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510(k) Data Aggregation
(366 days)
The Ritter Dental Implant System is intended to replace one or more missing teeth in the upper or lower to restore the patient's chewing function. The abutments are used with implants to support a prosthetic device in a partially or edentulous patients. The Ritter Dental Implant System is intended to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
The Ritter Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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This document is a 510(k) clearance letter for the Ritter Dental Implant System, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices but does not provide information about acceptance criteria or specific studies proving the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.
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(299 days)
The Ritter Dental Implant System is intended to replace one or more missing teeth in the upper or lower jaw in order to restore a patient's chewing function. The abutments are used with endosseous dental implants to support a prosthetic device in a partially or edentulous patients. The Ritter Dental Implant System is intended to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
The Ritter Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Not Found
This document is a 510(k) clearance letter for the Ritter Dental Implant System. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.
The provided text pertains to regulatory clearance for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the questions related to AI/ML device performance, ground truth, sample sizes for training/testing, expert adjudication, or MRMC studies are not applicable to this document.
To answer your request, I would need a document related to an AI/ML medical device.
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