Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only.

Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for single use only.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental device, the Rhondium One-Visit-Crown (OVC). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the context of diagnostic performance metrics like sensitivity and specificity.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document. This submission focuses on non-clinical performance and a comparison of technological characteristics to establish equivalence.

Here's a breakdown of the performance data and equivalence demonstration, addressing the relevant points from your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, there are no "acceptance criteria" in the sense of predefined diagnostic performance thresholds (e.g., sensitivity, specificity). Instead, the device demonstrates substantial equivalence through a series of non-clinical tests and a comparison of its technological characteristics to a predicate device.

The document lists the following performance tests and their purpose:

Test	Purpose	Reported Performance
Product Shelf Life Testing	To ensure the device maintains its properties and safety over its intended shelf life.	Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed in this summary, but implied to be acceptable for substantial equivalence).
Biocompatibility Testing (ISO 10993-1, ISO 10993-5)	To evaluate the biological response to the device materials, including cytotoxicity.	Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence).
Flexural Strength Testing	To assess the material's resistance to bending or deformation.	Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence).
Static Compressive Strength Testing	To assess the material's resistance to compression.	Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence).
Resin Depth of Cure Testing	To measure how deeply the light-cured resin material hardens. This is crucial for the OVC's function, as it has an uncured sub-layer for customization that needs to cure properly upon placement.	Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence).
Comparison of Technological Characteristics with Predicate Device (K072733)	To demonstrate that the subject device's design, material, intended use, and other features are sufficiently similar to a legally marketed device that it raises no new questions of safety or effectiveness.	"Any differences in the technological characteristics between the subject device and the predicate devices do not affect substantial equivalence." (Implies that the comparison was favorable)

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of diagnostic performance evaluation. The performance data discussed are from non-clinical laboratory tests. Therefore, information about sample sizes for a test set and data provenance (country of origin, retrospective/prospective) for clinical data is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a physical dental restoration, not an AI/diagnostic tool requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no "test set" in the context of human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a physical dental material, not an AI-assisted diagnostic system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical dental restoration, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. For the non-clinical tests, the "ground truth" would be the scientifically established physical or biological properties of the materials as measured by standardized testing methods. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the predicate device (K072733).

8. The Sample Size for the Training Set

This is not applicable. The device is a manufactured product; it does not involve AI algorithms that require training sets.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons mentioned above.

In summary:

The provided document is an FDA 510(k) summary for a dental restorative device. It establishes substantial equivalence through non-clinical performance testing of the device's material properties (shelf life, biocompatibility, mechanical strength, depth of cure) and a detailed comparison of its technological characteristics with a legally marketed predicate device. The performance data demonstrate that the device meets the necessary safety and effectiveness criteria for its intended use, analogous to how an AI device would meet acceptance criteria, but through different types of evidence.

Summary

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

May 15, 2015

Rhondium Ltd. c/o Mr. Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego California, 92130

Re: K143694

Trade/Device Name: Rhondium One-Visit-Crown (OVC) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 14, 2015 Received: April 15, 2015

Dear Mr. Thomas:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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)

K143694

Device Name

Rhondium One-Visit-Crown (OVC)

Indications for Use (Describe)

Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.

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.

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510(k) Summary

Rhondium, Ltd

Rhondium One-Visit-Crown (OVC)

K143694

May 11, 2015

ADMINISTRATIVE INFORMATION

Manufacturer Name	Rhondium, Ltd4 Sheffield StreetKatikati, 3129, New ZealandTelephone: +64 7 549 5566Fax: +64 7 549 1461
Official Contact	Greer FrickerR&D Projects and Regulatory Manager
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. LarsonPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Rhondium One-Visit-Crown (OVC)
Common Name	Dental material, filling/restorative, polymer based
Classification Name	Tooth Shade Resin Material
Classification Regulations	21 CFR 872.3690, Class II
Product Code	EBF
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Device Branch

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510(k) Summary K143694

INTENDED USE

Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.

DEVICE DESCRIPTION

PERFORMANCE DATA

Performance testing to demonstrate substantial equivalence included methods described in the following standards: ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity; and ISO 4049 Dentistry – Polymer-Based Restorative Materials. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: product shelf life testing, biocompatibility testing, flexural strength testing, static compressive strength testing, and resin depth of cure testing. No clinical data were included in this submission.

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EQUIVALENCE TO MARKETED DEVICE

Rhondium, Ltd submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K072733, 3M™ ESPE™ Adult Crown, 3M ESPE Dental Products;

K050401, Ceramage, ShoFu Dental Corporation;

K052501, Resin Tooth Bonding Agent, Cosmedent, Incorporated; and

K092319, Star VPS, First Half, First Quarter, Danville Materials, Incorporated.

The primary predicate device is K072733. A comparison of the technological characteristics of the subject device and the predicate device K072733 is provided in the following table.

	Subject Device	Predicate Device
Comparison	Rhondium LtdOne-Visit-Crown (OVC)K143694	3M ESPE Dental Products3M™ ESPE™ Adult CrownK072733
Crown Description	Preformed single tooth crown for one visitrestoration	Preformed single tooth crown for one visitrestoration
Teeth to be Restored	Upper and lower premolars and molars	Upper and lower canines, premolars, and molars
Specific Crown Designs	N=8 designs :Upper Premolar, Upper Molar, Lower Premolar,Lower MolarEach in Left and Right designs	N=5 designsCanine, Upper Premolar, Upper Molar, LowerPremolar; Lower Molar
Crown Sizes	Each design provided in 6 sizes:XS, S, M, L, XL, XXL	Each design provided in 2 sizes, except LowerPremolar (1 size)
Crown Material	Light-cured polymer composite resin	Light-cured composite
Crown Try-in (Trial)Material	OVC ReplicaVinyl polysiloxane	None
Sizing Device Material	OVC Selector KeyPolycarbonate	3M ESPE Crown Size ToolMaterial not stated
Other Accessory	OVC Wedgespolyacetal resin	None

The subject device and the predicate device K072733 have the same intended use and very similar indications for use (restoration of permanent teeth with a single unit crown). The subject device and the predicate K072733 are provided in a range of designs and sizes to restore the premolars and molars of the upper and lower jaw. The subject device and the predicate K072733 encompass similar ranges of physical dimensions and characteristics, including design and dimensions, and both are made of light-cured resin materials. The subject device and the predicate devices are provided nonsterile for single use only.

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The subject device consists of a fully-cured layer of tooth shade resin, a bonding layer, and a layer of uncured tooth shade resin to allow for customization and to assist with a cohesive fit of the crown to the prepared tooth.

Any differences in the technological characteristics between the subject device and the predicate devices do not affect substantial equivalence.

CONCLUSION

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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.