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Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.

The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.

Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.

Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.

The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.

The document provided is a 510(k) summary for a dental device, "Additive Manufacturing Zirconia Customized Restoration." It describes the device, its indications for use, and a comparison to predicate devices, along with performance and biocompatibility data to demonstrate substantial equivalence.

However, the provided text does not contain any information regarding a study involving human readers or AI assistance, or any performance data related to AI algorithms or human-in-the-loop performance. The performance data section refers to mechanical and biocompatibility testing of the physical dental restoration itself, not to the performance of any AI component.

Therefore, many of the requested details about acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not available in this document.

Below is a summary of the information that is present in the document.

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

The acceptance criteria are generally implied by adherence to ISO standards for dental ceramic materials. The performance values are reported in comparison to the predicate devices.

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

The document does not specify sample sizes for mechanical or biocompatibility testing, nor does it refer to a "test set" in the context of data for an AI/software device. The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the performance tests.

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 as the device is a physical dental restoration, not an AI or imaging device requiring expert interpretation for ground truth.

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

This information is 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

This information is not applicable. The document describes a physical dental device; there is no mention of an AI component or MRMC study.

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

This information is not applicable as the device is a physical dental restoration, not an AI algorithm.

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

For the mechanical and biocompatibility testing, the "ground truth" is established by the relevant ISO standards and validated laboratory test methodologies. For example, for flexural strength, the ground truth is the measured force at fracture, evaluated against the standard's requirements.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning model.

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

This information is not applicable.

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Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.

Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.

The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.

The Franz Zirconia Dental Crown is a dental prosthesis for partially edentulous patients to restore chewing function. It is a single crown cemented to an artificial or natural tooth abutment.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance:

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NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.

NobelProcera®HT ML FCZ Bridge is an individualized cement retained dental restoration manufactured from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Bridge is intended to be a replacement for a natural teeth. After finalizing the NobelProcera®HT ML FCZ Bridge in the dental laboratory, it is cemented or bonded on prepared teeth or artificial abutments by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Bridge is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Bridge is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the bridge using NobelDesign or supported third party CAD systems. The bridge, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
The NobelProcera® HT ML FCZ Bridge is manufactured from a solid piece of yitria-stabilized tetragonal zirconia. It is available in 6 shades and for bridges between 2 and 14 units.

This looks like a 510(k) summary for a dental bridge, and as such, it does not contain the kind of performance study details you'd typically find for a device with complex algorithms or AI components that require clinical validation against acceptance criteria. The device is a physical dental prosthetic, not a software or AI-driven diagnostic tool.

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way you've outlined for AI or software validation.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.

Here's an attempt to address your request based only on the provided text, noting where information is not available or not applicable:

Acceptance Criteria and Device Performance Study for NobelProcera® HT ML FCZ Bridge

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this type of dental prosthetic primarily revolve around the biocompatibility and mechanical properties of the material, and its equivalence to already cleared devices. The document explicitly states that the device leverages the clearance of its material and the substantial equivalence to predicate devices, thus directly addressing these aspects rather than presenting specific numerical acceptance criteria for a new performance study.

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

• Sample Size: Not applicable. No dedicated "test set" in the context of a performance study for AI/software is mentioned. The assessment relies on the properties of the material and comparison to predicate devices, not on a new clinical or observational study with a test set of data.
• Data Provenance: Not applicable. The data primarily consists of the chemical composition and established properties of the ziconia material (Katana Zirconia K143439) and the characteristics of predicate devices (K153534, K071182).

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

• Not applicable. This is not a study requiring human expert assessment for ground truth determination, as it's a physical dental device. The determination of "ground truth" for a physical material typically comes from standardized material testing and regulatory guidelines.

4. Adjudication method for the test set

• Not applicable. There was no test set requiring adjudication in this submission.

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 an AI/software device. No MRMC study was conducted.

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 bridge), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For a physical device like this, "ground truth" pertains to the established material properties (e.g., strength, biocompatibility) of the zirconium oxide, as well as the manufacturing consistency according to established quality systems. The document states the material (Katana Zirconia) is cleared for its intended use, implying its properties meet regulatory standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As there is no training set mentioned or implied, the method of establishing its ground truth is irrelevant.

In summary, this 510(k) submission for the NobelProcera® HT ML FCZ Bridge is based on demonstrating the safety and effectiveness through substantial equivalence to legally marketed predicate devices and by leveraging the prior clearance of the material used. It does not present a de novo performance study with acceptance criteria in the manner one would see for an AI or software-as-a-medical-device (SaMD) product.

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NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.

NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.

NobelProcera® HT ML FCZ (High Translucent Multi Lavered Full Contour Zirconia) Crown is an individualized dental restoration made from translucent multi-layered zirconia material.

NobelProcera® HT ML FCZ Crown is intended to be a replacement for a natural tooth. After finalizing the NobelProcera® HT ML FCZ Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Crown is suitable for cut-back (veneering) or stain and glaze techniques.

The design of the NobelProcera® HT ML FCZ Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using the NobelProcera® system (NobelDesign) or supported third party CAD systems. The crown, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.

