The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.

Device Description

The ECLIPSE® WAX REMOVER is an accessory to the Trubyte® Denture Base Resin System (Eclipse® Prosthetic Resin System). It facilitates the effective removal of wax from cured Eclipse® resin substructures and promotes adhesion to other acrylic resins.

AI/ML Overview

The provided text is a 510(k) summary for the ECLIPSE WAX REMOVER, a dental device. It does not describe an AI/ML-enabled medical device or any study that proves its performance against acceptance criteria in the way typically expected for such technologies (e.g., using metrics like sensitivity, specificity, or AUC).

Instead, this document is for a conventional medical device (a chemical accessory for denture fabrication). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device and confirming basic safety and biocompatibility, not on evaluating the performance of an algorithm.

Here's a breakdown of why many of your requested points cannot be answered from this document and what information can be extracted:

Information Not Applicable or Not Found in the Document (for an AI/ML context):

A table of acceptance criteria and the reported device performance (in an AI/ML sense): Not available. The document refers to "performance data" generally, but not specific metrics against acceptance criteria for an AI model.
Sample sized used for the test set and the data provenance: Not applicable for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a chemical product isn't established by expert consensus on images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" here would be established chemical or physical properties, not diagnostic classifications.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information Applicable (Interpreted for a Conventional Device):

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied from the document):
  - Facilitates effective removal of wax from cured Eclipse® resin substructures.
  - Promotes adhesion to other acrylic resins.
  - Components previously used in legally marketed devices and/or found safe for dental use.
  - Passes biocompatibility testing for cytotoxicity.
  - Substantial equivalence to the predicate device (Trubyte Denture Base Resin System, K011560) for its intended use.
- Reported Device Performance:
  - "We believe that the prior use of the components of ECLIPSE® WAX REMOVER in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the ECLIPSE® WAX REMOVER for the indicated use."
  - Specifically states: "ECLIPSE® WAX REMOVER has been evaluated and passed biocompatibility testing for cytotoxicity."
Sample sized 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 "performance data" or "biocompatibility testing."
- Data provenance is not mentioned.
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)
- Not applicable as this is a chemical product, not an AI/ML diagnostic device requiring expert ground truth in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. This is not an AI-enabled device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-enabled device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biocompatibility: established testing standards for cytotoxicity.
- For performance (wax removal/adhesion): Likely laboratory testing against established benchmarks or comparative testing against the predicate device, but specific details are not provided.
The sample size for the training set
- Not applicable; this is not an AI/ML device.
How the ground truth for the training set was established
- Not applicable; this is not an AI/ML device.

In summary, this document describes a traditional medical device (a chemical solution) being brought to market via the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device and basic safety/performance, not the evaluation of an AI/ML algorithm.

Summary

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K061580

JUL 2 8 2006

510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT:	Helen Lewis
DATE PREPARED:	June 2, 2006
TRADE OR PROPRIETARY NAME:	ECLIPSE WAX REMOVER
CLASSIFICATION NAME:	Denture relining, repairing, or rebasing resin,872.3760
PREDICATE DEVICES:	Trubyte Denture Base Resin System, K011560

DEVICE DESCRIPTION:

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in ECLIPSE® WAX REMOVER have been used in legally marketed devices and/or were found safe for dental use. ECLIPSE® WAX REMOVER has been evaluated and passed biocompatibility testing for cytotoxicity.

We believe that the prior use of the components of ECLIPSE® WAX REMOVER in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the ECLIPSE® WAX REMOVER for the indicated use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2006

DENTSPLY International. Incorporated Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs Dentsply Prosthetics Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K061580

Trade/Device Name: ECLIPSE® WAX REMOVER Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 2, 2006 Received: June 7, 2006

Dear Ms. Lewis:

We have reviewed vour 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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 - Mr. Lewis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely yours.

Chiu Lin. Ph.D.

[Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known): K061580

ECLIPSE® WAX REMOVER Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) ANDIOR

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)

Robert S. Betz DDS for Dr. Susan Renner

K061580

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.