The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.

Device Description

The APVolution System consists of several silica glass ceramic materials used to create allceramic, ceramic-metal or ceramic-zirconia dental restorations. The APVolution System includes three ceramic ingots for use in the fabrication of all-ceramic (APVolution S), press-to-metal (APVolution M) or press-to-zirconia (APVolution Z) restorations. The system also includes powders and pastes for use in build-up and shaping of the final restoration, as well as shades and glazes for use in achieving acceptable aesthetics.

AI/ML Overview

This document is a 510(k) premarket notification for the "APVolution System" and does not contain information about a study proving the device meets acceptance criteria in the manner requested (e.g., sample size, expert ground truth, MRMC study). Instead, it's a declaration of conformity to existing ISO standards.

However, I can extract the acceptance criteria and the type of "performance" or "testing" that was done to demonstrate conformity.

Here's a breakdown of the requested information based on the provided text, focusing on the available details:

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

Acceptance Criteria (Standard & Section)	Reported Device Performance
ISO 6872 Dentistry - Ceramic Materials	The APVolution System components met all requirements of the ISO 6872 standard.
Specific Inspections & Tests in ISO 6872:
- Identification of Types & Classes of System Components	Tested to confirm compliance
- Uniformity	Tested to confirm compliance
- Freedom from Extraneous Materials	Tested to confirm compliance
- Mixing & Condensation Properties (Class I Ceramics)	Tested to confirm compliance
- Physical & Chemical Properties	Tested to confirm compliance
- Flexural Strength	Tested to confirm compliance
- Linear Thermal Expansion Coefficient	Tested to confirm compliance
- Glass Transition Temperature	Tested to confirm compliance
- Chemical Solubility	Tested to confirm compliance
- Radioactivity	Tested to confirm compliance
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry	The APVolution System components met the biocompatibility requirements described in ISO 7405.
Specific Test in ISO 7405:
- ISO 10993-5 cytotoxicity test: L929 cell monolayer proliferation/inhibition during contact with extended (7 day) extraction using DMSO in complete cell culture medium	The APVolution components met all requirements of the ISO 7405 standard (referring to the cytotoxicity test results). Proliferation or inhibition of L929 cell monolayer was evaluated.

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 does not specify sample sizes for the tests conducted under ISO 6872 or ISO 7405. It's common in these types of submissions to refer to the standard itself which defines the testing methods and sample sizes, rather than detailing them in the submission. The data provenance is not mentioned.

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)

This information is not applicable to the type of testing described (physical material properties and biocompatibility). Ground truth in this context is established by the standardized methods and acceptance limits defined in the ISO standards, not by expert interpretation of observational data.

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

Not applicable. The tests are objective measurements of material properties and biological response according to defined standard protocols.

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 device is a dental ceramic system, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

Not applicable. This is a material device, not an algorithm.

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

The "ground truth" for this device's performance is derived from the acceptance criteria and test methods defined within the ISO 6872 (for ceramic materials) and ISO 7405 (for biocompatibility) international standards. These standards provide objective, measurable criteria for attributes like flexural strength, chemical solubility, and cytotoxicity.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a material device being evaluated against predefined standards, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, no ground truth was established in this context.

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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

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

June 5, 2017

Aesthetic-Press, LLC % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K163228

Trade/Device Name: ApVolution System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 25, 2017 Received: May 2, 2017

Dear Pamela Papineau:

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

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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.

Mary S. Runner -A

Tina Kiang, Ph.D. Acting 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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APVolution ᠪြို့နေရွာTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: 19MB498! 8910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163228

Device Name

APVolution System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Appendix A - 510(k) Summary (revised)	K163228
Date:	April 25, 2017
Owner's Name:	Aesthetic-Press, LLC
Address:	6613 State Road 54New Port Richey, FL 34653
Telephone:	415-692-5372
Fax:	415-723-7075
Contact Person:	Pamela Papineau, RAC (US, EU, CAN)Delphi Medical Device Consulting, Inc.5 Whitcomb AvenueAyer, MA 01432
Telephone:	(978) 772-3552
Fax:	(978) 796-5460
Subject Device:
Trade Name:	APVolution System
Common Name:	Dental Ceramic
Product Code:	EIH
FDA Regulation:	21 CFR 872.6660 - Porcelain Powder for Clinical Use
Device Classification:	Class II
Predicate Device:
Product Name:	DCceram System
Common Name:	Dental Ceramic
Product Code:	EIH
FDA Regulation:	21 CFR 872.6660 - Porcelain Powder for Clinical Use
Device Classification:	Class II
Premarket Notification:	K141400
Indications for Use
The APVolution System is used to fabricate prostheses for missing/damaged teeth. The

The APVolution aged teeth licate pro 18/ da pressable ceramic ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.

Device Description:

The APVolution System consists of several silica glass ceramic materials used to create allceramic, ceramic-metal or ceramic-zirconia dental restorations. The APVolution System includes

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three ceramic ingots for use in the fabrication of all-ceramic (APVolution S), press-to-metal (APVolution M) or press-to-zirconia (APVolution Z) restorations. The system also includes powders and pastes for use in build-up and shaping of the final restoration, as well as shades and glazes for use in achieving acceptable aesthetics. The APVolution System components are listed below in the Substantial Equivalence summary table.

