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Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile.

The provided text is a 510(k) Premarket Notification for a dental device, "Dental Ceramic Blocks." This document does not include information about AI/ML device performance or a study demonstrating the device meets acceptance criteria related to AI/ML.

The device described is a physical material (dental ceramic blocks) used to fabricate dental restorations. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance testing of these physical blocks, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies because the provided document does not pertain to an AI/ML device.

However, I can extract the information related to the physical device's performance acceptance criteria and proof if that is what you are looking for.

For the physical device (Dental Ceramic Blocks), here's what the document states regarding acceptance criteria and performance:

1. Table of acceptance criteria and reported device performance:

Note: The document explicitly states "Although the results have slightly difference, they meet the acceptance criteria. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices" for Flexural Strength and Radioactive properties.

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

• The document does not specify sample sizes for non-clinical performance and biocompatibility tests. It only lists the standards followed (e.g., ISO 4049, ISO 10993 series).
• Data provenance: Not explicitly stated, but implies lab testing. No information on country of origin of data. These are non-clinical / bench tests, not patient data trials.

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

• Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device. Ground truth is established by laboratory measurement standards (e.g., ISO standards).

4. Adjudication method for the test set:

• Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device.

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 document is not about an AI/ML device.

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

• Not applicable. This document is not about an AI/ML device.

7. The type of ground truth used:

• For the physical properties (Flexural Strength, Radiopacity), ground truth is established by standardized laboratory measurement methods outlined in ISO 4049 and ISO 7491.
• For Biocompatibility, ground truth is established by adherence to ISO 10993 series standards test methods (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity).

8. The sample size for the training set:

• Not applicable. This document is not about an AI/ML device, so there is no "training set."

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

• Not applicable. This document is not about an AI/ML device.

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Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.

The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.

The proposed device is a single-use device, and provided non-sterile.

This document describes the premarket notification (510(k)) for "Zirconia Dental Ceramics." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove clinical performance or a specific diagnostic accuracy. Therefore, the questions related to AI/ML device performance (e.g., acceptance criteria for accuracy, MRMC studies, ground truth establishment for training/test sets, expert adjudication) are largely not applicable to this type of medical device submission (dental ceramics).

The acceptance criteria and "study" described in this document are focused on non-clinical performance testing to demonstrate that the physical, chemical, and biological properties of the Zirconia Dental Ceramics conform to established standards for dental ceramic materials.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:

Acceptance Criteria and Device Performance for Zirconia Dental Ceramics

The acceptance criteria for this device are based on demonstrating compliance with the international standard ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 7405:2018 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry" for biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2).

Metal Ceramic: a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic: A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

The provided text describes a 510(k) summary for a dental ceramic device, which does not contain information about an AI/ML powered device. Therefore, a description of acceptance criteria and studies related to AI/ML performance is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material composition, mechanical properties (flexural strength, solubility, glass transition temperature), and biocompatibility testing.

Here's the information extracted from the provided text, structured to align with the prompt's request where applicable for non-AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for performance testing (mechanical properties) or biocompatibility. The results are presented as single values for each material property type (e.g., flexural strength).
• Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based material characterization studies conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product where expert consensus for ground truth is typically required. The ground truth for material properties is established by recognized international standards (ISO 6872 and ISO 10993).

4. Adjudication method for the test set: Not applicable. This device does not involve subjective assessment requiring adjudication.

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 device is a dental ceramic material, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:

• Mechanical Performance: Ground truth is established by the requirements and methodologies defined in ISO 6872:2008 (and comparison to ISO 6872:2015) for Dentistry - Ceramic materials.
• Biocompatibility: Ground truth is established by the requirements and methodologies defined in ISO 10993 series and USP40 for biological evaluation of medical devices.

8. The sample size for the training set: Not applicable. This device is a material, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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Zirconia Dental Ceramics are intended for crowns, multiunit bridges. Application includes both anterior and posterior bridges.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Zirconia Dental Ceramics." It primarily addresses the substantial equivalence determination for the device and its indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.

