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The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.

The Enhance Dental Implant System (Enhance System) is a system of threaded root-form dental implants and abutments.

This document, K061335, describes the 510(k) premarket notification for the Coastal Biocare Enhance Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for a new device's efficacy or safety.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not applicable or cannot be extracted from this document. The document primarily functions as a regulatory submission outlining the device's characteristics and its equivalence to already marketed devices.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This document does not specify performance-based acceptance criteria for the Enhance Dental Implant System itself, nor does it present a study that reports device performance against such criteria. The 510(k) process for this type of device relies on demonstrating substantial equivalence to predicate devices. The "criteria" are met by showing similar intended use, design, materials, and functional characteristics to devices already cleared by the FDA.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. No specific "test set" in the context of clinical performance evaluation is mentioned. The submission is a regulatory filing, not a clinical study report.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. There is no mention of a test set or ground truth established by experts in this document.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no mention of a test set or adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document does not describe an MRMC comparative effectiveness study. The focus is on device characteristics and regulatory equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical dental implant system, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Not Applicable. No ground truth, in the context of clinical or performance data, is mentioned or used in this submission. The "truth" for this submission is regulatory equivalence to predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no mention of a "training set" in the context of a study for this device.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. There is no mention of a "training set" or its ground truth.

Summary of Information Present in the Document:

While the document doesn't fit the requested structure for a performance study, it does contain important information relevant to the device:

• Device Name: Enhance Dental Implant System
• Intended Use: "The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing."
• Device Description: Threaded root-form dental implants with a finely grooved tapered collar, made of commercially pure titanium, with internal hex. Includes straight abutments, cover screws, and a retainer screw.
• Materials: Implants made of CP titanium Grade 4 (ASTM F 67), abutments of Ti-6Al-4V ELI alloy (ASTM F136).
• Sterilization: Co6 gamma irradiation at 25 kGy (2.5 Mrad) for implants; other components provided non-sterile.
• Equivalence to Marketed Device: The submission states that the Enhance Dental Implant System is substantially equivalent in indications and design principles to predicate devices. This means that its intended use, design, materials, and functional characteristics are substantially the same as devices already cleared by the FDA.

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