FDA would contain details about the predicate.

To obtain the detailed performance data, acceptance criteria, and specific study reports, one would typically need to refer to the full 510(k) submission (K151700) available through the FDA's public database, or directly from the manufacturer if they publish such data. The clearance letter itself is a regulatory outcome, not a detailed technical report.

Summary

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

March 2, 2016

Shofu Dental Corporation Mr. Mauro Malzyner Regulatory Affairs and Official Correspondent 1225 Stone Drive San Marcos, California 92078

Re: K151700

Trade/Device Name: Beautifil II Gingiva Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 25, 2016 Received: January 27, 2016

Dear Mr. Malzyner:

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.

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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 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,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151700

Device Name

BEAUTIFIL II Gingiva

Indications for Use (Describe)

· Class V restorations (Cervical caries, root caries, wedge-shaped defects)
Covering of exposed or discolored necks of teeth
Restoration of esthetic appearance of gingival areas

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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Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.