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Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.

The Jet-Mate™ Sterilizable Handpiece is a detachable dental handpiece. It is designed to be detached from the cable assembly for the purpose of autoclave sterilization. This modified handpiece is used with the Cavitron® dental units.

The provided text describes a 510(k) premarket notification for a dental device, the "Jet-Mate™ Sterilizable Handpiece." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with detailed performance metrics against acceptance criteria.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Here's why and what the document does indicate:

• Substantial Equivalence: The core of a 510(k) submission is to show that the new device is "substantially equivalent" to a predicate device. This often means demonstrating similar technological characteristics, intended use, and safety/effectiveness without necessarily conducting new clinical trials that establish performance against novel acceptance criteria.

• Predicate Device: The Jet-Mate™ Sterilizable Handpiece is found to be substantially equivalent to the "Steri-Mate™ Handpiece (K941392)."

• Rationale for Equivalence: The document states: "The Jet-Mate™ Sterilizable Handpiece has the same principles of operation and is very similar in design characteristics to the marketed device." It also mentions, "Because of the nearly equivalent material composition of JET-MATE™ STERILIZABLE HANDPIECE to the predicate device, no additional toxicity testing was necessary."

• Intended Use: The intended use of the Jet-Mate™ is "for general prophylaxis treatments to remove calculus, plaque and stains from teeth," which is stated to be the "same intended use as previously cleared for K941392, Steri-Mate™ Handpiece."

In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a device that has already established its safety and effectiveness. There is no new study described in this document that would provide the detailed information requested in your prompt.

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