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IMCOR implants are indicated to replace missing tooth roots for single tooth, partial and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process. The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace. All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.

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The provided document is a 510(k) premarket notification approval letter for the IMCOR™ HA Coated Dental Implants. This type of document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not a review of clinical efficacy or performance studies with detailed acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this document.

The document only states the indications for use of the IMCOR™ implants, which are:

• To replace missing tooth roots for single tooth, partial, and fully edentulous patients.
• The cover screw is used to protect the top of the implant and internal threads during healing.
• The system is designed to become an osseointegrated prosthesis allowing attachment of prosthodontic appliances.

The FDA's finding of substantial equivalence means they determined that the IMCOR™ device is as safe and effective as a predicate device already on the market, based on the information submitted by the manufacturer. This typically involves comparing features, materials, and intended use, not necessarily providing a new, independent performance study with defined acceptance criteria in the approval letter itself.

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