(510 days)
MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device named "Morpheus," which is a cartridge syringe intended for anesthetic applications in dentistry. This document does not describe any acceptance criteria or a study that proves the device meets specific performance criteria.
The information typically requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is related to the evaluation of AI/ML or diagnostic devices. The "Morpheus" device, as described, is a cartridge syringe, which is a mechanical device, not a diagnostic or AI-powered one. Therefore, the type of performance evaluation and acceptance criteria for such a device would focus on aspects like materials biocompatibility, sterility, dimensions, force required for delivery, leakage, and other physical/mechanical properties, rather than diagnostic accuracy metrics.
The FDA letter essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This determination is based on the information provided in the 510(k) submission, which would include testing results relevant to the device's function as a cartridge syringe, but these specific details are not present in the provided FDA letter.
Therefore, I cannot provide the requested information based on the given input. The document does not contain the study details, acceptance criteria, or performance metrics typically associated with the evaluation of AI or diagnostic devices.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.