Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.

Device Description

Initial LiSi Press is a press-heated ceramic ingot formed through melting the raw materials at a very high temperature. The melting process eliminates all volatile substances and the final product is a complex oxide ceramic available in various shades and translucencies. All of the components of the applicant device have already been used in the predicate devices. The restorations may be further characterized through layering, glazing and staining, and are then cemented in place as the final restoration. The device is packaged in 5 ingots per tube and is available in a range of shades, including high, medium and low translucency, as well as high and medium opacity.

AI/ML Overview

The provided text is a 510(k) premarket notification from the FDA, pertaining to a dental device named "Initial LiSi Press" (a porcelain powder for clinical use). The document primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a study proving a device meets specific acceptance criteria related to an AI/ML algorithm's performance.

Therefore, the document does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/ML device.

The document states:

"No clinical testing has been performed on this device."
The performance testing was "Non Clinical Performance Testing" (biocompatibility assessment and bench performance testing).

It discusses the device's physical and chemical properties and how it compares to predicate devices, but there is no mention of an AI/ML component, human readers, ground truth establishment, or any of the AI/ML-specific criteria you've listed.

To answer your question, information from a document describing the development and validation of an AI/ML-powered medical device would be needed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with a stylized wing-like shape extending above them.

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

June 30, 2016

GC America Inc. Mark Heiss, D.D.S. Director, Academic & Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803

Re: K153136

Trade/Device Name: Initial LiSi Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 27, 2016 Received: June 1, 2016

Dear Dr. Heiss:

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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Page 2 - Mark Heiss, D.D.S

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,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is complex and illegible. There is also a small "-s" near the name.

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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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K153136

Device Name: Initial LiSi Press

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the text "'GC'" in a stylized, sans-serif font. The text is a teal color. The quotation marks are placed before and after the letters "GC".

GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 371-5103

1. Submitter

GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 926-9100
Alternate Contact:	Lori Rietman
Phone:	(708) 926-3092

Date Prepared: May 27, 2016

2. Device Name

Proprietary Name:	Initial LiSi Press
Classification Name:	Powder, Porcelain
Device Classification:	Class II, 872.6660
Product Code:	EIH

3. Predicate Device

Company	Device	510(k) No.	Code No.	Predicate
IVOCLAR VIVADENT, INC	IPS E.MAX PRESS /IPS E.MAX PRESS MULTI	K120134	EIH	Primary
IVOCLAR VIVADENT, INC	IPS E.MAX CAD /IPS E.MAX ZIRCAD	K051705	EIH	Reference

4. Description of Device

The restorations may be further characterized through layering, glazing and staining, and are then cemented in place as the final restoration.

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The device is packaged in 5 ingots per tube and is available in a range of shades, including high, medium and low translucency, as well as high and medium opacity.

HT (High Translucency): HT-BLE, HT-E57, HT-E57, HT-E59, HT-E59, HT-NTL, HT-AMB, HT-B00, HT-B0, HT-A0, HT-A1, HT-A2, HT-A3, HT-A3.5, HT-A4, HT-B1, HT-B2, HT-B3, HT-B4, HT-C1, HT-C2, HT-C3, HT-C4, HT-D2, HT-D3, HT-D4 (27)
MT (Medium Translucency): MT-B00, MT-A0, MT-A1, MT-A2, MT-A3, MT-A3, MT-A4, MT-B1, MT-B2, MT-B3, MT-B4, MT-C1, MT-C2, MT-C3, MT-C4, MT-D2, MT-D3, MT-D4, MT-0, MT-A, MT-B, MT-C, MT-D (24)
LT (Low Translucency): LT-B00, LT-A0, LT-A1, LT-A2, LT-A3, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-B4, LT-C1, LT-C2, LT-C3, LT-C4, LT-D2, LT-D3, LT-D4, LT-0, LT-A, LT-B, LT-C, LT-D (24)

MO (Medium Opacity): MO-0, MO-1, MO-2, MO-3, MO-4 (5) HO (High Opacity): HO-0, HO-1, HO-2, HO-3, HO-4 (5)

న్. Indications for Use
Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3unit bridge up to the second premolar placed on top of an implant abutment.
1. Non Clinical Performance Testing
  A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Bench performance testing was conducted in accordance with ISO 6872:2008 (Dentistry - Ceramic materials) and is suitable for its intended use.

