The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary tecth by the temporalis muscle.

Device Description

Dental Concepts' Bite Plate is a soft, comfortable, custom-fit protector intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Dental Concepts Bite Plate, focusing on acceptance criteria, device performance, and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Dental Concepts Bite Plate) seeking clearance from the FDA. A 510(k) notification primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving that the new device meets specific, quantitative "acceptance criteria" through a comprehensive clinical study in the way a PMA (Pre-Market Approval) submission might. Therefore, the information typically found in a 510(k) differs significantly from what one would expect for a study proving device performance against detailed acceptance criteria using metrics like sensitivity, specificity, or AUC.

Based on the provided text, a conventional "study that proves the device meets the acceptance criteria" in terms of clinical efficacy metrics (like those used for AI/diagnostic devices) was not performed or reported in this 510(k) summary. The summary focuses on demonstrating substantial equivalence in terms of materials, intended use, and technological characteristics to a legally marketed predicate device.

Analysis of the Dental Concepts Bite Plate 510(k) Summary

Here's a breakdown of the requested information, acknowledging the limitations of a 510(k) summary for this type of query:

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

As explained above, this 510(k) does not present acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a clinical study designed to meet them. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device.

Acceptance Criterion (Implied for 510(k) clearance)	Reported Device Performance (from 510(k) Summary)
1. Intended Use Equivalence: The new device has the same intended use as the predicate device, or its differences do not raise new questions of safety and effectiveness.	Reported Performance: The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome. This is comparable to the general function of a jaw repositioning device/dental protector, as exemplified by the predicate Dr. Hays Bite Guard. The FDA's clearance letter confirms equivalence "for the indications for use stated in the enclosure."
2. Technological Characteristics Equivalence: The new device has the same technological characteristics as the predicate device, or differences in technology do not raise new questions of safety and effectiveness.	Reported Performance: - Both devices are intended to be custom-fit dental protectors. - Both are composed of thermoplastic resins that can be molded to fit the mouth. - The Bite Plate has a soft, formable clear upper material and a base material, both of thermoplastic resin, which can be molded when heated. The predicate, Dr. Hays Bite Guard, is composed of a single thermoplastic resin, also custom-fittable. - Minor dimensional differences are noted, but the Bite Plate can be trimmed for comfort. - Biocompatibility Assessment: A biocompatibility assessment was performed on the materials of the Bite Plate with satisfactory results, addressing a key safety aspect related to materials.
3. Safety & Effectiveness: The device is as safe and effective as the predicate device. For 510(k), this is demonstrated via substantial equivalence rather than independent clinical trials for efficacy.	Reported Performance: The FDA's clearance (MAR 26 2003 letter) states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the primary "proof" of meeting safety and effectiveness criteria in a 510(k) context. The biocompatibility assessment contributed to this finding. No clinical efficacy data directly comparing the new device against the predicate or a placebo is provided.

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

No "test set" in the context of a clinical performance study is described. The 510(k) summary does not report on a study involving a patient test set to evaluate the device's clinical performance. The assessment focuses on comparison to a predicate device.
The only "test" mentioned is a biocompatibility assessment of the materials. No sample size or data provenance details are given for this assessment in the summary, other than "satisfactory results."

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. As there was no clinical performance test set described, there were no experts used to establish ground truth in the context of evaluating diagnostic or treatment efficacy.

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

Not applicable. No clinical performance test set requiring adjudication was described.

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

Not applicable. This device is a physical dental protector/splint, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study for AI assistance is irrelevant to this submission.

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

Not applicable. This device is a physical dental protector. No algorithm or standalone performance evaluation was conducted.

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

Not applicable in the context of clinical performance evaluation. For the biocompatibility assessment, the "ground truth" would be established by standard toxicology and material science testing protocols according to relevant ISO/FDA guidance, with results interpreted against established safety thresholds.

8. The sample size for the training set

Not applicable. There was no "training set" as this is not an AI/machine learning device.

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

Not applicable. As above, no training set for an algorithm was involved.

Summary of Device Acceptance without Clinical Efficacy Study:

The Dental Concepts Bite Plate received 510(k) clearance by demonstrating substantial equivalence to an already legally marketed predicate device (Dr. Hays Bite Guard) regarding its intended use and technological characteristics, and by providing a satisfactory biocompatibility assessment. This type of submission relies on the established safety and effectiveness of the predicate device, rather than requiring new, extensive clinical efficacy trials for the new device itself. The FDA's letter is the "proof" that the device met the requirements for 510(k) clearance.

Summary

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K024261

MAR 2 6 2003

510(k) Summary for the Dental Concepts Bite Plate

SPONSOR 1.

Dental Concepts LLC 650 From Road Paramus, NJ 07652

Contact Person: Michael Lesser, President Telephone: (201) 225-2151

March 5, 2003 Date Prepared:

2. DEVICE NAME

None assigned at this time Proprietary Name: Common/Usual Name: Dental protector Classification Information:

Dental protectors have yet to be classified, but are proposed to be Class II devices, based on the recent classification of similar devices. Currently, predicate products are classified under the following classification name:

Name	Product Code	21 CFR Ref.	Panel
Jaw Repositioning Device	LQZ	872.5570	Dental

PREDICATE DEVICES 3.

Dr. Hays Bite Guard, 510(k) No. K014079, cleared February 22, 2002

DEVICE DESCRIPTION 4.

Dental Concepts Bite Plate Additional Information - K024261 March 13, 2003

Page B-1

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ಳು INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The Bite Plate is composed of a soft, formable clear upper material, made of a thermoplastic resin and a base material composed of a thermoplastic resin. When the product is heated and then cooled briefly, the upper material can be molded to fit to the upper teeth. The Dr. Hays Bite Guard is composed of a single thermoplastic resin that, like the Bite Plate, can be custom fit to the mouth. The products have slightly different dimensions, but the Bite Plate can be trimmed to fit the mouth more comfortably.

A biocompatibility assessment was performed on the materials of the Bite Plate with satisfactory results.

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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 stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2003

Dental Concepts LLC C/O Mr. Michael Lesser Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K024261

Trade/Device Name: Bite Plate Regulation Number: None Regulation Name: Dental Protector Regulatory Class: Unclassified Product Code: MQC Dated: March 5, 2003 Received: March 6, 2003

Dear Mr. Lesser:

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. Lesser

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 (OS) 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 (301) 594-4613. 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/cdrh/dsma/dsmamain.html

Sincerely vours,

Clus L
Susan Runner, DDS/MA

Interim 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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K024261

510(k) Number (if known): K024261

Bite Plate Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Reno

v. General Hospital.

510(k) Number. K024261

Dental Concepts Bite Plate Additional Information - K024261

科学学

March 13, 2003

CONFIDENTIAL Page A-1

Regulation Number and Section

N/A