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For immediate or delayed surgical placement of a Dental implant in the anterior region and to allow immediate restoration (for cosmetic purposes).

The Reliadent Dental Implant System includes surgical implants, healing cap, restoration abutments, and surgical instruments.

Implants: Includes one or two step dental implant devices which are designed as conical and cylindrical shapes. They consist of various diameters with a range of 3.6mm-6.0mm and lengths with a range of 8mm-21mm. The internal and external hexagonal shapes are important to maintain the implant stability. One group of the products is HA coated. This surface has been modified to enhance the osseointegration. The dental implants are composed of medical grade 4 pure titanium.

Cover screw and healing cap: The cover screw and healing caps are supplied together with the implants. They cover the internal body of implant to allow gum free space for connection between the implants and restoration abutments.

Abutment: Abutments and accessories are the support part to prosthetic restoration. Screw retained abutments are included in the Reliadent Dental Implant System. The abutments are composed of medical grade 2 titanium.

Surgical Instrument Kit: The surgical instruments include the implants installation set, abutment connections, and drill set. There are hand tools, drill bits of different sizes, and handles in these sets. The instrument kit is designed to be used with a wide range of commercially available implant devices.

This document is a 510(k) summary for the Reliadent Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not present in the provided text.

Here's an analysis of what can be extracted and what is missing:

The provided text does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or technical performance study would for a novel device. Instead, it demonstrates substantial equivalence to an already cleared predicate device (MIS Dental Implant System, K040807). This is a common pathway for device clearance, where the new device is shown to have the same intended use, similar technological characteristics, and equivalent performance to a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, reported device performance metrics (like sensitivity, specificity, accuracy, etc.), sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone performance is not applicable in the context of this 510(k) submission, as these types of studies were not presented or required for this type of submission.

Here's a breakdown based on your request, highlighting what's available and what's explicitly missing/not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided. No specific test set or clinical study data proving performance for the Reliadent Dental Implant System were presented in this 510(k) summary. The submission relies on demonstrating similarity to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. No test set requiring expert-established ground truth was detailed in this substantial equivalence submission.

4. Adjudication method for the test set

• Not applicable / Not provided. No test set requiring adjudication was detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not done. This device is a dental implant system, not an AI-powered diagnostic tool. MRMC studies are irrelevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable / Not done. This device is a physical medical device (dental implant), not an algorithm or software. Standalone performance studies in this context typically refer to AI algorithms, which is not relevant here.

7. The type of ground truth used

• Not applicable / Not provided. As no performance study with a test set was detailed, no ground truth was established within this submission. The "truth" here is the prior clearance and presumed safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable / Not provided. No training set was used. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable / Not provided. No training set or associated ground truth was established.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence to a predicate device (MIS Dental Implant System, K040807). The argument for meeting the "acceptance criteria" (which is primarily substantial equivalence) is made by:

• Comparing Intended Use: The Reliadent system has the "same intended use" as the MIS Dental Implant System.
• Comparing Materials: Both devices use medical grade titanium. The Reliadent system specifies medical grade 4 pure titanium for implants and medical grade 2 titanium for abutments.
• Comparing Design: The Reliadent system includes "similar" surgical implants, healing caps, restoration abutments, and surgical instruments, with conical and cylindrical shapes, various diameters and lengths, and internal/external hexagonal shapes. A key difference mentioned is the "modified surface" (HA coated) on one group of products in the Reliadent system, intended to "enhance osseointegration." However, this is presented as an enhancement rather than a deviation requiring explicit comparative performance data with the predicate.
• Concluding Equivalence in Performance and Safety: The submission states, "All other technological characteristics are similar and both devices show equivalent performance capabilities," and that the Reliadent system "does not raise any additional concerns regarding safety and effectivity."

The FDA's letter (K061323) confirms their review of the submission and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications for Use" section further clarifies the specific use recognized by the FDA for the RDI Dental Implant System.

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