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The AB Dental Devices implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions.

The provided document K112440 is a 510(k) premarket notification for AB Dental Devices Implants and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly proving safety and effectiveness through clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain explicit "acceptance criteria" in the sense of performance metrics with specific thresholds that were met by a study. Instead, the "acceptance" by the FDA is based on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, there are no explicit acceptance criteria and corresponding reported device performance metrics in the format typically seen with clinical efficacy studies. The "performance" is demonstrated through comparison to predicates and non-clinical tests.

The document highlights the following non-clinical tests performed on the AB Dental implants:

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document mentions "a selected number of its dental implants" for fatigue testing.
• Data Provenance: The testing was conducted by AB Dental Devices Ltd., an Israeli company. The data is thus of Israeli origin. The studies are non-clinical (laboratory/bench testing).

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

This concept is not applicable as this is a 510(k) submission for substantial equivalence based on non-clinical testing, not a study requiring expert-established ground truth for a diagnostic device. The "ground truth" here is compliance with established engineering standards and comparison to predicate devices, which is assessed by the FDA reviewers.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the sense of a clinical or observational study requiring adjudication of findings.

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

No. This is a 510(k) submission for dental implants and accessories, not a diagnostic imaging device. An MRMC study is not relevant to this type of device and submission.

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

Not applicable. This device is a physical dental implant and accessories, not a software algorithm or AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Existing International Standards: Compliance with ISO 14801 for dynamic fatigue testing.
• Comparison to Predicate Devices: Demonstrating that the new devices have similar technological characteristics, indications for use, and performance to already legally marketed devices.
• Non-Clinical Test Results: The measured pullout strength, surface characteristics, and fatigue performance are the "truth" for the device's physical properties.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable, as there is no training set for this device.

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