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The ZoomCam LD-10 Intraoral Camera and Accessories are indicated for use to provide a image of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as the results.

ZoomCam LD-10 Intraoral Camera and Accessories

This document is a 510(k) clearance letter from the FDA for the ZoomCam LD-10 Intraoral Camera. It primarily focuses on the regulatory approval and does not contain the detailed study information needed to answer the prompt.

Specifically, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was found substantially equivalent to a predicate device, which often implies that extensive new clinical studies to establish acceptance criteria/performance from scratch were not required or performed for this specific submission. The focus of the 510(k) process is typically on demonstrating equivalency to existing devices, rather than proving novel performance metrics through extensive trials.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided FDA clearance letter.

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THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.

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The provided document is a 510(k) clearance letter from the FDA for the Elegance MS-10 (25k) Ultrasonic Scaler. It does not contain information about acceptance criteria, specific study designs, or performance data for a device meeting acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a study demonstrating it met specific acceptance criteria. A 510(k) submission typically includes a comparison to a legally marketed predicate device, addressing aspects like technological characteristics and performance, but it often does not involve the kind of detailed clinical study with acceptance criteria, ground truth, and expert evaluation described in your request for AI/medical imaging devices.

Therefore, I cannot provide the requested information from this document. The document confirms the device's clearance for marketing and its intended use, but it does not detail the specific performance metrics or studies you are asking for.

Ask a specific question about this device