1. Clinical Performance Testing
  No clinical testing has been performed on this device.

8. Technological characteristics

The applicant device is a silica and lithium based glass ceramics that includes silicon dioxide (SiO2), lithium oxide (Li2O), other oxides, and coloring oxides. The glass ceramic applicant device is formed into an ingot which is used in heat-pressed technology to fabricate all ceramic dental restorations. The percentage of chemical components varies to vield a range of shades and transmission of light from high translucent to opaque to optimize esthetics when restorations are placed near natural teeth or other previously restored teeth.

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	Applicant device	Primary Predicate	Reference Predicate
Product category	Initial LiSi Press	IPS e.max Press	IPS e.max CAD
Trade name	Press-heated ceramic ingot	Press-heated ceramic ingot	CAD/CAM ceramic block
Manufacturer	GC CORPORATION	IVOCLAR VIVADENT, INC	IVOCLAR VIVADENT, INC
Indications for use	Fabrication of occlusal veneers, thin veneers,veneers, inlays, onlays, crowns in theanterior and posterior region, 3-unit bridgesin the anterior region, 3-unit bridges in thepremolar region up to the second premolaras the terminal unit, crown or splinted crownon top of an implant abutment and 3-unitbridge up to the second premolar placed ontop of an implant abutment.	For the creation of occlusal veneers, thinveneers, veneers, inlays, onlays, crowns inthe anterior and posterior region, 3-unitbridges in the anterior region, 3-unit bridgesin the premolar region up to the secondpremolar as the terminal abutment andcrown, splinted crown or 3 unit bridge up tothe second premolar placed on top of animplant abutment.	IPS e.max CAD is a CAD/CAM machinable glassceramic based on lithium disilicate for thepreparation of full ceramic crowns, inlays, onlaysand full ceramic 3-unit anterior bridges.IPS e.max ZirCAD consists of machinablezirconia blocks for the preparation of full ceramiccrowns, onlays and 3- and 4- unit bridges andinlay bridges (anterior and molar.)
Product description	Initial LiSi Press is a heat-pressed ceramicingot for full ceramic restorations of bothanterior and posterior.	IPS e.max Press is lithium disilicate glass-ceramic ingots for the Press technology.	IPS e.max CAD is a lithium disilicate glass-ceramic blocks for the CAD/CAM technology.IPS e.max ZirCAD is a yttrium-stabilizedzirconium oxide block.

Table 5.1 Comparison of applicant device to primary and reference predicate

Page 5.3 of 5.4

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9. Substantial equivalence

The applicant device and primary predicate device both are silica lithium based ceramics with formulations of ceramic oxides used in combination to create a range of shades and translucencies; and that the form of the device is an ingot that is used in heat-pressed technology to fabricate all ceramic restorations. The difference is that the chemical formulation is not identical; however bench testing for both devices was conducted in accordance with ISO 6872:2008 (Dentistry - Ceramic Materials) confirming that the physical properties of the applicant device are comparable to the primary predicate for the same intended use.

The applicant device is similar to the reference device in that both are also silica lithium based ceramics and includes other glass and ceramic oxides in the device formulation. While the technology used to fabricate the all ceramic restoration differs in that the applicant device uses heatpressed technology and the reference device uses CAD/CAM technology; the differences in chemical composition and technology used to fabricate the all ceramic restorations do not alter the raise concerns about the intended use of the applicant device.

Wording of indications for use statement of the applicant device for fabrication of crown or splinted crown on top of an implant abutment has the same intended meaning as the words for creation of crown, and splinted crown. The indications for use are equivalent for Initial LiSi Press and the primary predicate device.

10. Conclusion

Based on device formulation and non clinical performance testing, including bench testing and biocompatibility assessment, Initial LiSi Press is substantially equivalent to the predicate devices.

Page 5.4 of 5.4

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.