Provisional anterior and posterior crowns & bridges
Implant and abutment supported prosthetics.
Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)

Device Description

The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.

AI/ML Overview

The given text is a 510(k) Summary for a dental device (Portux CAD/CAM Disc). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not describe acceptance criteria for an AI/software device, nor does it provide information about a study proving an AI device meets acceptance criteria. Instead, it focuses on the physical and chemical properties of a dental disc material and its equivalence to another dental disc.

Therefore, most of the requested information regarding AI device performance, sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, and training set details cannot be extracted from this document.

The only "acceptance criteria" and "performance data" mentioned in the document relate to the physical properties of the PMMA material, not the performance of an AI or software algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

Acceptance Criteria (for the dental material, not AI): The document lists performance testing standards (ISO 10477 and ISO 20795) and specific physical property requirements for the dental disc material. These are akin to "acceptance criteria" for the material itself.
Reported Device Performance (for the dental material, not AI): The document provides the device's measured physical properties alongside the ISO standard requirements.

What cannot be extracted (as it pertains to AI/software device studies, which are not described in this document):

A table of acceptance criteria and reported device performance for an AI/software device.
Sample sizes used for the test set for an AI/software device.
Data provenance for an AI/software device test set.
Number of experts used to establish ground truth for an AI/software device.
Qualifications of experts for an AI/software device.
Adjudication method for an AI/software device test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done for an AI/software device.
Effect size of human readers improving with AI vs. without AI assistance.
If a standalone (algorithm only) performance study was done for an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
The sample size for the training set for an AI/software device.
How the ground truth for the training set was established for an AI/software device.

Based on the provided text, here is the information that can be extracted, framed within the context of the physical dental disc material:

1. A table of acceptance criteria and the reported device performance (for the dental material):

Physical Property	Acceptance Criteria (ISO Standards)	Reported Device Performance (Portux CAD/CAM Disc)	Equivalence Discussion
Flexural Strength	ISO 10477 ≥50 MPaISO 20795 ≥65 MPa	> 65 MPa	Substantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
Flexural Modulus	ISO 20795 ≥2000 MPa	> 2000 MPa	Substantially Equivalent (Slightly different values doesn't affect intended use; meets ISO standard)
Water Absorption	ISO 10477 ≤40 µg/mm³ISO 20795 ≤32 µg/mm³	≤32 µg/mm³	Substantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
Water Solubility	ISO 10477 ≤7.5 µg/mm³ISO 20795 ≤1.6 µg/mm³	≤1.6 µg/mm³	Substantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
Residual monomer content	ISO 20795 ≤2.2%	≤2.2 %	Substantially Equivalent (Slightly different values doesn't affect intended use; meets ISO standard; comparable to predicate < 1.1%)

2. Sample sized used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test, but standard testing procedures for materials typically involve a defined number of specimens (e.g., n=5 or n=10 per test) to ensure statistical validity. This document does not specify these numbers.
Data Provenance: The tests were performed on "the Subject device" (Portux CAD/CAM Disc) manufactured by New Stetic S.A. in Guarne – Antioquia, Colombia. This is not patient/human data, but material performance data. The tests are laboratory-based, not clinical trials in the sense of patient data collection.

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

N/A. This document describes material performance testing against international standards (ISO), not the establishment of ground truth for an AI model by human experts. The "ground truth" here is the physical measurement against a defined standard.

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

N/A. This is not relevant to material property testing.

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. No AI or software component is described, thus no MRMC study.

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

N/A. No AI or software component described.

7. The type of ground truth used:

The "ground truth" for material properties is established by well-defined, international standard test methods (ISO 10477 and ISO 20795) and the objective physical measurements obtained from those tests. This is not derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

N/A. This is a physical product, not a machine learning model, so there is no "training set."

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

N/A. Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 7, 2019

New Stetic S.A. % Chris Brown Manager Aclivi Consulting 6455 Farley Road Pinckney, Michigan 48169

Re: K192153

Trade/Device Name: Portux CAD/CAM Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, EBI, MQC Dated: July 17, 2019 Received: August 9, 2019

Dear Chris Brown:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192153

Device Name Portux CAD/CAM Disc

Indications for Use (Describe)

For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.

Provisional anterior and posterior crowns & bridges
Implant and abutment supported prosthetics.
Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)

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)

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary New Stetic S.A. Portux CAD/CAM Disc K192153 11/5/2019

5.1 ADMINISTRATIVE INFORMATION

Manufacturer Name	New Stetic S.A.Carrera 53 No. 50 - 09Guarne – AntioquiaColombiaTelephone: +57 4 550 00 00Fax: +57 4 551 31 34	Official Contact	Juan David Jaramillo G. - General Manager
Email:	infocolombia@newstetic.com

5.2 DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Portux CAD/CAM Disc
Common Name:	Crown And Bridge, Temporary Resi
Regulation Name:	Temporary Crown And Bridge Resin
Regulation Number:	21 CFR 872.3770
Device Class:	Class II
Product Code:	EBG, EBI, MQC
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

PREDICATE DEVICE INFORMATION 5.3

The devices within this submission are substantially equivalent in indications, intended use and design principles to the following Primary Predicate device:

510(k)	Primary Predicate Device Name	Company Name
K180578	Harvest Dental Polymer Blocks	Harvest Dental Products, LLC

DEVICE DESCRIPTION 5.4

{4}------------------------------------------------

5.5 INDICATIONS FOR USE

For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.

