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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.

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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.

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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.

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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.

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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.

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