Search Results

The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Overdenture Bars are computer aided design (CAM) precision milled, individually designed Superstructures manufactured for each patient. The NobelProcera Overdenture Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite or porcelain veneer.

The Superstructures can be either Fixed Shaped Bars such as Dolder, Hader, Round, or Free Form Shaped Bars such as Free Form Milled, Montreal, Paris, Wrap-around; or a combination of shapes. The Overdenture Bar shapes and design parameters remain unchanged from the predicate device, Procera Implant Bridge Overdenture (K090069). Additionally, the Superstructure can also be designed per specific prescription order by qualified health care professionals.

The Superstructure is a multiple unit restoration for fixed or removeable dental prosthetic framework milled from one solid piece of material. The NobelProcera Overdenture Bar accommodates commercially available denture attachments for removable dental prosthesis, or retention elements for fixed dental prosthesis.

The many abutment and implant interfaces that can be used in the Superstructure are precision milled and are an integral part of the Overdenture Bar.

The NobelProcera Overdenture Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the NobelProcera Overdenture Bar is matched to a denture for final placement.

The provided text describes a 510(k) summary for the NobelProcera Overdenture Bar, which is a dental device. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, Procera® Implant Bridge Overdenture (K090069), and to expand the list of compatible implant and abutment interfaces. The information provided focuses on the device's design, materials, manufacturing, intended use, and a comparison with the predicate device, along with the results of non-clinical testing.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The "test set" for demonstrating safety and effectiveness of additional implant and abutment interfaces was a retrospective study of NobelProcera Overdenture Bars placed in the market globally since 2010.
• Sample Size: The exact number of overdenture bars or patients included in this retrospective study is not specified in the provided text.
• Data Provenance:
  • Country of Origin: Globally since 2010.
  • Retrospective or Prospective: Retrospective.

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

The document does not mention the use of experts to establish ground truth for the retrospective study on compatible interfaces. The "data set of compatible implant and abutment interfaces were generated through measurements of original manufacturer's bar interfaces." This implies engineering measurements and specification comparisons, rather than clinical expert consensus on outcomes.

4. Adjudication Method for the Test Set

Not applicable. The study described is based on measurements and a retrospective review of market performance, not on a clinical assessment by experts requiring adjudication.

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

No. The provided text does not describe an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a physical dental overdenture bar, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical product, not an algorithm, and thus does not have a "standalone" or "human-in-the-loop" performance as typically understood for AI/software devices. The "algorithm" aspect refers to the CAD/CAM manufacturing process, which is inherent to creating the physical device.

7. Type of Ground Truth Used

• For the additional implant and abutment interfaces: Measurements of original manufacturer's bar interfaces. This refers to engineering specifications and compatibility checks.
• For overall safety and effectiveness: The retrospective study implicitly relies on real-world performance data of the device in the market, although the specific metrics or "ground truth" for assessing this performance retrospectively are not detailed (e.g., lack of reported failures, successful chewing function, etc.).
• For fatigue and MR safety: Standards compliance and non-clinical test results were used as ground truth.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device manufactured via CAD/CAM, there isn't a "training set" in the context of machine learning algorithms. The design parameters are based on established dental anatomy, engineering principles, and the specific interfaces of compatible implants/abutments.

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

Not applicable, as there is no "training set" in the context of AI/machine learning. The design and manufacturing process relies on:

• Clinical and engineering specifications: Defining the various bar shapes (Dolder, Hader, Round, etc.) and their dimensions.
• Compatibility standards: Ensuring precision milling to fit specific implant and abutment interfaces.
• Established dental principles: For restoring chewing function in edentulous jaws.

The "ground truth" for the manufacturing process would be the accurate replication of the patient-specific design within specified tolerances, which is verified through quality control and fit checks against the master cast.

Ask a specific question about this device

Ask a specific question about this device

The NobelProcera Zi Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

The NobelProcera Zi Abutment Thommen Platforms device did not undergo clinical testing and therefore does not have traditional acceptance criteria based on performance metrics like sensitivity or specificity. Instead, the testing focused on validating the device's mechanical integrity and substantial equivalence to existing predicate devices.