Provisional anterior and posterior crowns & bridges
Implant and abutment supported prosthetics.
Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)

5.6 EQUIVALENCE TO MARKETED DEVICE

The comparison table below compare the Indications for Use and technological characteristics of the Subject and Primary Predicate devices.

Parameter	Subject Device	Primary Predicate Device	Equivalence Discussion
	Portux CAD/CAM Disc(K192153)New Stetic S.A.	Harvest Dental Polymer Blocks(K180578)Harvest Dental Products, LLC
Regulation Number	21 CFR 872.3770	21 CFR 872.3770	Substantially Equivalent
Regulatory Class	Class II	Class II	Substantially Equivalent
Product Code	EBG, EBI, MQC	EBG, EBI, MQC	Substantially Equivalent
Indication for Use	For the fabrication of crowns, bridgesand structures for implant supportedprovisional removable denture andappliance prosthetics.- Provisional anterior and posteriorcrowns & bridges- Implant and abutment supportedprosthetics.- Partial, complete and hybrid dentureprosthetics (base and teeth) -Removable appliances (splint)	For the fabrication of crowns, bridgesand structures for implant supportedprovisional removable denture andappliance prosthetics.- Provisional anterior and posteriorcrowns & bridges- Implant and abutment supportedprosthetics.- Partial, complete and hybrid dentureprosthetics (base and teeth) -Removable appliances (splint)	Substantially Equivalent
Technology	Blank for dental CAD/CAM	Blank for dental CAD/CAM	Substantially Equivalent
Material Shades	VITA-shades, clear, pink, red	VITA-shades, clear, pink	Substantially Equivalent
Material	PMMA	PMMA	Substantially Equivalent
Biocompatible	Yes	Yes	Substantially Equivalent
OTC or Rx	Rx	Rx	Substantially Equivalent
Sterile	Non-sterile	Non-sterile	Substantially Equivalent
Chemical Composition
Base Material	Polymethyl methacrylate	Polymethyl methacrylate	Substantially Equivalent
Coloring Oxides	< 0.5%	< 1.1%	Substantially Equivalent
Physical Properties
Performance Testing	ISO 10477ISO 20795	ISO 10477ISO 20795	Substantially Equivalent
Flexural Strength	> 65 MPa	> 90 MPa	Substantially EquivalentSlightly different valuesdoesn't affect intendeduse of the device.
	ISO 10477 ≥50 MPaISO 20795 ≥65 MPa
Flexural Modulus	> 2000 MPa	> 2200 MPa	Substantially EquivalentSlightly different valuesdoesn't affect intendeduse of the device.
	ISO 20795 ≥2000 MPa
Water Absorption	≤32 µg/mm³	24 µg/mm³	Substantially EquivalentSlightly different valuesdoesn't affect intendeduse of the device.
	ISO 10477 ≤40 µg/mm³ISO 20795 ≤32 µg/mm³
Water Solubility	≤1.6 µg/mm³	0.0 µg/mm³	Substantially EquivalentSlightly different valuesdoesn't affect intendeduse of the device.
	ISO 10477 ≤7.5 µg/mm³ISO 20795 ≤1.6 µg/mm³
Residual monomer content	≤2.2 %	< 1.1%	Substantially EquivalentSlightly different valuesdoesn't affect intendeduse of the device.
	ISO 20795 ≤2.2%

{5}------------------------------------------------

Minor differences in material properties do not alter or impact the ability of the Subject device to be used for its intended use. In all cases, the Subject device meets the ISO 10477 and ISO 20795 material physical property requirements for these parameters. The Subject device is substantially equivalent to the Primary Predicate device with respect to Indications for Use and technological principles.

5.7 PERFORMANCE DATA

Physical property testing was performed on the Subject device to ISO 10477:2018, Dentistry - Polymerbased crown and veneering materials and ISO 20795-1:2013, Dentistry - Base polymers - Part 1: Denture base polymers. Results are stated in the Substantial Equivalence Comparison table above demonstrating the Subject device meets the property requirements of the referenced standards.

CLINICAL TESTING 5.8

The performance of PMMA as a provisional material in the clinical environment has been well established. No clinical testing was required to support substantial equivalence between the Subject and Primary Predicate devices. No clinical data is included in this submission.

5.9 BIOLOGICAL TESTING

The Subject device was evaluated to the Irritation and Sensitization Biocompatibility Endpoints according to ISO 10993-10:2010/(R)2013 and evaluated for Cytotoxicity according to ISO 10993-5:2009. Test results demonstrate suitable biocompatibility for the Subject device.

5.10 CONCLUSION

Overall, the Subject device has the following similarities to the legally marketed Primary Predicate device:

Has the same Indications for Use
Has the same Technological Characteristics
Is fabricated from the same material (PMMA)
Are both Prescription Use only
Supplied as non-sterile

Therefore, the Portux CAD/CAM Disc Subject device is substantially equivalent to the Harvest Dental Polymer Blocks (K180578) Primary Predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.