(100 days)
The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.
The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.
The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.
The provided text is a 510(k) summary for the FixaFloss device, a waxed dental floss with a silicone conical clamping element intended for rubber dam fixation. However, it does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device (The Hygenic Corp., Wedjets). It describes the device, its intended use, and claims substantial equivalence, but it does not present:
- A table of acceptance criteria.
- Reported device performance against specific criteria.
- Details of any study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth).
- Information on training sets.
Therefore, I cannot fulfill your request based on the provided text. The document's purpose is to clear the device for market by showing it is similar to an existing product, not to publish detailed performance study results against specific criteria.
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.