(52 days)
The TWISTT.M. (Recioprocating Disposable Prophy Angle) is indicated for teeth cleaning/ polishing.
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
This is a 510(k) clearance letter for a medical device called the "Twist Reciprocating Disposable Prophy Angle." This document primarily deals with regulatory approval based on substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of regulatory document.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The letter states that the FDA "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." This implies that the 'acceptance criteria' were met through a demonstration of substantial equivalence to a legally marketed predicate device, rather than through specific performance metrics outlined in this letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. 510(k) summaries might sometimes contain summaries of performance data, but this specific clearance letter does not.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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/provided in the document. The device is a "Reciprocating Disposable Prophy Angle" which is a dental instrument, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided in the document. This device is a physical dental instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. For a physical device like this, performance testing might involve mechanical durability tests, biocompatibility tests, or efficacy studies for teeth cleaning/polishing, but the details of such tests or their 'ground truth' are not in this letter.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
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Image /page/0/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 stripes forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Robert T. Postal Vice President Medidenta International, Incorporated 39-23 62nd Street Woodside, New York 11377
OCT - 9 1997
K973062 Re : Twist Reciprocating Disposable Prophy Angle Trade Name: Requlatory Class: I Product Code: EFA Dated: Auqust 12, 1997 Received: August 18, 1997
Dear Mr. Postal:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Postal
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Clifford
Timo IV A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
. Enclosure
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510(k) Number (if known): ___K973062
Device Name: _ TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
Indications for Use:
The TWISTT.M. (Recioprocating Disposable Prophy Angle) is indicated for teeth cleaning/ polishing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swar Rurrel
(Division Sign-C Division of Dental, and General Hot 510(k) Numbe
Prescription Use: ﺳﺎ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use:_________________________________________________________________________________________________________________________________________________________
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.