As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances. As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges. As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.

Device Description

everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase the strength and stiffness of the final product perpendicular to the direction of the fibers.

AI/ML Overview

This submission describes the "everStick™" device, a glass fiber reinforcement material for dental applications. However, the provided text does not contain a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics.

Instead, the submission is a 510(k) premarket notification for substantial equivalence, where the new device (everStick™) is compared to a predicate device (fibreStick™, K003333). The core of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed predecessor, not necessarily to set and meet new performance benchmarks through a dedicated clinical study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
Reported Device Performance:
- "Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics."
- "everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber."
- "The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device."
- "Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device."
Note: While tests were performed, the specific results (e.g., tensile strength, bond strength, flexural modulus, etc.) and their comparison to specific numerical acceptance criteria are not provided in this summary. The "performance" is primarily described in terms of its equivalence to the predicate and the absence of new safety concerns.

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Substantially equivalent to predicate device (fibreStick™) in safety and effectiveness.	"device is as safe and effective as the predicate device."
No new questions of safety and effectiveness raised by technological differences.	"The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness."
No new hazards presented compared to predicate device.	"Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device."

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

Sample Size: Not specified. This document only mentions "testing" and "test results" without detailing the number of samples or specimens used in any specific test.
Data Provenance: Not specified. The country of origin of the testing data is not mentioned. Given the applicant is from Finland, it's possible testing occurred there. The nature (retrospective/prospective) of the data collection is also not specified, though typically engineering or bench testing is prospective for a new device.

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 type of information is generally relevant for studies involving human interpretation or clinical endpoints that require expert assessment to establish ground truth (e.g., image-based diagnostic devices). This submission is for a material used in dentistry, and the evaluation relies on physical/mechanical testing, not expert consensus on diagnostic interpretations.

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

Not Applicable. As above, adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant for the type of testing implied for this dental material.

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 is a dental material, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI improvement effect sizes are not relevant.

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

Not Applicable. This is not an algorithm or AI device.

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

Ground Truth: The "ground truth" in this context would likely be established through standard engineering and materials science methods. For example, a universal testing machine would measure material properties (e.g., flexural strength, modulus) which are considered objective physical properties, not subject to expert interpretation for ground truth. Comparison would be made to the predicate device's known properties or established industry standards for dental materials.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

Not Applicable. As above, no training set for AI.

Summary

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NOV 0 5 2001

510(k) Summary E.

Applicant:	Stick Tech Ltd, PO Box 114, 20521 Turku, FinlandTel: +358-2-4808 2558Fax: +358-2-241 0032
Contact Person:	Ilkka Kangasniemi, Ph.D.
U.S. Agent to respond toFDA requests:	William M. Troetel, Ph.D.80 Parkway WestMount Vernon, NY 10552Tel: (914) 664-1640Fax: (914) 667-3993wtroetel@westnet.com
Date Prepared:	June 4th, 2001
Device Trade Name:	everStickTM
Device Common Name:	Glass fiber reinforcement material
Device Classification Name:	Denture relining, repairing, or rebasing resin(21 CFR §872.3760)

Description of Device:

Intended Use:

As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances.

As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges.

As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.

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everStick™ is substantially equivalent to fibreStick™, approved under 510(k) number K003333 dated January 4, 2001.

Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics.

everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber. The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device.

Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device.

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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 features a stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 5 2001

Stick Tech Limited C/O Dr. William Troetel Managing Partner William M Troetel, LLC 80 Parkway West Mount Vernon, New York 10552

Re: K011788

Trade/Device Name: Everstick Regulation Number: 872.3760 Regulation Name: EBI Resin, Denture, Relining, Pepairing, Rebasing Regulatory Class: II Product Code: EBI Dated: October 29, 2001 Received: October 30, 2001

Dear Dr. Troetel:

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.

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

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Page 2 - Dr. Troetel

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Fet of all - 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 insting (21 es read of 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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NOV 0 5 2001

B-1

B. Indications for Use

510(k) Number (if known): KOLL788

Device Name: __everStick™

Indications for Use:

As reinforcement in manufacturing and/or repairing full or partial dentures as ● well as overdentures and orthodontic appliances.
As reinforcement for temporary and/or permanent plastic/composite inlays, . onlays and bridges.
As reinforcement for customized splints used to immobilize teeth which may . be required post-trauma, post-operative, or for orthodontic therapy.

Susan Punney

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)

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.