The Ascent Dental Cleanser is a water-based tooth cavity preparation cleanser containing chlorhexidine gluconate and a solvent. This composition, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign material. The cleanser is dispensed from a prefilled applicator directly to the desired site. The applicator may be in the form of a one-time unit dose configuration, or may be supplied in a larger prefilled quantity that accommodates single-use disposable tips of varying size and length to accommodate the needs of a particular procedure.

AI/ML Overview

Here's an analysis of the provided text regarding the Ascent Dental Cleanser's acceptance criteria and the study proving it, based on the provided document.

It's important to note that the provided document is a 510(k) Summary and the associated FDA approval letter for a dental cleanser, not an AI medical device. Therefore, the questions related to AI device performance metrics (MRMC studies, stand-alone algorithm performance, training set details, ground truth establishment for AI) are not applicable (N/A) to this specific submission. This document focuses on demonstrating substantial equivalence to a predicate device for a physical product, not an AI algorithm.

Acceptance Criteria and Device Performance for Ascent Dental Cleanser

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Purpose of the device: Cleansing and disinfecting cavity preparations.	The Ascent Dental Cleanser is intended for cleaning and disinfecting cavity preparations in conjunction with dental restorative procedures.
General Composition: Similar to predicate device (Chloraprep - K021131), containing chlorhexidine gluconate and a solvent.	The Ascent Dental Cleanser is a water-based tooth cavity preparation cleanser containing chlorhexidine gluconate and a solvent. The submitted and predicate device are composed of similar substances, with similar active constituents in similar concentrations.
Methods of Application: Similar to predicate device.	dispensed from a prefilled applicator directly to the desired site. The applicator may be in the form of a one-time unit dose configuration, or may be supplied in a larger prefilled quantity. Both have similar methods of application.
Indications for Use: Cleansing and disinfecting cavity preparations in conjunction with dental restorative procedures.	"Ascent Dental Cleanser is indicated for: The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures." Both have similar indications for use.
Safety and Effectiveness: Does not raise new issues regarding safety and/or effectiveness compared to the predicate.	The Conclusion states, "The Ascent Dental Cleanser is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, general composition, methods of application, and indications for use without raising any new issues regarding safety and/or effectiveness."

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

The provided document does not describe a test set in the context of clinical trials or data-driven performance evaluation for an AI device. This submission is for a physical medical device (dental cleanser) seeking substantial equivalence based on its formulation, intended use, and application methods compared to an already marketed predicate device. The "Performance Data" section merely refers to "Part 7: Performance Data," but this detailed report is not included in the provided text. However, such a report for this type of device typically involves bench testing, biocompatibility, and potentially in-vitro studies, not patient data in the sense of a "test set" for an algorithm.

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

N/A – This is not an AI device, and the concept of an expert-established "ground truth for the test set" as relevant to AI performance metrics does not apply here.

4. Adjudication Method for the Test Set

N/A – Same as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

N/A – This is not an AI-assisted diagnostic or therapeutic device.

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

N/A – This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For this type of traditional medical device, "ground truth" would not be established in the same way as for an AI algorithm. Instead, its "truth" or efficacy is demonstrated through:

Chemical composition analysis: Verifying the presence and concentration of active ingredients.
Biocompatibility testing: Ensuring the materials are safe for biological contact (as mentioned: "Exact information regarding the material's constituents is found in Part 8: Biocompatibility Assessment").
Bench testing/in-vitro studies: To show its ability to dislodge unwanted material and disinfect, likely through laboratory experiments on simulated cavity surfaces or bacterial cultures.
Comparison to predicate device: The fundamental "ground truth" of this submission is that it is chemically, functionally, and biologically equivalent to a device already deemed safe and effective.

8. The Sample Size for the Training Set

N/A – This is not an AI device.

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

N/A – This is not an AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K070070" written in a handwritten style. The text appears to be a code or identifier. A line is drawn underneath the text, possibly indicating emphasis or underlining.

510(k) Summary of Safety and Effectiveness

CAO GROUP 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801.256.9282 Fax: 801.256.9287 www.caogroup.com Robert K. Larsen, Operations Director Preparation Date: May 14, 2007

MAY 2 5 2007

Device Name:

Trade Name:	Ascent Dental Cleanser
Common Name:	Dental cleansing material
Product Classification:	Varnish, Cavity (21 CFR 872.3260, Product Code: LBH)

Legally Marketed Predicate Devices for Substantial Equivalence:

Chloraprep, Manufactured by Centrix, Inc. . 510(k) Number: K021131

Rationale for Substantial Equivalence:

The aforementioned device shares similarities for the purpose of cleansing cavities in conjunction with dental restorative procedures. This device features similar indications for use and application methods to the predicate device.

Description of Submitted Device:

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K0700870

Intended Uses of the Ascent Dental Cleanser:

The Ascent Dental Cleanser is intended for cleaning and disinfecting cavity proparations in conjunction with dental restorative procedures. The water-based preparation, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign matcrial. The amount of time the material is introduced at the site is determined by the dental professional as dictated by the location of the site and the extent of cleansing that is required. This material is used independently or in conjunction with other devices to achieve the level of cleansing desired.

Technological Characteristics of Substantial Equivalence:

Both the submitted and predicate device are composed of similar substances, with similar active constituents in similar concentrations. Both have similar indications for use. Both have similar methods of application. Both are used in conjunction with dental restorative procedures. A comparison table of the predicate device and submitted device is contained in Part 7: Performance Data.

Performance Standards:

None

Performance Data

See Part 7: Performance Data

Conclusion

The Ascent Dental Cleanser is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, general composition, methods of application, and indications for use without raising any new issues regarding safety and/or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side. The bird is depicted in a simple, graphic style, with bold black lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert K. Larsen Operations Director CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084

MAY 2 5 2007

Re: K070070

Trade/Device Name: Ascent Dental Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: May 14, 2007 Received: May 15, 2007

Dear Mr. Larsen:

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.

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 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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Page 2 - Mr. Larsen

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 and ilsuing (21 et read 007), 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suzette Y. Mckend md.

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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Ko70070

Indications for Use

510(k) Number (if known):

Device Name: Ascent Dental Cleanser

Indications For Use:

Ascent Dental Cleanser is indicated for:

· The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
------------------	---	----	----------------------	--

(Per 21 CFR 801.109)

Kai Malay for MSE

ospial,

KO700702-1

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.