Search Results

The Customized Abutments are intended use for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement- retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant System:

1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0
2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0
4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0

All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.5, 3.75, 3.8, 4.0, 4.3, 4.5, 4.6, 5.0, 6.0 mm and Hex connection design.

Customized abutments are supplied with an abutment and provided non-sterile.

This document is a 510(k) Premarket Notification from ARUM DENTISTRY Co., Ltd. for a dental device called "Customized Abutment." This notification aims to demonstrate the substantial equivalence of their device to legally marketed predicate devices, as required by the U.S. Food and Drug Administration (FDA).

Based on the provided information, the 510(k) summary (pages 4-12) details the device, its intended use, materials, and substantial equivalence comparison to a predicate device. The information is focused on a medical device clearance and does not describe an AI/ML-driven medical device, nor does it contain information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because the provided document does not pertain to an AI/ML device.

The document describes a physical medical device (Customized Abutment for dental implants) and its non-clinical testing to demonstrate substantial equivalence, primarily through:

• Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static and fatigue testing according to ISO 14801.

The closest information provided to "acceptance criteria" relates to the design parameters of the abutment, such as post height, angle, wall thickness, diameter, and gingival height, which are likely evaluated against engineering specifications and performance standards like ISO 14801.

Ask a specific question about this device

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:

Table 1.

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, a 510(k) Premarket Notification summary for the Elos Accurate® Customized Abutment, outlines the device's indications for use, technological characteristics, and non-clinical testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information typically found in an acceptance criteria and performance study for a medical device that uses an algorithm or AI. This document is for a physical dental abutment, not a device that relies on an algorithm or AI for its function.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets acceptance criteria related to an AI/algorithm-based device. The original document does not offer data points for:

• A table of acceptance criteria and reported device performance (in the context of algorithm performance)
• Sample size for a test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data)
• Sample size for a training set
• How ground truth for a training set was established

The "testing" mentioned in the document (fatigue testing, biocompatibility testing, dimensional analysis) is for the physical material and design of the abutment, not for an algorithm's performance.

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm
• Hiossen TS Implants 3.5mm, 4.0mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111)
• Hiossen TS Implants 3.5mm, 4.0mm (K151858)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

The medical device under consideration is the CreoDent Solidex® Customized Abutment. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a standalone clinical study. Therefore, some of the requested information, such as sample sizes for test/training sets, number/qualifications of experts for ground truthing, adjudication methods, and MRMC studies, is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CreoDent Solidex® Customized Abutment are implicitly derived from its substantial equivalence to predicate devices in material, indications for use, performance characteristics, and dimensions/angulations, backed by non-clinical testing. The performance is assessed against the established standards and the characteristics of the predicate devices.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical testing study focused on mechanical performance and compatibility.

• Study Type: Non-clinical testing, specifically static/fatigue testing, reverse engineering dimensional analysis, and sterilization validation.
• Standards Followed: ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) and ISO 17665-1 (Sterilization validation).
• Purpose: To demonstrate that the CreoDent Solidex® Customized Abutment has sufficient mechanical strength for its intended clinical application and is compatible with the specified Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addressed the differences identified when comparing to predicate devices (compatible implant bodies and angulation).

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

• Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing typically involves a sufficient number of samples to ensure statistical significance for the specific test (e.g., number of abutment-implant assemblies tested for fatigue) but this exact number is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As a non-clinical, in-vitro mechanical testing study, the data is generated in a laboratory setting.

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

• This is a mechanical testing study, not one requiring expert human interpretation of medical images or patient data to establish ground truth. Therefore, this information is not applicable and not provided. The "ground truth" here is the physical performance of the device under defined test conditions per international standards.

4. Adjudication Method for the Test Set

• Not applicable. As a mechanical testing study, adjudication of human interpretations is not involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic or prognostic algorithms read by human experts, which is not relevant for this dental implant abutment.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

• Not applicable. This device is a physical medical device (an abutment for dental implants), not a software algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is established through physical measurements and adherence to international mechanical testing standards (ISO 14801:2007E). The benchmarks are defined by these standards, the performance of the legally marketed predicate devices, and the physical properties of the materials and design.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, and the validation process described is for its mechanical integrity and compatibility, not for an algorithm that requires a training set.

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

• Not applicable as there is no training set for a physical device like this.

Ask a specific question about this device

The BHdental Implant 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 chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.

The provided text describes the BHdental Implant System, which is a dental implant device. For medical devices like this, "acceptance criteria" and "device performance" are typically demonstrated through compliance with recognized standards and specific performance testing, rather than through studies involving human test sets, expert ground truth, or AI comparative effectiveness as would be common for diagnostic AI software.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of this device and the provided documentation. The performance testing described is primarily mechanical, material, and biocompatibility testing, not clinical studies with human "test sets" in the diagnostic AI sense.
• Data Provenance: Not applicable. The data comes from laboratory and material testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for dental implant material and mechanical properties is established by the specifications in the standards (e.g., ISO, ASTM) and the results of laboratory tests performed by qualified technicians/engineers.

4. Adjudication method for the test set:

• Not applicable. The "test set" consists of physical devices or materials undergoing engineered tests, not clinical cases requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers interact with AI, which is not the case for this dental implant device.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering standards and material specifications (e.g., the strength required by ISO 14801 for fatigue, the chemical composition specified in ASTM F136, the biological response deemed safe by ISO 10993). Test results are compared against these predetermined specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI model, so there is no "training set."

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

• Not applicable. There is no AI training set.

Ask a specific question about this device

The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems:

• Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867)
• Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239)
• Zimmer Tapered Screw-Vent (K061410)
• Straumann SynOcta (K061176)

The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises

• Titanium bases TiBase and Camlog
• inCoris ZI meso blocks
• Sirona Dental CAD/CAM Design and fabricating devices

Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.
inCoris ZI meso blocks are used in manufacturing individually designed inCoris ZI meso mesostructures, which are glued to a fitting titanium base after milling and sintering.
Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.

The provided document is a 510(k) summary for a dental CAD/CAM system. It does not contain information about studies involving acceptance criteria in the traditional sense of AI/ML performance evaluation (e.g., sensitivity, specificity, accuracy, F1-score). Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, materials, design, and physical/performance characteristics.

Therefore, many of the requested categories for AI/ML study details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to the content presented in this 510(k) summary.

The closest equivalent to "acceptance criteria" and "device performance" in this context are the physical and chemical properties of the materials and the design/functional equivalence to established predicate devices.

Here's an attempt to extract relevant information given the nature of the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for overall device performance. Instead, it compares the new device's characteristics to those of predicate devices, arguing for "substantial equivalence." The performance characteristics listed are material properties and design features.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a medical device submission based on substantial equivalence to existing predicate devices, not a clinical or performance study with a test set of data. The "testing" referred to is nonclinical (fatigue analysis, reverse-engineering for design equivalence).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a test set is not relevant in this context. The document relies on engineering analysis and comparison against established standards and predicate device specifications.

4. Adjudication method

Not applicable. Adjudication methods are used in studies involving expert review, which is not described here.

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 is a CAD/CAM system for fabricating dental restorations, not an AI-assisted diagnostic or interpretive device involving human readers.

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

Not applicable. The CAD/CAM system involves an optical acquisition unit, software for design (human-in-the-loop), and milling machines. It's not a standalone algorithm in the AI/ML sense.

7. The type of ground truth used

For the material and physical properties, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5832-3:1996 for TiBase material, ISO 13356:1997 for inCoris ZI meso material) and direct comparison to predicate device specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm requiring learning from data.

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

Not applicable.

Ask a specific question about this device