(184 days)
Use for: Primosplint System should be used for producing functional therapy and bite splints.
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
This document is a 510(k) clearance letter from the FDA for the Primosplint System. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical device evaluations. The letter primarily establishes substantial equivalence to a legally marketed predicate device.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document does not describe specific performance characteristics, acceptance criteria, or a study that measures and reports these.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. There is no mention of a test set, sample size, or data provenance.
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)
- Information not provided. There is no mention of a test set or experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. No test set is 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
- Information not provided. This device is a "light composite developed for functional therapy bite splints," indicating it's a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information not provided and not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information not provided. No ground truth is discussed as no study is detailed.
8. The sample size for the training set
- Information not provided. No training set is discussed.
9. How the ground truth for the training set was established
- Information not provided. No training set or ground truth is discussed.
Summary from the provided document:
The document is a 510(k) clearance letter confirming that the Primosplint System is substantially equivalent to a legally marketed predicate device. The basis for clearance is not through a detailed performance study with acceptance criteria, but rather through demonstrating equivalence to existing devices. The key information provided about the device is:
- Trade/Device Name: Primosplint System
- Regulation Number: Unclassified
- Regulation Name: None
- Regulatory Class: None
- Product Code: MQC
- Indications for Use: Producing functional therapy and bite splints.
- Description of Device: A light composite developed for functional therapy bite splints and other applications. Fabricated outside of the mouth from stone models. May be polished mechanically or by the use of a glaze.
- Review Type: Section 510(k) premarket notification.
- Basis for Clearance: Substantial equivalence to legally marketed predicate devices.
- Confidential Chemical Analysis: Mentioned in "Rein Maly SachSR Appendix B," but the details are not included in this letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2003
Mr. Michael O` Malley President Cosmedent Company Incorporated 401 North Michigan Avenue Suite 2500 Chicago, Illinois 60611
Re: K030832
Trade/Device Name: Primosplint System Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: June 30, 2003 Received: July 1, 2003
Dear Mr. O' Malley:
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. O' Malley
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 (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), 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 yours,
Susan Kunnen
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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COSMEDENT®
INDICATIONS FOR USE STATEMENT
510(kK) Number (if known):
…
Device Name:
Primosplint System
Indication for Use:
Use for:
Primosplint System should be used for producing functional therapy and bite splints.
DESCRIPTION OF DEVICE
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
A confidential chemical analysis of Primosplint System may be found in Rein Maly SachSR Appendix B.
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K030832 |
|---|---|
| ---------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use
N/A