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This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors.
Prescription Use: Used by dental Professional Only
Over the Counter Use: No

DPA Attachment Twist/Flex Adapter

I am sorry but this document is a 510(k) clearance letter from the FDA for a dental device (DPA Attachment Twist/Flex Adapter). It primarily addresses the regulatory approval process and includes an "Indications for Use" statement.

I am unable to find the requested information in the document provided, in particular there is no mention of:

1. Acceptance criteria or device performance results.
2. Details on sample sizes, data provenance, or ground truth establishment for any studies.
3. Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
4. An effect size of how much human readers improve with AI vs without AI assistance.

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This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.

Disposable Prophy Angle

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device called "Disposable Prophy Angle Project's 020,021." This letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

The letter explicitly states that the FDA's issuance of a substantial equivalence determination "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It focuses on regulatory compliance rather than performance data or study results.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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