(35 days)
As orthodontic retainer
everStick™ ORTHO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ ORTHO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
The provided text is a 510(k) summary for the everStick™ ORTHO device, a glass fiber orthodontic retainer. It primarily focuses on demonstrating substantial equivalence to a predicate device (everStick™ K011788) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested fields cannot be directly extracted from this document as the information does not exist within the provided text. This device is a material, not an AI or diagnostic device that would typically have the kind of performance metrics you are asking for.
Here's an attempt to address the request based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
Based on the provided K021126 summary, there are no explicit acceptance criteria or reported device performance metrics in terms of sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI devices. The submission focuses on substantial equivalence to a predicate device (everStick™ K011788) based on material composition and intended use.
The key "performance" mentioned is that its composition is "equal with its predicate device, everStick™," with only "the ratio of glass fibers and polymer matrices are slightly different." It states that "everStick ORTHO does not expose the dentist nor the patient to unacceptable risks," which is a safety assertion rather than a performance metric.
| Metric/Criterion | Acceptance Criteria (Not stated as numerical values) | Reported Device Performance (Implied from equivalence) |
|---|---|---|
| Composition | Substantially equivalent to predicate device (everStick™ K011788) | "Equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different." |
| Safety | Does not expose to unacceptable risks. | "everStick ORTHO does not expose the dentist nor the patient to unacceptable risks." |
| Intended Use | For use as orthodontic retainer. | Met: Indication explicitly stated as "GLASS-FIBER REINFORCEMENT FOR ORTH-DONTIC RETAINERS". |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. A "test set" in the context of diagnostic device validation (especially AI) is not applicable here as this is a material rather than a diagnostic algorithm. The declaration of substantial equivalence often relies on existing data or literature for the predicate device, not new clinical studies with test sets in the same manner as AI.
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 applicable and not available. No "ground truth" establishment by experts for a test set is mentioned, as this is a material device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not available. No adjudication method is mentioned for a test set.
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
This information is not applicable and not available. This device is a material product, not an AI system. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available. This device is a material product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not available. The concept of "ground truth" in the context of diagnostic accuracy is not relevant for this material device submission. The "truth" here relates to material properties and safety, which are typically assessed through laboratory testing or existing literature on similar materials.
8. The sample size for the training set
This information is not applicable and not available. As this is not an AI/diagnostic device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not available. As there is no "training set," there is no ground truth established for it.
{0}------------------------------------------------
Koz n2le
510(k) Summary u
Stick Tech Ltd, PO Box 114, 20521 Turku, Finland Applicant: Tel: +358-2-4808 2558 Fax: +358-2-241 0032 Ilkka Kangasniemi, Ph.D. Contact Person: William M. Troetel, Ph.D. U.S. Agent to respond to 80 Parkway West FDA requests: Mount Vernon, NY 10552 Tel: (914) 664-1640 Fax: (914) 667-3993 wtroetel@westnet.com April 4, 2002 Date Prepared: everStick™ ORTHO Device Trade Name: Device Common Name: Glass fiber orthodontic retainer Denture relining, repairing, or rebasing resin Device Classificaton Name: (21 CFR §872.3760)
Description of Device:
everStick™ ORTHO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ ORTHO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
Intended Use: As orthodontic retainer
everStick™ ORTHO is substantially equivalent to everStick™, approved under 510(k) number K011788 dated November 7, 2001.
The composition of everStick™ ORTHO is equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different. The indication for use in orthodontics supplements the indications for use to be done with the predicate device.
{1}------------------------------------------------
By comparing the ingredients of everStick ORTHO to the existing data available from dental polymerizable material, it can be stated that everStick ORTHO does not expose the dentist nor the patient to unacceptable risks.
{2}------------------------------------------------
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism.
Public Health Service
MAY 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stick Tech. Limited C/O William M. Troetel, Ph.D., LLC 80 Parkway West Mount Vernon, New York 10552
Re: K021126
Trade/Device Name: everStick™ ORTHO Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and DYT Dated: April 05, 2002 Received: April 08, 2002
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 appeared were in 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 (1 ra )) var 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
{3}------------------------------------------------
Page 2 - Dr. William M. Troetel
You must comply with all the Act's requirements, including, but not limited to: registration r ou must compry was and many (21 CFR Part 801); good manufacturing practice and ilsung (21 CF R Part 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as bet rent in aroduct 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 1111s letter will and in yours of the FDA finding of substantial equivalence of your device to 910(x) promation nowledge 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 11 you debire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and catalians in onal (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" (21 CFR 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,
Valter Cussatfor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K021126 |
| Device Name: | EVER STICK ORTHO |
Indications for Use:
GLASS-FIBER REINFORCEMENT FOR
ORTH-DONTIC RETAINERS
(PLEASE DO NOT WRITE BFLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Runnes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.108) OR
Over the Counter Use _
§ 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.