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Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.

RA-5 "ANESTO" is a handpiece, which, on the one hand, is provided with a coupling system according to ISO 3964. This coupling allows the handpiece's attachment onto a corresponding dental motor, for transmitting the motor's rotational movement to the attached intraosseous injection needle, intended to perforate cortical bone. On the other hand, it was designed for being equipped with an anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After having perforated the bone, this cartridge's anesthesia can be administered locally in the spongiosa by means of a manually-operated dosage lever. "ANESTO's" application is intended in dentistry.

The provided text describes the 510(k) summary for the "Handpiece RA-5 'ANESTO'" and its substantial equivalence determination. However, it explicitly states:

• "Clinical data were not needed for this new product."
• "Bench testing results demonstrate substantially equivalence."

This means that a formal clinical study with acceptance criteria, human readers, ground truth establishment, and training/test sets as typically understood for an AI/ML device was not conducted for this specific medical device submission. The substantial equivalence was based on bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, ground truth types, or training set details because this information is not present in the provided document.

Instead, the submission relies on the device being "substantially equivalent" to predicate devices based on:

• Intended Use: Drilling system to perforate cortical bone to administer local anesthesia in spongiosa; application in dentistry.
• Technological Characteristics: Similar to the predicate, but designed to be attached to and driven by a dental micro motor (air or electric motor) instead of an integrated air-supplied driving system. Handpiece shape and ease of operation were improved.
• Performance Parameter: Stated as "very similar to the predicate device."
• Material: Stated as "very similar to the predicate device."
• Performance Testing: Bench testing results were used to demonstrate substantial equivalence.

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