(194 days)
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
Uni-flex Resin is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
This document is a 510(k) clearance letter from the FDA for a dental resin product, Uni-Flex Resin. It's not a study report and therefore does not contain any information about acceptance criteria, device performance metrics, or study details.
The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use (producing a denture base in prosthetic partials).
Therefore, I cannot provide the requested information based on the given text.
If this were a study report, the typical structure for a response would look like this:
1. Table of Acceptance Criteria and Reported Device Performance
This would be extracted directly from a study results section, comparing a pre-defined performance target with the observed performance.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [e.g., Sensitivity] | [e.g., ≥ 90%] | [e.g., 92.5% (95% CI: 90.1-94.2%)] |
| [e.g., Specificity] | [e.g., ≥ 80%] | [e.g., 85.1% (95% CI: 83.0-87.1%)] |
| [e.g., AUC] | [e.g., ≥ 0.85] | [e.g., 0.88] |
2. Sample size used for the test set and the data provenance
This information would be found in the "Methods" or "Study Design" section.
- Test Set Sample Size: [e.g., 500 cases/images]
- Data Provenance: [e.g., Retrospective, collected from 3 hospitals in the USA and Canada]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This would also be in the "Methods" section, specifically detailing ground truth ascertainment.
- Number of Experts: [e.g., 3 independent experts]
- Qualifications: [e.g., Board-certified radiologists with an average of 15 years of experience in oncological imaging, specialized in breast MRI.]
4. Adjudication method for the test set
This would describe how disagreements among experts were resolved.
- Adjudication Method: [e.g., 2+1 (majority vote of initial two readers, with a third reader resolving disagreements), or Consensus meeting, or None (all experts had to agree)]
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 would be in a comparative study section.
- MRMC Study Conducted?: [e.g., Yes]
- Effect Size (Improvement with AI): [e.g., Human readers improved statistically significantly (p<0.001) from an average AUC of 0.78 without AI to 0.85 with AI assistance, a gain of 0.07 AUC points.]
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is common for initial performance evaluation.
- Standalone Study Conducted?: [e.g., Yes]
- Standalone Performance: [e.g., The algorithm achieved 93% sensitivity and 88% specificity in standalone mode on the test set.]
7. The type of ground truth used
Crucial for understanding the reliability of the ground truth.
- Type of Ground Truth: [e.g., Histopathology (biopsy-confirmed outcomes), Expert Consensus (majority decision of experienced clinicians), Clinical Outcomes (follow-up data and official diagnosis)]
8. The sample size for the training set
Relevant for understanding the data used to develop the AI model.
- Training Set Sample Size: [e.g., 10,000 images/cases]
9. How the ground truth for the training set was established
Similar to the test set, but for the training data.
- Ground Truth Establishment for Training Set: [e.g., Annotations by a team of 5 clinical residents, reviewed and corrected by a senior radiologist. For pathology-confirmed cases, direct pathology reports were used.]
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 a stylized caduceus or a representation of the human form, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1999
Ms. Caroline M. Zaleski Trans-Atlantic Dental 46 Arctic Parkway Trenton, New Jersey 08638
Re : K983461 Trade Name: Uni-Flex Resin Requlatory Class: II Product Code: EBI January 11, 1999 Dated: Received: January 14, 1999
Dear Ms. Zaleski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2 - Ms. Zaleski
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
Enclosure
{2}------------------------------------------------
Trans-Atlantic Dental 46 Arctic Parkway Trenton, NJ 08638 Tel/Fax (609) 695-0168 Indications for Use Statement
Device Name: Uni-Flex Resin
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
This material is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
Susan Purrer
Division Sign-Orf Division of Dental, Infection Cont and General Hospital Devic 510(k) Number
NOT A PRESCRIPTION
§ 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.