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Legacy3 6mm Length consists of two-picce implants for one-stage on two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The Legacy3 6mm length implants consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.

The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work.

The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy.

The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.

The provided text describes a 510(k) submission for the "Legacy3 6mm Length Implants." This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. Therefore, the "acceptance criteria" are typically the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" refers to the non-clinical performance testing conducted to support this claim of substantial equivalence.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance testing, primarily mechanical and physical characterization, to demonstrate substantial equivalence.

• Sample Size for Test Set: Specific sample sizes for each mechanical test (static compression bending, fatigue, driving torque, screw torque) are not explicitly stated in the provided text. However, the testing was done for "worst-case devices," implying a selection of implants representing the range of sizes or configurations most likely to fail.
• Data Provenance: The data provenance is from laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, which is based in Calabasas Hills, CA, USA. This is an experimental/testing type of data. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the ground truth was established through non-clinical engineering and laboratory testing in accordance with recognized standards (FDA guidance, ISO 14801, ISO 11137-2, AAMI TIR-33). Ground truth in this context refers to the measured performance against established engineering benchmarks rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no human reader interpretation or clinical adjudication involved in the non-clinical performance testing. The "ground truth" was derived from direct physical and chemical measurements against defined engineering specifications and regulatory standards.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (dental implant), not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for the Legacy3 6mm Length Implants was based on:

• Engineering Specifications and Standardized Test Results: Compliance with established mechanical and physical performance benchmarks defined by FDA guidance ("Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (ISO 14801 for mechanical testing, ISO 11137-2 and AAMI TIR-33 for sterilization).
• Comparative Analysis: Demonstrating that the new device's performance (e.g., mechanical strength, surface area, pull-out strength) is equivalent to or better than that of already legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

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