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

The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

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The provided document is an FDA 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed clinical study report addressing performance metrics.

Therefore, I cannot provide the requested information based on the given text.

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The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The Locator Implant Anchor is an abutment for endosseous implants.

Here's an analysis of the provided text regarding the Locator Implant Anchor, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Removal Retention Force: The sample size is not explicitly stated. It mentions "Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor," implying that multiple measurements were taken for each device, but the number of devices or measurements is not provided.
• Fatigue Strength: The sample size for fatigue testing is not explicitly stated. It refers to "the Angle Correction Base," indicating a specific component was tested.
• Data Provenance: Not specified. The document does not indicate the country of origin or whether the data was retrospective or prospective.

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

• This information is not applicable to this submission. The device is a physical medical device (implant abutment), and the testing described involves objective physical measurements (retention force, fatigue strength) rather than subjective expert assessment of data like images or patient outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable. As a physical device with objective measurements, there is no need for expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This information is not applicable. The device is an implant abutment, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable. The device is a physical implant abutment and does not involve an algorithm.

7. The Type of Ground Truth Used

• The ground truth for the performance testing is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.
  • For removal retention force, the ground truth is the direct measurement of force required to remove the anchor.
  • For fatigue strength, the ground truth is the direct measurement of the force sustained after a specified number of cycles.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The comparison is made against a predicate device.

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

• This information is not applicable as there is no training set for this device.

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