ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors.

The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression.

Once the impression has cured any excess material is trimmed with a sharp knife.

Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.

AI/ML Overview

The provided text describes a 510(k) submission for a dental device, "ProSoft™ Denture Reliner." However, it does not include information about AI algorithms or studies that would typically relate to the acceptance criteria and performance metrics asked for in the prompt. The device is a physical product (denture reliner kit) and the evaluation focuses on substantial equivalence to predicate devices based on non-clinical bench testing, not AI performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the provided document.

Here's an analysis of what is available in the document, framed as closely as possible to your request:

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

Acceptance Criteria (Implied)	Reported Device Performance
Functionality (as per FDA Guidance Document): The device performs its intended function as an over-the-counter temporary denture reliner.	Bench testing assessed functionality. Analysis "showed that the devices are substantially equivalent" to the predicate device (RELINE-IT). "Both devices form a soft, temporary denture base to relieve loose, irritating dentures resulting in substantial equivalence in regards to safety and effectiveness." The subject device is a self-curing reliner, while the predicate cures with hot water, but "the same results are achieved."
Biocompatibility	Supporting documentation was supplied. Analysis "showed that the devices are substantially equivalent."
Substantial Equivalence to Predicate Device	The device was determined to be "substantially equivalent" to predicate devices (RELINE-IT and Tempo Tissue Conditional Reliner) in intended use, operation, safety, and function.

Explanation of "Acceptance Criteria": For a 510(k) submission of this type of device, the primary "acceptance criterion" from a regulatory perspective is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device is as safe and effective as the predicate. The document indicates that the device met this criterion through non-clinical bench testing and biocompatibility assessments.

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

Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used in the non-clinical bench testing. The document states "Bench testing was performed" and "Comparative testing data was provided" but does not specify the sample size of the materials or tests conducted.
Data Provenance: The testing was "performed by a third party laboratory." The country of origin and whether the data was retrospective or prospective are not mentioned, but given it's a 510(k) in the US, it's presumed to be for the US market. The testing is implied to be prospective for the purpose of the submission.

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)

Not applicable. This device does not involve a diagnostic or interpretive function that would require "experts to establish ground truth" as it would for an AI-powered image analysis device. The "ground truth" for its performance is assessed via established physical and chemical test methods.

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

Not applicable. Adjudication methods like 2+1 are relevant for discrepancies in expert interpretations, which is not pertinent to this device's evaluation.

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

No. An MRMC study was not done. This device is a physical denture reliner, not an AI-assisted diagnostic tool or an imaging device. Clinical testing was explicitly not conducted ("Clinical testing was not conducted").

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

Not applicable. This device is a physical product and does not have an AI algorithm.

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

Type of Ground Truth: For the functionality and biocompatibility, the "ground truth" would be established by established scientific and engineering principles, material science standards, and accepted testing protocols (e.g., for strength, adhesion, biocompatibility through ISO standards or similar). The FDA Guidance Document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits" serves as a benchmark for what needs to be tested. The "ground truth" for showing substantial equivalence essentially means demonstrating that the new device's performance profiles, as measured by these tests, are comparable to those of the predicate device within acceptable limits.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.

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

Not applicable. See #8.

Summary

{0}------------------------------------------------

KI21318

Attachment 2

JUN - 6 2012

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

1. Submitter's Identification: Contact name: Melissa Lima PERMA LABORATORIES 120 Wakefield Run Blvd. Hinckley, OH 44233 Phone: 800-988-9194 Registration No.: 1528710
  Date Prepared: April 2, 2012
Name of the Device: ProSoft™ 2.
1. Common or Usual Name and Classification: OTC Denture Reliner Kit Common Name: Requlation: 21CFR Part 872.3560 Product Code: EBP

Predicate Device Information: 4. RELINE-IT was cleared under K101771. Tempo Tissue Conditional Reliner was cleared under K081514.

5. Device Description :

{1}------------------------------------------------

Once the impression has cured any excess material is trimmed with a sharp knife.

Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.

6. Intended Use

An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

Comparison to Predicate Devices: 7.

The ProSoft™ is substantially equivalent to the RELINE-IT in intended use, operation, safety and function.

The subject device is a self-curing reliner, whereas, the predicate device cures by placing the relined denture in hot water for 20 minutes. After following instructions for both relines the same results are achieved. Both devices form a soft, temporary denture base to relieve loose. irritating dentures resulting in substantial equivalence in regards to safety and effectiveness.

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Bench testing was performed to assess the functionality of the device as outlined in the FDA Guidance Document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits". Comparative testing data was provided for the RELINE-IT device. Testing was performed by a third party laboratory.

Supporting documentation to demonstrate biocompatibility was also supplied as part of the 510(k) submission.

Analysis of the data showed that the devices are substantially equivalent.

Discussion of Clinical Tests Performed: Clinical testing was not conducted.

{2}------------------------------------------------

10. Conclusions:

Based on the information provided in this submission we conclude that the ProSoft™ is substantially equivalent to the predicate and is safe and effective for its intended use.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

JUN - 6 2012

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

Perma Laboratories c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K121318

Trade/Device Name: ProSoft Denture Reliner Regulation Number: 21 CFR 872.3560 Regulation Name: OTC denture reliner Regulatory Class: II Product Code: EBP Dated: May 22, 2012 Received: May 23, 2012

Dear Mr. Job: -

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.

{4}------------------------------------------------

Page 2- Mr. Job

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

rol

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

1 Page of 1

510(k) Number (if known): K121318

Device Name: ProSoft Denture Reliner

Indications For Use:

An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR 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)

Susan Keane

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K421318

Regulation Number and Section

§ 872.3560 OTC denture reliner.

(a)
Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”