Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

Device Description

The Trusana device is a light-activated denture base resin, offered in four shades.
The Trusana resin is used with patient-specific *.stl files provided by the dental practitioner to fabricate the customized denture bases for removable denture devices using a 3D (additive) printer and curing unit.
The proprietary light-curable resin is composed of methylacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator and pigments for color
It is used by dental laboratories and dental practices to make the denture bases for the removable dentures.
The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles.
Trusana resin is an alternative material to heat-curable and auto-polymerizable resins.

AI/ML Overview

The provided text describes the 510(k) premarket notification for Trusana™, a light-activated denture base resin. It includes acceptance criteria and performance data for the device, but it does not describe studies proving device performance with AI assistance, MRMC studies, or multi-reader studies establishing ground truth by medical experts. The context is a material science and manufacturing regulatory submission, not an AI/software medical device submission.

Therefore, many of the requested details, particularly those related to AI, human readers, ground truth establishment by medical experts, and training/test set sample sizes for AI models, are not present in the provided document.

Here's an analysis of the information that is available in relation to your request:

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

The document provides a comparison table between the new device (Trusana™) and the primary predicate device (NextDent Denture 3D+), with specific performance characteristics based on ISO 20795-1.

Acceptance Criteria and Device Performance (for Trusana™ vs. Predicate)

Characteristic	Acceptance Criteria (Trusana™ - based on "or more/less" relative to ISO standard)	Reported Performance (Trusana™)	Predicate Performance (NextDent Denture 3D+)	ISO Standard Reference (Implicit Acceptance Metric)
Cured Product Characteristics:
Sterility	Non-sterile	Non-sterile	Non-sterile	N/A
Ultimate Flexural Strength	65 MPa or more (per ISO 20795-1)	(Performance implicitly met as it is cleared)	84 MPa (per ISO 20795-1)	ISO 20795-1
Flexural (Bending) Modulus	2000 MPa or more (per ISO 20795-1)	(Performance implicitly met as it is cleared)	2383 MPa (per ISO 20795-1)	ISO 20795-1
Water Sorption	32 µg/mm3 or less (per ISO 20795-1)	(Performance implicitly met as it is cleared)	28 µg/mm3 (per ISO 20795-1)	ISO 20795-1
Water Solubility	1.6 µg/mm3 or less (per ISO 20795-1)	(Performance implicitly met as it is cleared)	0.1 % (w/w) (per ISO 20795-1)	ISO 20795-1
Residual monomer	0% (per ISO 20795-1)	(Performance implicitly met as it is cleared)	<0.1% (w/w) (per ISO 20795-1)	ISO 20795-1
Biocompatibility	Biocompatible, according to ISO 10993 testing	Biocompatible	Biocompatible	ISO 10993

Note: The document states that "The following specification requirements of the 3D-printed denture base material samples were tested and have been met," implying that Trusana™ indeed meets the listed ISO criteria. The exact numerical performance values for Trusana™ are not explicitly stated for each metric as they are for the predicate, but their compliance is asserted.

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

Sample Size: The document does not specify the exact sample sizes (number of specimens) used for each of the laboratory tests (e.g., flexural strength, water sorption). It mentions "samples were tested".
Data Provenance: Not specified. The testing was conducted to evaluate the performance of a "manufactured denture base". It is laboratory testing of a material, not data from human subjects or clinical cases. The manufacturer is Myerson, LLC, located in Chicago, IL, USA. No information on country of origin of material tests is provided.
Retrospective or Prospective: Not applicable as this refers to material property testing in a lab setting, not a clinical 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)

This is not applicable. The "ground truth" for this device's performance is established by physical and chemical property measurements according to established international standards (ISO 20795-1, ISO 10993) in a laboratory setting, not by human expert interpretation of clinical data or images.

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

Not applicable. As above, this is material property testing, not an assessment requiring human adjudication of subjective data.

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 denture base resin, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

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

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

The "ground truth" for this device's performance is defined by physical and chemical measurement standards (e.g., MPa for strength, µg/mm3 for sorption) established by the specified ISO standards (ISO 20795-1 for Dentistry - Base Polymers and ISO 10993-1 for Biocompatibility). This is objective, quantitative data measured in a laboratory, not clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. This device is a material, not an AI model requiring a training set.

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

Not applicable. See #8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

April 13, 2023

Myerson, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 306 Turnberry Court Lebanon, Indiana 46052

Re: K230098

Trade/Device Name: TrusanaTM Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 11, 2023 Received: January 13, 2023

Dear Patsy Trisler:

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

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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 mediation-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,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230098

Device Name

Trusana™

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)

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K230098 -510(k) Summary

I. SUBMITTER
Submitter Name:	Myerson, LLC
Submitter Address:	5106 North Ravenswood AvenueChicago, IL 60640-2713
Contact Person:	James H. Swartout, President & CEO
Email:	jswartout@myersontooth.com
Telephone:	312.432.8200
Date Prepared:	January 11, 2023
II. DEVICE
Trade Name:	Trusana™
Common Name	Denture Resin
Classification:Name NumberProduct CodeDevice Class	Denture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760EBIII
III. PREDICATE DEVICE
PrimaryPredicate Device:	K191497, NextDent Denture 3D+, Vertex-Dental BV
Reference Device	none

IV. INDICATIONS FOR USE STATEMENT

V. DEVICE DESCRIPTION

DeviceIdentification	The Trusana device is a light-activated denture base resin, offeredin four shades.
TechnologicalCharacteristics	The Trusana resin is used with patient-specific *.stl files provided bythe dental practitioner to fabricate the customized denture bases forremovable denture devices using a 3D (additive) printer and curingunit.The proprietary light-curable resin is composed of methylacrylatedmonomers, methacrylated carboxylic acid, phosphine oxide initiatorand pigments for colorIt is used by dental laboratories and dental practices to make thedenture bases for the removable dentures.