Here's a breakdown of the available information:

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

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

• Sample Size for Test Set: The document mentions "worst-case test samples" for fatigue testing. The exact number of samples is not specified.
• Data Provenance: The testing was "non-clinical test data," indicating laboratory or engineering testing. The country of origin and whether it was retrospective or prospective is not specified, though it would typically be conducted by the manufacturer in a controlled lab setting (prospective in that context).

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 device did not involve human interpretation or diagnostic assessment. Therefore, there were no experts used to establish ground truth in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for mechanical testing would be the engineering specifications and performance expectations outlined in the FDA guidance document.

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

• Since the testing was non-clinical and focused on mechanical performance, there was no adjudication method involving human experts for a test set. The evaluation would have been based on established engineering and materials science principles.

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 MRMC comparative effectiveness study was done. This device is a dental implant abutment, not an AI-powered diagnostic tool.

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

• This question is not applicable as the device is a physical dental implant component, not an algorithm.

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

• For the non-clinical testing, the "ground truth" was based on engineering specifications and performance requirements as outlined in the FDA guidance document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance provides the standards for fatigue and other mechanical tests.

8. The sample size for the training set

• This question is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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

• This question is not applicable as there was no training set for this device.

Ask a specific question about this device

NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

The NobelActive GoldAdapt Abutment is an endosseous dental implant abutment intended to be used with the NobelActive implant system. The NobelActive GoldAdapt is made of gold alloy and comes in engaging and non-engaging styles.

NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

The provided text is a 510(k) summary for the NobelActive GoldAdapt Abutment and NobelActive Internal Connection Implant. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance as would be found for a novel device or AI/software as a medical device (SaMD).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the core of a 510(k) submission for this type of device (dental implant components). The studies typically performed for such devices are focused on mechanical strength, biocompatibility, and fit, often by comparing them to the predicate devices or established standards, rather than clinical performance metrics in the way a diagnostic AI would be evaluated.

Ask a specific question about this device

Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.

This document is a 510(k) summary for a medical device called "NobelReplace Hexagonal Implants." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with pre-defined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of typical AI/diagnostic device performance studies.

Here's why and what information is available:

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

• Not Applicable. The document is a 510(k) summary for a dental implant. It aims to show that the new implant (NobelReplace Hexagonal Implant) is substantially equivalent in design and intended use to a previously cleared implant (NobelReplace Tapered Conical Connection, K062566).
• The "performance" described relates to the design changes (internal square was changed to internal hexagonal connection) and how these changes do not alter the fundamental safety and effectiveness of supporting prosthetic devices for esthetics and chewing function. There are no performance metrics like sensitivity or specificity because it's a physical implant, not a diagnostic algorithm.

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. No test set or data of this nature is mentioned or required for this type of device submission.

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. No ground truth establishment for a diagnostic test is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not a diagnostic device that would involve human readers or AI assistance.

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

• Not Applicable. This is a physical implant, not an algorithm.

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

• Not Applicable. For this device, "ground truth" would be related to the established clinical efficacy and safety of the predicate device and the new device's ability to maintain those characteristics through design equivalency.

8. The sample size for the training set

• Not Applicable. No training set is involved for this type of device submission.

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

• Not Applicable.

Summary Pertaining to the Provided Document (KO-73142):

The document is a US FDA 510(k) summary for a dental implant. Its purpose is to demonstrate substantial equivalence to a predicate device, not to present performance data from a clinical study on diagnostic accuracy or AI performance. The key points from the document are:

• Device Name: NobelReplace Hexagonal Implant
• Predicate Device: NobelReplace Tapered Conical Connection (K062566)
• Key Change: The internal connection was changed from a square to a hexagonal design.
• Demonstration of Performance/Equivalence: The submission implies that this design change does not alter the fundamental indications for use or the safety and effectiveness of the device compared to the predicate. The FDA's review and clearance indicate their agreement with this assessment of substantial equivalence.
• Acceptance Criteria (Implied for 510(k)): The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device is as safe and effective as a legally marketed predicate device, and that any technological differences do not raise different questions of safety and effectiveness. This is achieved through detailed device descriptions, comparison tables (which are not in the provided snippet but would be part of a full 510(k)), and potentially mechanical testing (though not explicitly detailed in this short summary) rather than clinical performance metrics for a diagnostic algorithm.