The provided document is a 510(k) premarket notification for a dental device, the "NobelProcera HT ML Full Contour Zirconia Crown." It details the device's description, indications for use, and a comparison to predicate devices for substantial equivalence.

However, the document explicitly states: "No clinical or non-clinical test data was used to support the substantial equivalence determination."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria because such data is not present in the provided text. The FDA's substantial equivalence determination for this device was based on technological characteristics and comparison to already cleared predicate devices, rather than new performance testing.

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Bioactys® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.

BIOACTYS® is a sterile single use bioresorbable bone void filling substitute. BIOACTYS® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. Following placement in the bony voids or gap, BIOACTYS® resorbs and is replaced with bone during the healing process. BIOACTYS® is available in the form of granules.

This is a 510(k) summary for a medical device (BIOACTYS®), not a study report for an AI/ML powered device. As such, it does not contain information on acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert involvement, or MRMC studies) in the context of an AI/ML evaluation.

The document states:

• Intended Use: BIOACTYS® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.
• Technological Characteristics: BIOACTYS® and the predicate devices have the same technological characteristics (60% Hydroxyapatite/40% β-Tricalcium Phosphate, similar porous structure, sterile, single-use, promote bone ingrowth by osteoconductivity).
• Non-clinical Performance Data: In vitro tests, performed according to the Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (April 28, 2005), support the substantial equivalence between BIOACTYS® and the predicate devices.
• Conclusion: BIOACTYS® is claimed to be substantially equivalent in terms of safety and effectiveness to the predicate devices as a non-structural osteoconductive bone void filler for osseous defects.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The "study" mentioned here refers to in vitro tests to demonstrate substantial equivalence to predicate devices, not an AI/ML performance evaluation.

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Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.

Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

The provided text is a 510(k) summary for the Nobel Biocare Procera Bridge Zirconia device. It primarily focuses on the device description, indications for use, and regulatory classification, stating its substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies. The 510(k) process for this type of device (a Class II Porcelain Tooth) largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than on generating new clinical performance data with specific acceptance criteria.

Therefore, for your request, I must report that the requested information is not available within the provided text. The document is a regulatory submission for premarket notification, not a performance study report.

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PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.

The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.

Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration.

The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).

The provided text is a 510(k) summary for a dental device, the Lifecore PrimaConnex™ Ceramic Coping. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with specific acceptance criteria, statistical analyses, or detailed performance metrics typically found in clinical trial reports for diagnostic or AI-driven devices.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth details, effect sizes) are not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Since this is a submission for a device component (ceramic coping for dental restorations) and the 510(k) process focuses on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or reader agreement) in this document. Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to existing, legally marketed predicate devices, primarily based on material conformity and intended use.

The device performance is described in terms of its characteristics and conformity to standards, rather than clinical efficacy data.

Study Information

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

   • Not applicable/Not provided. This is a material and design equivalence submission, not a study evaluating performance on a patient test set.

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

   • Not applicable/Not provided.

3. Adjudication method for the test set:

   • Not applicable/Not provided.

4. 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 an AI-driven device or a diagnostic device subject to MRMC studies.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate devices and the conformity of the new device's material and design to relevant standards which ensures performance comparable to the predicates without raising new safety/effectiveness concerns.

7. The sample size for the training set:

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

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Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.

Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.

The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.

This document is a 510(k) summary for a dental device, the Procera® Bridge Laminate. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information.

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Nobel Biocare's Procera Bridge Alumina is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.

Nobel Biocare's Procera® Bridge Alumina is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.

The Procera® Bridge Alumina may be two, three, or four units and is precision milled. The Procera Bridge Alumina can be cemented or bonded to either natural or artificial tooth abutments. It is personalized according to the specific dimensions of the patient's so the bridge precisely fits, and properly functions, in the patient's jaw.

Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).

The provided text describes a medical device, the Nobel Biocare Procera® Bridge Alumina, and its regulatory clearance (510(k)). However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a 510(k) summary and the corresponding FDA clearance letter. These documents confirm that the device is substantially equivalent to a predicate device and is cleared for marketing. They specify the device's description, indications for use, and regulatory classification but do not include details about performance studies used to demonstrate safety and effectiveness for a new device submission or a comparative effectiveness study.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
• 2. Sample sized used for the test set and the data provenance: This information is not present in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided text.
• 4. Adjudication method: This information is not present in the provided text.
• 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 present in the provided text. The device is a physical dental bridge, 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 present in the provided text. The device is a physical dental bridge, not an algorithm.
• 7. The type of ground truth used: This information is not present in the provided text.
• 8. The sample size for the training set: This information is not present in the provided text.
• 9. How the ground truth for the training set was established: This information is not present in the provided text.

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Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may consist of two to eights units and is cemented to natural or artificial tooth abutments.

Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procerat Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

The provided text is a 510(k) Summary for a dental device (Procera® Bridge Zirconia), which describes its intended use and regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt for proving the device meets acceptance criteria.

The document is a regulatory submission for a physical dental prosthesis, not a software algorithm, and therefore the concepts of "test set," "training set," "experts," "adjudication," "MRMC," or "standalone performance" as they relate to AI/software performance evaluation are not applicable here.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets these criteria based on the provided text.

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