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A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

A.B. DENTAL DEVICES® Dental Implants System consists of narrow (XXX-3 model number) and standard (XXX-3.75 model number) platform internal hex implants that are used with screw retained, cement retained, or overdenture abutments. This submission adds the following abutments:

• Expansion of the P4 angled abutments to include: .
  • Narrow platform abutments (standard and long lengths, 15 and 25 degrees) o
  • Narrow platform, anatomic abutments (15 degrees) o
  • o Additional standard platform abutments (15 and 25 degrees)
  • Additional standard platform, anatomic abutments (15 and 25 degrees) O
• . Expansion of the P5 ball attachments to include narrow platform, 20 degree abutments
• Expansion of the P14 multiunit, angled abutments to include:
  • Additional sleeve materials (Delrin and CoCr) O
  • Narrow platform abutments (17 and 30 degrees) O
  • P25 AB LOC for angular adaptor O
• Addition of P64 multiunit, straight and angled product line (narrow and standard platform, 17 ● and 30 degrees, with Delrin and Ti alloy sleeves), including its healing cap.
• . Modification to the P4a-S screw to improve its performance characteristics

The provided document is a 510(k) summary for the A.B. DENTAL DEVICES® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on the expansion of existing abutment lines and the addition of new ones. The document details the performance testing conducted to demonstrate substantial equivalence, primarily bench testing for mechanical properties and rationale for other characteristics.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the manner typically seen for algorithmic performance. Instead, it describes various tests and states that the differences in the subject device do not raise new issues or are addressed through testing to establish substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly meeting the performance of the predicate devices or demonstrating that the modifications do not create a new worst-case scenario.

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

The document states that "worst-case construct(s)" were used for mechanical testing per ISO 14801. However, it does not specify the sample size (number of units) for these tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) as the tests are bench-based engineering tests rather than clinical studies with patient data.

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

This information is not applicable to this type of device and study. The "ground truth" here is based on engineering principles, material properties, and established test standards (like ISO 14801), not on expert consensus for clinical interpretations or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective engineering measurements and evaluations against established standards, not subjective assessments requiring adjudication.

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

This is not applicable. The device is a dental implant system (hardware), not an AI or software as a medical device (SaMD) that involves human readers or clinical image interpretation.

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

This is not applicable as the device is a dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering principles and rationale: Used to determine if components constitute a "new worst-case" mechanically or for cleaning/sterility.
• Standardized bench testing: Specifically mentioned ISO 14801 for mechanical fatigue testing and static torque to failure.
• Biocompatibility standards: Application of ISO 10993-1.
• Sterilization standards: Validation per ISO 17665.
• Comparison to predicate devices: The established performance and characteristics of the legally marketed predicate devices serve as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device submission, which involves physical implants and abutments rather than machine learning algorithms.

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

This is not applicable, as there is no training set mentioned or implied for this type of device.

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