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AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms.

All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

A.B. Dental Devices® CADCAM Products consists of; Base Abutments and Adhesive Sleeves which are used with Standard Platform (Internal Hex connection) implants, Narrow Platform implants and Screw retained (P64 and P14/P16 MultiUnit) abutments.

Base Abutments (standard or narrow platform) and Adhesive Sleeves (screw retained abutment platform) are prefabricated abutments/sleeves made to be used as final abutments/ sleeves that will be used as adhesive connection (cement retained) of the prosthetic restoration on implant platform or on Multiunit platforms.

The design and manufacturing of the patient-specific abutments take consideration the shape of the final prosthesis based on the patient's intra-oral scanning using the manufacturing. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

This submission adds the following Base Abutments and Adhesive sleeves:

Ti Base Anti-Rotational Abutments (Standard or Narrow platforms) - Base Abutment
Ti Base Rotational Abutments (Standard or Narrow platforms) - Base Abutment
P64 Ti Conical Adhesive Sleeve - Adhesive Sleeve
Ti Straight Adhesive Sleeves - Adhesive Sleeve

Base Abutments;
The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

Raw material Zirconium blanks
Dental Direkt Zirconia Blanks by Dental Direkt GmbH, cleared under K183569

Dental Cement
PANAVIA SA Cement Universal by Kuraray Noritake Dental Inc., cleared under K183537

Adhesive Sleeves
The adhesive sleeves are all Rotational (non-engage) for bridges restoration.

The adhesive sleeves are made of Titanium alloy (Ti-6Al-4V ELI) and will be installed on straight or angular screw-retained abutments.

The Multiunit (screw retained abutments already cleared devices) are P14/P16 platform: The below listed devices are previously cleared items that the sleeves are intended to be used with:
P14-3,17-1, P14-3,17-3, P14-3,30-1, P14-3,30-3, P14-3.75,17-1, P14-3.75,17-3, P14-3.75,30-1, P14-3.75,30-3, P16-3.75,1, P16-3.75,2, P16-3.75,3, P16-3.75,4, P16-3.75,5, P64-3,1, P64-3,17-0.5, P64-3,17-2, P64-3,2, P64-3,3, P64-3,30-0.5, P64-3,30-2, P64-3.75,1, P64-3.75,2, P64-3.75,3, P64-3.75,4, P64-3.75,5, P64-3.75,17-0.5, P64-3.75,17-2, P64-3.75,17-3, P64-3.75,30-0.5, P64-3.75,30-2, P64-3.75.30-3

The provided document is a 510(k) Summary for a dental device, not an AI/ML device. Therefore, it does not contain information related to AI/ML acceptance criteria or studies proving device performance from an AI/ML perspective.

However, I can extract the acceptance criteria and performance data for the dental device as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the device in the typical sense of numerical thresholds for metrics like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device through comparison of technological characteristics and non-clinical performance data.

The "acceptance criteria" are implied by the comparison to the predicate device and the successful completion of various non-clinical tests. The "reported device performance" refers to the results of these non-clinical tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a 510(k) submission for a non-AI/ML dental device. The "test set" refers to physical samples for engineering and biological testing, not a dataset of patient information. The provenance of the manufacturing is Israel (A.B. Dental Devices Ltd., 19 Hayalomim St., Ashdod 7761117 Israel) and the testing labs are mentioned (e.g. Nelson Lab).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of AI/ML refers to accurately labeled data against which an algorithm's performance is measured. For this dental device, "ground truth" would be established by validated engineering specifications, material properties, and regulatory standards. The experts involved would be engineers, material scientists, and regulatory affairs specialists. No specific number or qualifications are mentioned for establishing these in the document itself, beyond stating that an "Engineering analysis" was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation by multiple human readers. For the non-clinical tests described, the results are derived from physical measurements and laboratory procedures, not interpretations subject to 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 prosthetic and does not involve AI or human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a dental prosthetic and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and material properties: For design comparisons (e.g., material, dimensions, angulation).
• Validated laboratory testing standards: For cytotoxicity (ISO 10993-5), fatigue (ISO 14801), sterilization (ANSI/AAMI/ISO 17665, ISO 11138), and MRI compatibility (various ASTM standards).
• Predicate device characteristics: The predicate device K181580 serves as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device.

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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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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 one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:

• . P0-3 narrow platform healing caps, 4 and 7 mm length
• PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
• P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
• P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
• . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
• P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
• P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
• P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
• P9HG-3.75 standard platform, composed abutment, gold alloy
• P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
• . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
• . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
• . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
• P64 plastic and Ti alloy sleeve
• P64 healing cap ●
• PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
• PK plastic sleeve
• . PK healing cap

This document is a 510(k) premarket notification for the A.B. Dental Devices® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in a typical medical device AI context.

The "Performance Data" section lists several types of engineering analysis and biocompatibility/sterilization/fatigue testing, but these are for the physical dental implant system itself, not for an AI/algorithm-based diagnostic or assistive device. There is no mention of a "device performance" in terms of clinical metrics like sensitivity, specificity, accuracy, or an effect size for human readers.

Therefore, for the specific questions asked about acceptance criteria and a study proving device performance (especially questions related to AI/algorithm performance), the provided text does not contain the requested information.

Here's why and what's missing:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing the new components (healing caps, abutments) to previously cleared predicate devices based on material, diameter, platform, length, design, and sterility. There are no performance metrics or acceptance criteria for a diagnostic/assistive function.

2. Sample size used for the test set and the data provenance: Not applicable as there is no "test set" for an AI algorithm. The performance data mentioned relates to physical testing (e.g., fatigue testing), but not clinical trials or data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established for an AI algorithm.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This document is not for an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable.

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

In summary, this document is a 510(k) submission for conventional dental implant components, not an AI-powered medical device. As such, it does not contain the information requested about acceptance criteria and studies proving the performance of an AI/algorithm-based device.

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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: I22, I5, I55, I10.

P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:

Abutments:

• P0-14 Healing caps, 2.5 7 mm heights .
• P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
• P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths

This is a 510(k) summary for a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device performance studies is not available in this document.

Here's an analysis of the provided text based on your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in the typical sense for an AI/ML device, as it describes a dental implant system. The performance data presented are primarily related to mechanical and biological safety, not diagnostic accuracy or effectiveness against quantifiable metrics for an AI system.

However, we can infer some "performance data" or testing performed:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The performance data listed (fatigue, cytotoxicity, sterilization, etc.) are standard engineering and biological tests for medical devices, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" for these tests relates to established standards and physical/chemical properties, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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 information is not applicable and not provided. This is a conventional dental implant, not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance tests (fatigue, cytotoxicity, sterilization) would be the established international standards themselves (ISO 14801, ISO 10993-5, ISO 11137, ANSI/AAMI/ISO 17665-1) and their defined pass/fail criteria. For LAL testing, it would be the absence of endotoxins as per FDA guidance.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. This is not an AI/ML device.

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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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