The provided document is a 510(k) summary for Aidite Zirconia Dental Ceramics. It explicitly states that "Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US."

Therefore, the device's acceptance criteria are demonstrated through physical, chemical, and biocompatibility testing against established international standards and by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with human subjects.

Here's a breakdown of the requested information based on the document:

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

The acceptance criteria are implicitly defined by the physical and mechanical properties of dental ceramics and the requirements of the predicate device, as well as the ISO standards mentioned. The document provides the device's reported physical and mechanical properties.

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Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

The provided text describes a 510(k) premarket notification for a dental ceramic device named "Fluorcanasite Dental Ceramic" (K100794). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance studies in the way one might see for AI/ML devices or novel therapies.

Therefore, the study design elements typically requested for AI/ML or clinical trials (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this submission. The "study" here is a series of non-clinical, benchtop tests designed to characterize the material properties of the new device and compare them to a predicate device.

Here's an analysis based on the information provided, specifically addressing the criteria where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally that the new device performs "as well as, or better than" the predicate device for relevant characteristics, demonstrating substantial equivalence. The predicate device's performance often serves as the de facto benchmark.

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

• Sample Size: Not explicitly stated as a number of "samples" in a clinical human-subject sense. The non-clinical tests (Biaxial Flexural Strength, CTE, Chemical Solubility, Fracture Toughness, Hardness, MTBS, Biocompatibility, Uranium content) would have involved multiple specimens of the material as per the test methodologies (e.g., ISO standards), but the exact number of specimens is not provided.
• Data Provenance: The non-clinical testing was conducted, and the summary was prepared in the UK (Applicant address: Derbyshire, UK). The Uranium content analysis was managed under "NPL LRQA registration to ISO 9001:2000," indicating a UK National Physical Laboratory (NPL) involvement.
• Retrospective or Prospective: N/A for benchtop material testing.

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

• Experts: Not applicable. Ground truth, in this context, is established by adherence to recognized international standards (e.g., ISO 6872:2008, ISO 10993-5) for material property measurements and radiochemical analysis methodologies.
• Qualifications: Not applicable for this type of submission. The qualifications would be implied by the accreditation and expertise of the laboratories conducting the standardized tests.

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

• Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The measurements are objective material properties.

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 dental ceramic material, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is a dental ceramic material, not an algorithm.

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

• The "ground truth" for this device's performance is derived from standardized material testing methodologies (e.g., ISO 6872:2008, ISO 10993-5) and analytical chemistry techniques (for uranium content), which provide objective, measurable physical and chemical properties of the material.
• The "truth" of comparability is then assessed against the predicate device's reported properties.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

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The Dental Ceramic is indicated for use with the:

• preparation of inlays .
• preparation of onlays .
• preparation of veneers .
• preparation of crowns .

The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, in Bensheim, Germany. The blooks are compatible with all CEREC devices up to The Dental Ocramio is manuted i are compatible with the CEREC model MC XL and Inlab model MC XL.

The present Dental Ceramic blocks are grindable leucite reinforced glass ceramic blocks for use with CEREC® and inLab® devices marketed by Sirona, Bensheim, Germany. The blocks are are compatible with all CEREC models up to CEREC 3 and inLab but are not compatible with the CEREC model MC XL and Inlab model MC XL.

This 510(k) summary for K080479, "Dental Ceramic," does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a dental ceramic material, which is a Class II device. The submission is an "Abbreviated 510(k)" as described in FDA's guidance, meaning it primarily demonstrates substantial equivalence by providing chemical composition and certification of compliance with relevant consensus standards.

Therefore, I cannot provide the requested information in the format specified because the provided text does not describe any specific performance criteria, testing, or studies that would typically be associated with software or AI/ML-driven medical devices.

