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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.

Two Stage Implants: 12, 15, 16BI.

One Stage: 16, 16b, 16B.

One Stage & One-Piece 3.0 mm diameter implants: 16, 16B1, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;

l2 - Screw Type Implant - Diameter 3.5, Length 8, 10,11.5,13,16

l5 - Conical Implant - Diameter 3.5, Length 8, 10,11.5,13,16

16 - Narrow Integral Implant - Diameter 2.4, 3, 3.2 Length 10, 11.5, 13, 16

l6b - Ball Attachment Implant - Diameter 2.4 Length 10, 11.5, 13, 16

16B - Narrow Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16

16BI - Narrow Implant - Diameter 3 Length 10, 11.5, 13, 16

Abutments System consists of healing caps, screws, Anti-rotation Abutment, Anatomic Anti-rotation Abutment, Narrow / Wide Anti-rotation Abutment, Zirconium Anatomic Abutment, Temporary PEEK Anatomic Anti-rotation Abutment, Long Angular Abutment 15°, Anatomic Angular Abutment 15°, Ball Attachment Abutment, Angular Ball Attachment 20°, Ball for Angular Adaptor, Titanium Sleeve, Anti-rotation Aesthetic Abutment, Composed Hex/Non Hex Abutment, Angular Adaptor, Locator and other superstructures; impression copy system & surgical instruments are also provided.

The provided text describes a 510(k) premarket notification for a medical device, specifically the "A.B. DENTAL DEVICES® Dental Implants System." This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance for such a test.
3. Number of experts, their qualifications, or adjudication methods for establishing ground truth in a test set.
4. A multi-reader multi-case (MRMC) comparative effectiveness study, nor its effect size.
5. A standalone (algorithm-only) performance study.
6. Specific types of ground truth (e.g., pathology, outcomes data) for a test set.
7. Sample size for a training set.
8. How ground truth for a training set was established.

Instead, the document focuses on non-clinical testing and substantial equivalence.

Here's what can be extracted:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" here are compliance with recognized standards and demonstration of properties comparable to predicate devices, rather than performance metrics from a clinical study.

Non-Clinical Study Details:

The study described is not a clinical study with patients, but rather bench testing to demonstrate mechanical performance and a risk assessment to demonstrate safety and effectiveness relative to predicate devices.

• Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the testing would have been conducted on representative samples of the A.B. DENTAL DEVICES® Dental Implants System. The provenance is internal to the manufacturer (A.B. DENTAL DEVICES Ltd., ISRAEL). This is retrospective in the sense that it's testing of manufactured devices for regulatory submission.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is determined by the physical properties and performance against international standards, not expert consensus.

• Adjudication method for the test set: Not applicable to mechanical bench testing.

• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical dental implant system, not a software algorithm.

• The type of ground truth used: For mechanical testing, the ground truth is established by the specified parameters and methodologies of the ISO standards (e.g., specific force, cycles, fracture points). For safety and effectiveness, the ground truth is the established safety profile and performance of the predicate devices.

• The sample size for the training set: Not applicable, as this is not a machine learning algorithm.

• How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a substantial equivalence submission based on compliance with international standards for biocompatibility and mechanical fatigue, along with a comparison of the device's design and materials to legally marketed predicate devices. It does not contain information about clinical trials or performance metrics that would typically be associated with AI or diagnostic device studies.

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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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A.B. 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.

Two-piece implants - I1, I2, I2b & I5: Two-stage implants - 12, 12b & 15 implants:

Onc-stage implants -- 11

One piece implants - 16, 17

Implants for immediate loading when good primary stability is achieved and with appropriate occlusal loading - 12, 12b, 15, 16 & 17.

Not Found

The provided text is a 510(k) clearance letter from the FDA for dental implants. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request using the given input.

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