Search Results

Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Burn-out Cylinder is a component of a dental implant abutment used in the process of fabricating the dental abutment and the prosthetic restoration. The Burn-out Cylinders are modified by the dental lab and incorporated into the wax framework pattern which is cast into a final gold alloy form. Burn-out Cylinder is made with PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).

Angled Screw Abutment is a dental abutment intended for multi-unit loaded restorations and combined with the burn-out cylinder for increasing the post height to be 4mm at minimum when used for single-unit loading. Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). The Dentium angled screw abutments were originally cleared under 510(k) K141457. All subject device abutments are compatible with Implantium dental implants of Dentium Co., Ltd. Abutments are supplied non-sterile and autoclaved by the end user.

This document is a 510(k) summary for a medical device called "Burn-out Cylinder and Angled Screw Abutments." It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is a dental implant component, a class II device under regulation 21 CFR 872.3630. The acceptance criteria and the study proving it meets these criteria are primarily based on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with human readers or a standalone AI algorithm.

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the relevant FDA guidance and ISO standards for dental implants, specifically demonstrating mechanical performance equivalent to or better than predicate devices.

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

The document does not specify the precise number of devices or components used for each individual mechanical test (e.g., how many abutments were subjected to fatigue testing). It refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a selection of configurations that would be most challenging.

• Sample Size: Not explicitly stated as a number of units. The testing is described qualitatively ("worst case scenario") rather than quantitatively with specific sample sizes per test type.
• Data Provenance: The tests are "Non-clinical testing performed in accordance with FDA Guidance" and ISO standards. This indicates laboratory testing, likely conducted by the manufacturer or a contracted testing facility. There is no mention of country of origin for mechanical testing data, but the manufacturer is based in Korea. This is not retrospective or prospective data in the clinical sense, but rather bench testing 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 submission. The "ground truth" for this device's performance is established by objective physical measurements and engineering standards (e.g., whether a device fractures under a certain load, or passes a specified number of fatigue cycles). Expert review in the context of imaging or diagnostic accuracy is not relevant here.

4. Adjudication Method

This information is not applicable. Adjudication methods are typically used in clinical trials involving human interpretation of data, such as medical images, where there might be disagreement among experts. For mechanical testing, the failure or success is objectively determined by the test apparatus and criteria.

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 specifically for evaluating the effectiveness of a diagnostic device or AI algorithm, often in the context of human interpretation of medical data, which is not relevant for a dental implant abutment.

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

No, a standalone performance study (referring to an algorithm's performance) was not done. This device is a physical medical component, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Objective Engineering Standards: Adherence to ISO 14801:2007 (for fatigue and static load failure).
• Absence of Failure: The primary ground truth is the absence of fracture, cracks, or severe distortion under specified mechanical loading conditions, and the ability to withstand 5,000,000 cycles without failure at the fatigue limit.
• Predicate Device Equivalence: The ultimate ground truth for regulatory purposes is demonstrating substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as existing devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical testing for this type of medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set mentioned or implied for this device's evaluation.

Ask a specific question about this device

Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.

Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

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

The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.

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

The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.

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 here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical bench testing.

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 an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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 physical medical device, not a software algorithm.

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

The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) summary for a dental device, the "P.004 RC/NC Gold and Titanium Abutment for Bars." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or performance studies with detailed metrics.

Therefore, the information required in your request cannot be fully extracted from this document, as it describes a regulatory submission process based on equivalence rather than detailed performance study results.

Here's a breakdown of why and what little can be inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria or detailed performance data (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way a clinical or technical validation study would. The document states, "The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "proof" presented for regulatory acceptance under the 510(k) pathway.

• Study That Proves the Device Meets Acceptance Criteria: There is no specific study described that "proves" the device meets acceptance criteria in the manner of defining and then testing against specific performance thresholds. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technological characteristics, materials, and intended use, often supported by non-clinical bench testing for mechanical properties (though not detailed here), rather than multi-reader studies or ground truth comparisons.

Given these limitations of the provided text, here's what can be answered, and what cannot:

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

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

• Not Applicable. This document does not describe a clinical or performance study with a "test set" in the context of AI/diagnostic device validation. It's a regulatory submission based on substantial equivalence to existing devices.

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)

• Not Applicable. There is no "ground truth" establishment or expert review detailed in this document.

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

• Not Applicable. No test set or adjudication method is described.

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

• No. This document does not describe an MRMC study. The device is a physical dental abutment, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a physical medical device (dental abutment), not an algorithm.

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

• Not Applicable. The concept of "ground truth" for comparative performance evaluation is not relevant to this 510(k) submission, which relies on demonstrating equivalence in design, materials, and intended use to predicate devices.

8. The sample size for the training set

• Not Applicable. No training set is described.

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

• Not Applicable. No training set or ground truth establishment is described.

Ask a specific question about this device

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.

The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.

The provided text is a 510(k) summary for a medical device (ITI Esthetic Ease Abutments) and does not describe acceptance criteria, a study proving device performance, or any of the other requested information related to an AI/ML-based device performance study.

The document is a regulatory submission for a dental implant abutment, outlining its description, intended use, and substantial equivalence to previously cleared predicate devices based on material and design specifications. It is a standard medical device clearance document, not a study report or performance evaluation in the context of AI/ML or a clinical trial with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device