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"O" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

OCO Dental Implant (5.0 mm Diameter)

I am sorry, but based on the provided text, I cannot extract any information regarding acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document is an FDA 510(k) clearance letter for a dental implant (OCO Dental Implant, 5.0mm Diameter). It primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Clearance Determination: States that the device is "substantially equivalent" to legally marketed predicate devices.
• Regulatory Compliance: Outlines requirements for annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: Provides contacts for labeling regulations, promotion/advertising, and general responsibilities.
• Indications For Use: Briefly describes the intended use of the dental implant.

There is no mention of any specific study conducted by the manufacturer, acceptance criteria for performance, or any data to demonstrate the device meets such criteria. The FDA's substantial equivalence determination for this type of device (a Class III endosseous implant) typically relies on demonstrating that the new device has the same intended use, fundamental technological characteristics, and safety and effectiveness as a predicate device, often without requiring an entirely new clinical study with performance metrics in a 510(k) submission.

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"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.

OCO Dental Implant (3.25mm diameter)

I apologize, but the provided text from the FDA 510(k) summary for the "OCO Dental Implant" does not contain information about acceptance criteria, device performance metrics, or details of a study involving AI or human readers.

The document is a traditional 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device for its stated indications for use. It primarily focuses on regulatory compliance and does not include the type of performance study data that would be relevant to AI-based medical devices or even detailed clinical performance data for traditional devices beyond what is necessary to establish substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

Ask a specific question about this device

Ask a specific question about this device