DeviceIdentification

The Trusana device is a light-activated denture base resin, offeredin four shades.

TechnologicalCharacteristics

The Trusana resin is used with patient-specific *.stl files provided bythe dental practitioner to fabricate the customized denture bases forremovable denture devices using a 3D (additive) printer and curingunit.The proprietary light-curable resin is composed of methylacrylatedmonomers, methacrylated carboxylic acid, phosphine oxide initiatorand pigments for colorIt is used by dental laboratories and dental practices to make thedenture bases for the removable dentures.

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The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles.
Trusana resin is an alternative material to heat-curable and auto-polymerizable resins.
VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
	NEW DEVICE	PRIMARY PREDICATE
510(k) NUMBER;DEVICE NAME;MANUFACTURER	K230098Trusana™Myerson, LLC	K191497NextDent Denture 3D+Vertex-Dental BV
PRODUCT CODEREGULATORY NAME	EBIDenture Relining, Repairing, orRebasing Resin	EBIDenture Relining, Repairing, orRebasing Resin
CLASSIFICATION	21 CFR 872.3760	21 CFR 872.3760
INDICATIONS FORUSE	Trusana™ resin is intended to 3Dprint denture base for use inmaking removable full and partialdentures or overdentures.Trusana™ is intended exclusivelyfor professional dental work.Fabrication of denture bases withTrusana™ requires a computer-aided and manufacturing(CAD/CAM) system using theAsiga MAX UV or Asiga PRO 4K3D printer in conjunction with theAsiga Flash curing chamber.	NextDent Denture 3D+ is a light-cured resin indicated for thefabrication of denture basesfabricated in dental laboratories,including full and partial removabledentures. The material is analternative to traditional heat-curedand auto polymerization resins.NextDent Denture 3D+ is intendedexclusively for professional dentalwork. Fabrication of denture baseswith NextDent Denture 3D+ requiresa computer-aided andmanufacturing (CAD/CAM) systemthat includes the following scanner,design software, additive printer andpost-cure unit:Design:Scanner: 3Shape D900Design Software: 3Shape Dental-System 2016 PremiumPrinting:Printer: 3D Systems NextDent 5100Figure 4®; Software: 3D SprintPost-curing:Post-cure unit: NextDent LC-3DPrint Box
INGREDIENTS	Light-curable Resin	Light-curable Resin
MANUFACTURINGTECHNOLOGY TYPE	Additive	Additive
CURED PRODUCTCHARACTERISTICS:
Sterility	Non-sterile	Non-sterile
Ultimate FlexuralStrength	65 MPa or more (per ISO 20795-1)	84 MPa (per ISO 20795-1 –company website)
Flexural (Bending)Modulus	2000 MPa or more (per ISO20795-1)	2383 MPa (per ISO 20795-1 –company website)
Water Sorption	32 µg/mm3 or less (per ISO20795-1)	28 µg/mm3 (per ISO 20795-1 –company website)
Water Solubility	1.6 µg/mm3 or less (per ISO20795-1)	0.1 % (w/w) (per ISO 20795-1 –company website)
Residual monomer	0% (per ISO 20795-1)	<0.1% (w/w) (per ISO 20795-1 –company website)
Biocompatibility	Biocompatible, according to ISO10993 testing	Biocompatible, according to ISO10993 testing (per companywebsite)
VII PERFORMANCE AND SAFETY TESTING
Animal Testing:	This product category does not require animal testing.
Clinical Testing:	This product category does not require human clinical testing.
LaboratoryTesting:	Testing was conducted to evaluate the performance of amanufactured denture base, according to requirements of DIN ENISO 20795-1:2013, Dentistry - Base Polymers.The following specification requirements of the 3D-printed denturebase material samples were tested and have been met:• Surface characteristics• Shape capability• Color and color stability• Translucency• Freedom from porosity• Ultimate Flexural strength• Flexural bending modulus• Bonding to synthetic teeth• Water Sorption• Solubility• Validation of no residual MMA monomer.
Shelf Life Testing:	Validated real-time shelf life of the Trusana resin at time of 510(k)submission is 13 months. Properties tested include chemical andphysical characteristics after storage.
BiocompatibilityTesting:	An assessment, according to ISO 10993-1, based on extractablesand cytotoxicity testing, confirms that Trusana printed denturebase is biocompatible and non-toxic and meets the requirementsfor a device in contact with mucosal membrane for >30 days.
AdditiveManufacturing	Testing, according to FDA's guidance Technical Considerations forAdditive Manufactured Medical Devices, was performed andresults were provided in the 510(k). These tests includedevaluation of all relevant properties of the printed resin using theAsiga machines.
	Further, tests based on considerations of the orientation duringmanufacturing were performed.

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VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES

The intended use, critical specifications, and additive method of manufacturing of Trusana are substantially equivalent to the predicate device. NextDenture 3D+.

While the resin of the predicate is different from Trusana, both are photo-curable resins used in additive manufacturing and are of the same material category.

The additive manufacturing processes both use a resin to fabricate the denture bases using a 3D printer, associated software and curing unit.

The noted differences, in comparison to the predicate device, raise no new questions of safety and effectiveness.

VIX CONCLUSION

Based on the comparisons provided and the data submitted in this 510(k), it can be concluded Trusana™ is substantially equivalent to the predicate device. Myerson's analysis of the resin and its output compared to the predicate show they have the same intended use and similar technological parameters that meet the requirements of ISO 20795-1:2013.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.