OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist Patches for Dry Mouth provides temporary relief for dry mouth.

Device Description

OraMoist® Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and dissolves slowly moisturizing the buccal cavity for hours. The tablets are packaged individually in low density polyethylene foil. Each tablet consists of a mixture of electrolytes, natural lubricants, flavoring agents, and enzymes, and an adherent polymer.

AI/ML Overview

The provided text describes a 510(k) submission for the OraMoist® Patches for Dry Mouth, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a formalized study.

Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in a 510(k) summary for this type of device.

Below is an attempt to address the applicable parts of your request based on the provided document:

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

For a 510(k) submission of this nature, explicit "acceptance criteria" for clinical performance are not typically presented in a quantifiable manner as they would be for a novel device requiring extensive clinical trials. Instead, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. The "performance" is implicitly tied to demonstrating similar safety and effectiveness to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device must be safe for its intended use.	Not explicitly detailed in quantifiable metrics. Implied by substantial equivalence to a predicate and the nature of the device components.
Effectiveness: Provides temporary relief for dry mouth.	"Clinical investigations in patients with xerostomia have been conducted with OraMoist® Patches for Dry Mouth." (Specific results not detailed beyond supporting equivalence.)
Adhesion/Dissolution: Achieves slow dissolution and adheres to oral mucosa.	"In Vitro erosion time (standard USP dissolution test) and clinical investigations...have been conducted." "OraMoist® Patch for Dry Mouth dissolves slowly moisturizing the buccal cavity for hours."
Substantial Equivalence: Similar intended use, claims, and mechanism of action to predicate.	"OraMoist® Patches for Dry Mouth is substantially equivalent to the predicate device based on components, claims, and intended use with the mechanism of action (adherence device based on components, and differentiating OraMoist® Patches for Dry Mouth from the predicate device lozenge form."

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

The document mentions "clinical investigations in patients with xerostomia have been conducted with OraMoist® Patches for Dry Mouth." However, it does not provide details on:

The sample size of these clinical investigations.
The country of origin of the data.
Whether the study was retrospective or prospective.

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 information is not provided in the submission. The "ground truth" for a device like artificial saliva is typically patient-reported efficacy (symptomatic relief) rather than expert interpretation of images or other objective measurements that require expert consensus.

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

This information is not provided and is generally not applicable to the documentation for this type of device when demonstrating substantial equivalence. Adjudication methods are typically used in studies involving expert interpretation, often for diagnostic devices.

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

An MRMC comparative effectiveness study was not performed, nor would it be relevant for this type of medical device (artificial saliva patch). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance to measure performance improvement.

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

This concept is not applicable to a physical device like an artificial saliva patch. "Standalone performance" refers to the performance of an algorithm or AI system operating entirely independently, without human interaction.

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

The "ground truth" for a device addressing symptomatic relief of dry mouth would primarily be patient-reported outcomes data, specifically regarding the reduction of dry mouth symptoms (xerostomia). The document states "clinical investigations in patients with xerostomia have been conducted," implying that patient feedback on symptom relief would form the basis of effectiveness assessment.

8. The sample size for the training set

This is not applicable. This device is a physical product (a patch), not an AI algorithm that requires a "training set" of data.

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

This is not applicable as there is no "training set" for this device.

Summary

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ડ. 510(k) Summary

Submission Application and Correspondence

Name of Device:	OraMoistR Patches for Dry Mouth
Trade/Proprietary/Model Name:	OraMoistR Patches for Dry Mouth
Common or Usual Name:	Saliva, Artificial
Classification Names:	Dental; Saliva, Artificial

Devices to Which New Device is Substantially Equivalent

Company	Device	K Number
Scandinavian Formulas	SalivaSure Tablets	K051409

Device Description

Statement of Intended Use

OraMoist® Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist® Patches for Dry Mouth provides temporary relief for dry mouth.

OraMoists Patches for Dry Mouth is intended for Over-The-Counter (OTC) use

Summary of Technological Characteristics of the Device Compared to the Predicate Devices

The subject device (OraMoist® Patches for Dry Mouth) is a time-released patch that adheres to the oral mucosa. The adhesion is achieved by the addition of an approved biodegradable polymer to the surface of one side of the patch (tablet). The inactive ingredients of the patch provide a means for slow dissolution of the active ingredients (electrolytes, natural lubricants, flavoring agents, and enzymes) responsible for promoting lubrication of the oral mucosa. The predicate device (SalivaSure) consists of similar components to promote lubrication of the oral mucosa, however, the delivery is in the form of a lozenge which is unfixed in the oral cavity. OraMoist® Patch for Dry Mouth dissolves slowly moisturizing the buccal cavity for hours compared to the predicate device whose label recommends 1 lozenge per hour for severe dry mouth.

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Revised 501(K) Notification Submission, K122663/S001 Device Name: OraMoist® Patches for Dry Mouth Divke Framer - Ruantum, Inc., 754 Washington Street, Eugene, Oregon 97401

Substantial Equivalence Comparison Chart

Product Name	OraMoistR	SalivaSure
Method Of Use	Ready to Use	Ready to Use
No. Applications/day	Take as needed	Take as needed
Claim	Symptomatic Relief	Symptomatic Relief
Area of Use	Oral Cavity	Oral Cavity
Disease State	Xerostomia	Xerostomia
Type of Product	Lozenge	Time-release patch
Presentation	Non-sterile	Non-sterile

Tests and Conclusions

In Vitro erosion time (standard USP dissolution test) and clinical investigations in patients with xerostomia have been conducted with OraMoists Patches for Dry Mouth.

In conclusion, OraMoist® Patches for Dry Mouth is substantially equivalent to the predicate device based on components, claims, and intended use with the mechanism of action (adherence device based on components, and mrifferentiating OraMoist® Patches for Dry Mouth from the predicate device lozenge form.

Correspondence

Quantum, Inc. 754 Washington Street Eugene, Oregon 97401 541-345-5556 Eve McClure, President Contact Person:

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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 bird-like figure with three wing-like shapes.

Public Health Service

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

May 30, 2013

Quantum, Incorporated C/O Mr. Fred Ma Medical Quality International, Limited Liability Company 7195 Longview Drive CLEVELAND OH 44139

Re: K122663

Trade/Device Name: OraMoist® Patches for Dry Mouth Regulation Number: Unclassified Regulation Name: Artificial Saliva Regulatory Class: Unclassified Product Code: LFD Dated: January 14, 2013 Received: April 22, 2013

Dear Mr. Ma:

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, 1Drug, 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Susan Runner, DDS, MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000879
Date: 2013.05.30 15:05:21 -04'00'

Anthony D. Watson, B.S., M.S., M.B.A.
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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Revised 501(K) Notification Submission, K122663/S001 Device Name: OraMoist® Patches for Dry Mouth 510(k) Submitter: Quantum, Inc., 754 Washington Street, Eugene, Oregon 97401

Indications for Use Statement

OraMoist Patches for Dry Mouth Device Name:

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(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)

Digitally signed by Mary S. Runner

-5
DN: c=US, o=U.S. Government,
au=HHS, ou=FDA, ou=People,
Susan Runner, DOS, MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000
87950
Date: 2013.05.17 09:52:55 -04'00'

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

N/A