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The TRU Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The TRU Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The TRU Implant System is only intended for use with straight abutments. The TRU implant body is intended to be placed such no angle correction is necessary.

The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube. A special driver is available for the implants which simplant insertion by eliminating the need for an implant mount.

The proposed TRU Dental Implant will be available in a range of lengths and diameters.

The prosthetic components for the TRU implant System include Healing abutments, Straight Abutments and UCLA Abutments.

This report summarizes the acceptance criteria and study information for the TRU Dental Implant System based on the provided FDA 510(k) summary (K150968).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of quantitative acceptance criteria or specific device performance metrics in numerical form. Instead, the substantial equivalence determination relies on comparison of technological characteristics and confirmation of appropriate performance through non-clinical testing.

The "Performance Testing" section states: "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use."

Therefore, the acceptance criteria implicitly derived are that the device's technological characteristics and performance meet or are substantially equivalent to the predicate devices and the relevant FDA guidance document for root-form endosseous dental implants.

Table of Implicit Acceptance Criteria and Reported Device "Performance" (via Equivalence)

Study Details

The provided document describes a non-clinical study to demonstrate substantial equivalence, rather than a clinical trial with patient outcomes.

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical testing, which typically does not involve human subjects or a "test set" in the sense of patient data.
   • The "test set" implicitly refers to the specific configurations and types of implants and abutments manufactured for performance testing, as detailed in the product description (e.g., various diameters and lengths).
   • Data Provenance: Not applicable in the context of human data. The testing refers to laboratory-based, non-clinical evaluations.

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

   • Not applicable. This was a non-clinical, laboratory-based study for demonstrating device performance and equivalence against established standards and predicate devices. No human 'ground truth' experts were involved in evaluating test outcomes in the way they would be for diagnostic accuracy studies. The "ground truth" here is compliance with engineering and material standards and performance comparable to established predicate devices.

3. Adjudication method for the test set:

   • Not applicable. As a non-clinical performance study, there's no "adjudication" in the sense of reconciling disagreements among human readers or evaluators. The results would be objectively measured physical properties and performance characteristics.

4. 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:

   • No. This is a medical device for implantation, not an AI/diagnostic software. No MRMC study was performed.

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

   • No. This is a medical device, not an algorithm or AI. The performance testing is inherent to the physical device.

6. The type of ground truth used:

   • The "ground truth" for this substantial equivalence determination is conformance to recognized standards, engineering specifications, and established safe and effective performance of the predicate devices.
   • This includes:
     • Compliance with 21 CFR 872.3640 (Endosseous Dental Implant regulation)
     • Adherence to "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
     • Demonstrated equivalence of technological characteristics (material, design, dimensions, surface treatment, intended use, etc.) to the identified predicate devices (Nobel Active Internal Connection Implant (K071370) and Sterngold Acid Etch Dental Implant System (K023580)).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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