Substantial Equivalence

The Aesthetic-Press APVolution System is substantially equivalent to the Ceramay DCceram System (K141400). Substantial equivalence, which is summarized below, is based on indications for use and device physical and technological characteristics.

	Aesthetic-Press APVolution System(current submission)	Ceramay DCceram System(K141400)
Device Common/Usual Name	Dental Ceramic	Dental Ceramic
Device Class	Class II	Class II
Product Code / Regulation	EIH / 21 CFR 872.6660	EIH / 21 CFR 872.6660
Regulation Name	Porcelain Powder for Clinical Use	Porcelain Powder for Clinical Use
Prescription Use	Rx Only	Rx Only
Indications for Use Statement	The APVolution System is used tofabricate prostheses formissing/damaged teeth. TheAPVolution pressable ceramic ingotsare pressed onto metal alloy(APVolution M) or zirconia(APVolution Z) frames by dentaltechnicians to fabricate ceramicrestorations. APVolution M andAPVolution Z ceramic layeringpowders and/or pastes are used tolayer or build up the pressed ceramicto final tooth morphology.APVolution S ceramic ingots are usedto fabricate all-ceramic restorations.AP stains and glaze are used with theAPVolution ceramic ingots, powdersand/or pastes during the fabricationprocess to achieve the correct shade.	The DCceram System is used tofabricate prostheses formissing/damaged teeth. The DCcerampressable ceramic ingots are pressedonto metal alloy (APVolution M) orzirconia (APVolution Z) frames bydental technicians to fabricate ceramicrestorations. DCceram 12.5 andDCceram 9.2 ceramic layeringporcelains and shades are used to layeror build up the pressed ceramic to finaltooth morphology and shade on theparticular framework (DCceram 9.2zirconia substructures; DCceram 12.5metal substructures). The DCceramconceptPress ceramic ingots are used tofabricate all-ceramic restorations.DCceram conceptArt stains and shadesmay be used with DCceramconceptPress or DCceram 9.2 ceramics.
System Components	APVolution M ceramic ingotsAPVolution Z ceramic ingotsAPVolution S ceramic ingotsAPVolution M porcelain powdersAPVolution Z porcelain powdersAPVolution M opaque ceramic pasteAP stains & glazes	DCceram 9.2 ceramic ingotsDCceram 12.5 ceramic ingotsconceptPress ceramic ingotsDCceram 9.2 liner/layering porcelainDCceram 12.5 liner/layering porcelainDCceram 12.5 opaque ceramic pasteconceptArt stains, shades & glazes
Range of Vita® Tooth Shades	A1 - D4	A1 - D4

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	Aesthetic-Press APVolution System(current submission)	Ceramay DCceram System(K141400)
ISO 6872 Type I/II, Class 1aMaterials	APVolution M & APVolutionceramic ingots	DCceram 9.2 & DCceram 12.5ceramic ingots
	APVolution M & APVolution Zporcelain powders	DCceram 9.2 & DCceram 12.5porcelain powders
	APVolution M opaque ceramic pasteAP stains & glazes	DCceram 12.5 opaque ceramic pasteconceptArt stains, shades & glazes
ISO 6872 Type II, Class 4bMaterials	APVolution S ceramic ingots	conceptPress ceramic ingots

ISO 7405 Biocompatibility	ISO 10993-5 cytotoxicity test: L929cell monolayer proliferation/inhibitionduring contact with extended (7 day)extraction using DMSO in completecell culture medium	Meets requirements of ISO 7405Dentistry – Evaluation ofBiocompatibility of Medical DevicesUsed in Dentistry
ISO 6872 Performance Testing	• Identification of Types & Classesof System Components• Uniformity• Freedom from ExtraneousMaterials• Mixing & Condensation Properties(Class I Ceramics)• Physical & Chemical Properties• Flexural Strength• Linear Thermal ExpansionCoefficient• Glass Transition Temperature• Chemical Solubility• Radioactivity	Meets performance testingrequirements of ISO 6872 Dentistry –Dental Ceramics
Sterile Device	No	No
Prescription Only	Yes	Yes
Single Use	Yes	Yes

Performance Testing:

The APVolution System components have been tested to confirm compliance with ISO 6872 Dentistry - Ceramic Materials. This Abbreviated 510(k) submission includes a Declaration of Conformity to the performance testing methods and acceptance criteria defined in ISO 6872. The specific inspections and tests included in this declaration are listed in the table above. This submission also includes biocompatibility test reports to demonstrate that the APVolution System components meet the biocompatibility requirements described in ISO 7405:2008 Dentistry -Evaluation of biocompatibility of medical devices used in dentistry. Biocompatibility testing consisted of ISO 10993-5 cytotoxicity testing where the proliferation or inhibition of an L929 cell monolayer was evaluated following direct contact with an extended-time (7 day) extract of the system components using DMSO in complete culture medium. The APVolution components met all requirements of the ISO 6872 and ISO 7405 standards.

Conclusion:

The Aesthetic-Press APVolution System has been demonstrated to be substantially equivalent to the predicate device as demonstrated through comparison of the system indications for use,

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description of system components, biocompatibility testing in accordance with ISO 7405, performance testing in accordance with ISO 6872, and device labeling.

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.