(63 days)
Variflex™ is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
This is a 510(k) premarket notification for a dental material (Variflex™ heat-softening acrylic), not a medical device software or AI algorithm. Therefore, many of the requested criteria such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable.
Here's the information gleaned from the document regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria (Implicit) | Reported Device Performance (Variflex™) | Predicate Device (Clearsplint™) |
|---|---|---|---|---|
| Technological Characteristics | Mechanical properties | Performance comparable to predicate device for indicated use. | Not explicitly stated, but implied to be sufficient for indicated use. | Not explicitly stated. |
| Hardness | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Water absorption | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Discoloration | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Physical properties variation with temperature | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Biocompatibility | MEM Elution Test | Non-cytotoxic | Non-cytotoxic | Not explicitly stated for predicate in this document. |
| Mucous membrane irritation | Non-irritant | Non-irritant | Not explicitly stated for predicate in this document. | |
| Kligman Maximization Test (NaCI) | Non-sensitizer | Non-sensitizer | Not explicitly stated for predicate in this document. |
Note: The document states that "We conclude that the similarity in composition between Variflex™ and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Variflex™ for the indicated uses." This implies that the acceptance criteria for the mechanical and physical properties were met if they were comparable or equivalent in performance to the predicate device, as the 510(k) process is about demonstrating substantial equivalence. Exact numerical acceptance criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text for any of the tests (mechanical, physical, or biocompatibility).
- Data Provenance: Not specified. It's standard for such tests to be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material testing for a physical device, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. No "adjudication" in the sense of expert consensus on interpretations is relevant here. The tests are objective laboratory measurements.
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 material test, not a diagnostic imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material test.
7. The type of ground truth used
For the biocompatibility tests (MEM Elution Test, Mucous membrane irritation, Kligman Maximization Test), the "ground truth" is established by standard biological assays and their predefined thresholds for cytotoxicity, irritation, and sensitization. For the mechanical and physical properties, the "ground truth" would be the standard measurement techniques and reference values for similar dental materials, with the predicate device serving as a comparative benchmark.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
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Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo features a black and white image of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a circular fashion above the image, and the word "ORTHODONTICS" is written in a circular fashion below the image.
JAN 2 1 2004
Great Lakes Orthodontics, LTD.
An Employee Owned Company
Our Vision "Delight our customers. Respect and help our co-workers."
510(k) SUMMARY
CONTACT PERSON: Mr. Mark Lauren Great Lakes Orthodontics 800-828-7626 mlauren(a)greatlakesortho.com
DATE PREPARED: November 10, 2003
TRADE OR PROPRIETARY NAME: Variflex™ COMMON NAME: Dental acrylic, heat-softening acrylic CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872,3760 Product Code: EBI
PREDICATE DEVICE:
Clearsplint™ Astron Dental Corporation 815 Oakwood Road Unit G Lake Zurich, IL 60047 800-323-4144
DEVICE DESCRIPTION
Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
INTENDED USE
Variflex " is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE Variflex™ was evaluated as follows:
Mechanical properties, Hardness, Water absorption, Discoloration Variation of physical properties with temperature
Variflex™ was also evaluated as follows: MEM Elution Test
non-cytotoxic Mucous membrane irritation non-irritant Kligman Maximization Test (NaCI) non-sensitizer
We conclude that the similarity in composition between Variflex " and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Variflex™ for the indicated uses.
200 Cooper Avenue • P.O. Box 5111 • Tonawanda, New York 14151-5111 716-871-1161 · · 800-828-7626 · · · Fax (716) 871-0550 e-mail: info@greatlakesortho.com · · Website: www.greatlakesortho.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. Mark Lauren Director of Research Great Lakes Orthodontics, Ltd. 200 Cooper Avenue Tonawanda, New York 14151-511
Re: K033632
Trade/Device Name: Variflex™ Heat Softening Acrylic Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 17, 2003 Received: December 01, 2003
Dear Mr. Lauren:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enerosure/ to regary than of the Medical Device Amendments, or to devices that prior to May 26, 1770, the chactions and the provisions of the Federal Food, Drug, and Cosmetic liave been reclassince in accordance wof a premarket approval application (PMA). You may, ACt (Act) that do not require apple far the general controls provisions of the Act. The general therefore, mance the device, babyest er an irements for annual registration, listing of devices, good Controls provisions of clibeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classifica (see ao ro) into existing major regulations affecting your device can be may be subject to such additional volta of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 – Mr. Mark Lauren
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 premated 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 in you don't openite 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, and as reflecting or and mentitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may 1 at to in of 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,
Carl
Chiu S. Lin. PhD 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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Indications for Use
510(k) Number (if known): K033632
Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150
Device Name: Variflex™ heat softening acrylic
Indications for Use:
Variflex™ is intended for the laboratory fabrication of dental appliances such as splints and night guards.
Prescription Use (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033632
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§ 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.