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The 3i Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The 3i Locator Abutment System consists of a titanium alloy socket that is attached to a dental implant having an internal threaded socket. Both devices have a nylon component that has a shape on one end that mates into the socket. The other end of the nylon component is attached to the denture. This arrangement provides snap-fit retention of the denture. The system is identical to the predicate devices, except for a modification to allow use with 3i's Osseotite implant, and a modification of the system prior to distribution by 3i.

This document describes modifications to the "3i Locator Abutment System," which is a component of a dental implant system. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the "acceptance criteria" and "device performance" are framed in terms of demonstrating equivalence to the predicate device, the "Zest Locator® Anchor System."

Here's an analysis of the provided information, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "Sterilized Nylon 101 components (replacement males)" were fatigue tested in 2001, but does not specify the sample size used for this particular test set.
• Data Provenance: The testing appears to be retrospective in the sense that it relies on "previously submitted bench testing" for the predicate device and internal testing done by the company (or a contracted lab) for the modified components. The country of origin is not explicitly stated, but given it's an FDA submission, the testing would generally need to adhere to US regulatory standards.

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

This type of information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence here is based on engineering principles and objective physical measurements (retention, occlusal forces, fatigue strength), not on expert clinical interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments where discrepancies need to be resolved. This submission relies on objective bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on reader performance. This submission is for a mechanical dental device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The performance data presented is "standalone" in the sense that it's the device's inherent mechanical performance measured through bench testing, not influenced by human interaction or interpretation beyond setting up the test. There is no "algorithm" in the AI sense; rather, it's the physical device's mechanical performance.

7. The Type of Ground Truth Used

The ground truth used is primarily engineering specifications and benchmarked mechanical performance. Specifically:

• Established effectiveness in retention and withstanding occlusal forces, as demonstrated by the predicate device's prior testing.
• A specific fatigue strength threshold (at least 175 pounds after 5 million cycles).
• Equivalence in performance between sterilized and non-sterilized components.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

Not Applicable. As there is no training set, this point is not relevant.

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