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Anker II Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker II Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter (≥03.3mm) and short (length ≤ 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the maxillary lateral incisor or the mandibular central incisors.

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This document does not contain the information requested for acceptance criteria and the study proving a device meets those criteria.

The provided text is a 510(k) Premarket Notification from the FDA for a dental implant system (Anker II Dental Implant System). It states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

This type of FDA letter focuses on:

• Substantial Equivalence determination: This means the FDA believes the new device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) application.
• Regulatory information: It outlines the relevant regulations (e.g., general controls, manufacturing practices, labeling) that the device manufacturer must comply with.
• Indications for Use: It explicitly states what the device is intended for.

What is missing from this document for your request:

• Acceptance Criteria Table: There is no table defining specific performance metrics (e.g., accuracy, precision, strength, biocompatibility thresholds) that the device must meet.
• Reported Device Performance: No actual performance data from a study (e.g., tensile strength, fatigue testing results, clinical outcome data) is provided. The letter only refers to the device being "substantially equivalent."
• Study Design Information: There is no mention of:
  • Sample sizes for test sets or training sets.
  • Data provenance (country, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC studies, effect sizes, or even if an AI component is involved (this is a traditional dental implant, not an AI device).
  • Standalone performance.
  • Type of ground truth used or how it was established.

In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report or study describing performance against specific acceptance criteria.

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