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Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.

Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439).

Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure.

Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.

Here's a breakdown of the acceptance criteria and study information for the "Esthetic Colorant" device, based on the provided FDA 510(k) summary:

This document is a 510(k) summary for a medical device that colors pre-sintered zirconia structures for dental restorations. It is not an AI/ML device, and therefore several of the requested sections (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, sample size for training set, ground truth for training set) are not applicable.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated how many samples were tested for each physical and chemical property, other than that the properties were evaluated according to ISO 6872:2015.
• Data Provenance: Not explicitly stated, but the company is in Japan (Kuraray Noritake Dental Inc.) so it can be inferred that the testing was conducted there. The testing is prospective as it's for a new product submission.

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

• Not Applicable. This is a material science device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The ground truth refers to adherence to physical and chemical property standards.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing involves objective measurements against established ISO standards.

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 material science device, not an AI/ML device.

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

• Not Applicable. This is a material science device; there is no algorithm or standalone performance in the context of AI.

7. The type of ground truth used

• International Standard Compliance: The ground truth is established by the requirements of the international standard ISO 6872:2015 for dental ceramics. This standard defines the acceptable ranges for physical (flexural strength, coefficient of thermal expansion) and chemical (chemical solubility) properties.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device with a training set.

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

• Not Applicable. See point 8.

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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

This document describes the premarket notification for the KATANA Zirconia Block and demonstrates its substantial equivalence to previously cleared predicate and reference devices.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a table (Table 3-6-3) comparing the subject device (KATANA Zirconia Block (14Z L)), the predicate device (KATANA Zirconia Block (12Z, 14Z)), and the reference device (KATANA Zirconia Disc (ST, STML)) against requirements specified in ISO 6872:2015 (Dentistry — Ceramic materials — Part 1: Dental ceramics).

"COMPLIES" indicates that the test value was within the acceptable range to pass the testing in compliance with the requirements of ISO 6872:2015.

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 explicitly state the sample sizes used for the bench testing. It refers to a "comparative study performed according to ISO 6872:2015," which typically involves specific sample sizes dictated by the standard for each test. The data provenance (country of origin, retrospective/prospective) is not mentioned. However, the applicant is "Kuraray Noritake Dental Inc." in Japan, suggesting the testing was likely conducted by or for this Japanese company.

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 is a physical/mechanical properties test for a dental ceramic block, not a diagnostic medical device that requires expert interpretation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth based on clinical evaluation. The ground truth for these tests is established by adhering to the standards and methods outlined in ISO 6872:2015. Visual inspections (e.g., for uniformity, absence of extraneous materials) would be performed by trained technicians or quality control personnel.

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

Since this is a bench testing scenario focusing on physical and chemical properties against a standard, an adjudication method for conflicting expert opinions (like 2+1 or 3+1) is not applicable. The compliance is determined by instrumental measurements and visual inspections against quantitative and qualitative criteria defined by ISO 6872:2015.

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 performed. This device is a dental material (zirconia block) and not an AI-powered diagnostic tool requiring human reader assistance.

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

This is not an algorithm-based device. It is a physical dental material. Therefore, no standalone algorithm performance study was done. The performance evaluation is based on standard material testing methods.

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

The ground truth for this device's performance evaluation is established by international standards (ISO 6872:2015). The performance is measured against the pre-defined limits and specifications within this standard, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The material is manufactured and tested according to quality control procedures to meet the specified standards.

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

As there is no training set for an algorithm, this question is not applicable.

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The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.

The provided document is a 510(k) summary for the Straumann® Variobase® Abutments, an endosseous dental implant abutment. The primary purpose of this submission is to add new Zirconia ceramic materials (zerion® ML and zerion® UTML Zirconia) as suitable materials for fabricating the coping, crown, or bridge that attach to the Variobase abutment base.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data related to the physical and biological characteristics of the device rather than traditional clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC). The acceptance criteria are based on compliance with established standards and guidance documents.

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

• Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of abutments for fatigue testing, number of samples for cytotoxicity). It only states that "Bench testing was performed."
• Data Provenance: All testing appears to be retrospective bench testing conducted in vitro (laboratory setting) and pre-clinical. There is no indication of human or animal studies. The country of origin of the data is not explicitly stated but is implied to be conducted by or for Institut Straumann AG, a Swiss company with a US subsidiary.

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

• This information is not applicable in the context of this submission. The "ground truth" for the acceptance criteria mentioned (e.g., material compliance, fatigue limits, sterility, biocompatibility) is established by international standards (ISO) and FDA guidance documents, not by individual experts establishing a "ground truth" on a test set in the same way an expert would for a diagnostic AI device. The tests themselves are designed to measure against these established benchmarks.

4. Adjudication Method for the Test Set:

• This information is not applicable. Since the "ground truth" is based on objective standards and measurement rather than expert interpretation of complex data (like medical images), there is no need for an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study assesses reader performance with and without AI assistance for diagnostic tasks. The Straumann® Variobase® Abutments are a physical implant component, not a diagnostic AI device.

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

• No, this is not applicable. The device is a physical medical component, not an AI algorithm. While software validation was performed, it relates to the design and manufacturing software, not a standalone AI diagnostic tool.

7. The Type of Ground Truth Used:

• The "ground truth" for the acceptance criteria is based on established regulatory standards, consensus standards (ISO), and FDA guidance quantitative limits and requirements. For example:
  • Material: ISO 5832-11 for titanium alloys.
  • Dynamic Fatigue: FDA guidance document for Class II Endosseous Dental Implants and Abutments, which sets performance thresholds.
  • Biocompatibility (Cytotoxicity, Extractables): ISO 10993 series standards.
  • Sterilization: ISO 17665 series standards and FDA guidance.
  • Software: FDA guidance and IEC 62304.

8. The Sample Size for the Training Set:

• This information is not applicable. This submission is for a physical medical device, not a machine learning model that requires a training set. The term "training set" is relevant for AI/ML device development.

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

• This information is not applicable for the same reasons as point 8.

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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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