Ask a specific question about this device

Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or nonsplinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare's NobelReplace Tapered Conical Connection implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelReplace Tapered Conical Connection implants are similar in design to the NobelReplace Tapered implants cleared under "Groovy Implants" (K050258). Like the NobelReplace Tapered implant, the NobelReplace Tapered Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body contour, grooves on the collar, grooves on the threads of the body, and a TiUnite surface treatment. The difference between the two implants is that the NobelReplace Tapered Conical Connection implants have the same internal connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003). The internal conical connection allows for the use of SFB abutments.

This document is a 510(k) summary for a dental implant device (NobelReplace Tapered Conical Connection) and does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text is primarily a descriptive summary of the device, its indications for use, and the FDA's substantial equivalence determination. It references predicate devices but does not detail a study conducted for this specific device to demonstrate performance against acceptance criteria.

Therefore, I cannot provide the requested table and study details based on the provided input.

Ask a specific question about this device

The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.

The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.

The provided text is a 510(k) summary for the "Zygoma Angled Abutments." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets specific performance metrics.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: The document does not specify any performance-based acceptance criteria or report performance data. It states the device "is intended to be used as a prosthetic component directly" and "is intended for use as an aid in prosthetic rehabilitation," but these are indications for use, not performance metrics.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: No 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: This is not an AI device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI algorithm.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set ground truth is described.

The document's purpose is to establish substantial equivalence for market clearance, not to demonstrate performance against specific technical criteria through a detailed study summary.

Ask a specific question about this device

Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw in order to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function.

Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Nobel Biocare USA, LLC for a dental implant named "Zygoma TiUnite". It confirms substantial equivalence to predicate devices and outlines regulatory requirements.

Therefore, I cannot extract the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing training set ground truth.

Ask a specific question about this device

NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.

NobelRondo Dental Ceramic – Zirconia is dental porcelain intended for use in the construction of zirconium oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides. The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added. The NobelRondo Dental Ceramic – Zirconia is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.

The provided text describes a 510(k) submission for a dental ceramic product, NobelRondo Dental Ceramic – Zirconia. It outlines the device description, indications for use, and a list of performance standards to which it conforms. However, it does not contain information about a specific study designed to prove the device meets acceptance criteria, nor does it provide detailed device performance metrics in the way typically expected for clinical or performance studies.

The document primarily focuses on regulatory compliance through adherence to recognized consensus standards for dental ceramics and biocompatibility.

Therefore, many of the requested items cannot be extracted from this text.

Here's an attempt to populate the table and answer the questions based only on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text explicitly states "NobelRondo Dental Ceramic – Zirconia conforms with the following standards". It does not report specific numerical performance data against these standards, but rather claims conformity.

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 in the document. The text refers to conformity with standards but does not detail any specific test sets or studies that were conducted to demonstrate this conformity.

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

This information is not provided in the document.

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

This information is not provided in the document.

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 provided in the document. The device is a dental ceramic, not an AI-assisted diagnostic tool.

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

This information is not provided in the document. The device is a dental ceramic, so this type of study is not applicable.

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

This information is not provided in the document. The "ground truth" here is implied to be adherence to the specifications and performance requirements outlined in the cited ISO standards, likely demonstrated through material testing, but the details of such testing are not included.

8. The sample size for the training set

This information is not provided in the document. The device is a physical material, not a machine learning model, so the concept of a "training set" is not applicable in this context.

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

This information is not provided in the document (and is not applicable for this type of device).

Ask a specific question about this device