The key points from the provided text are:

• Device Type: Dental Ceramic blocks (material).
• Purpose: Used for inlays, onlays, veneers, and crowns with CEREC® and inLab® devices.
• Regulatory Pathway: Abbreviated 510(k), demonstrating substantial equivalence through chemical composition and compliance with consensus standards.
• No mention of AI/ML components: The device is a material, not a diagnostic or AI-powered system that would require performance studies against specific acceptance criteria.
• No mention of studies: The document states "Data provided in this submission to establish substantial equivalence includes chemical composition and certification of compliance with relevant consensus standards." This indicates a different type of evaluation than a clinical or performance study with a test set, ground truth, or expert readers.

If this were a submission for a device involving AI or software, the requested information would be crucial. However, for a dental ceramic, the regulatory requirements for demonstrating safety and effectiveness are met differently, typically through material properties testing and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints.

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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).

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

NobelRondo Dental Ceramic – Alumina is dental porcelain intended for use in the construction of aluminum 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 – Alumina 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.

This document is a 510(k) Summary of Safety and Effectiveness for the NobelRondo Dental Ceramic – Alumina, a dental porcelain. It does not present any data relating to artificial intelligence (AI) or machine learning (ML) device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device that uses AI.

The document discusses the physical properties and intended use of a dental ceramic material and its substantial equivalence to a legally marketed predicate device (Procera® All-Ceramic Dental Porcelain). The FDA's review in this case is focused on the material's safety and effectiveness for its stated dental applications, not on the performance of a diagnostic or assistive AI system.

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The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The provided text is a 510(k) summary for the Sulzer Dental Ceramic System-HexLock. It primarily focuses on comparing the new device to predicate devices to establish substantial equivalence, rather than detailing a study with specific acceptance criteria and performance data in the typical sense of a clinical trial or algorithm validation.

However, based on the information provided, we can infer the "acceptance criteria" through the comparison analysis and the "study" demonstrating that the device meets these criteria is the comparison itself, which aims to show substantial equivalence.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text for a direct fit:

Acceptance Criteria and Device Performance

The core "acceptance criteria" here is that the Sulzer Dental Ceramic System-HexLock is substantially equivalent to existing, legally marketed predicate devices. The "reported device performance" is demonstrated by the comparison of its technological characteristics and intended use to these predicates.

Key Implicit Acceptance Criterion: Substantial Equivalence to predicate devices (HexLock Abutment (K953101) and FRIALIT®-2 CeraBase Abutment (K980630)).

Study Details:

It's important to clarify that this document is a 510(k) summary for regulatory clearance, not a research paper detailing a specific clinical study with granular data. The "study" here is implicitly the substantial equivalence comparison performed by the manufacturer and reviewed by the FDA.

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

   • Test Set Sample Size: Not applicable in the context of a traditional test set for performance parameters. The "test set" is the Sulzer Dental Ceramic System-HexLock itself, and its characteristics are compared against the established characteristics of the predicate devices.
   • Data Provenance: The data provenance is from the specifications and characteristics of the new device and the predicate devices (Sulzer Dental HexLock Abutment and FRIALIT®-2 CeraBase Abutment). The manufacturing site for the new device is listed as Carlsbad, CA (USA), and for one predicate as Meinnheim, Germany. This is a retrospective comparison based on existing device specifications.

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

   • Not applicable as there is no "ground truth" expert consensus established for a test set in this 510(k) summary. The ground truth for the predicate devices' safety and effectiveness was established when they received their own regulatory clearances. For the new device, its specifications are provided by the manufacturer.

3. Adjudication method for the test set:

   • Not applicable. The process is a regulatory review by the FDA (specifically the Division of Dental, Infection Control and General Hospital Devices), comparing the new device's documentation to predicate devices. It is not an adjudication based on multiple expert opinions on a specific test set.

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 device is a dental implant abutment and ceramic coping system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are irrelevant to this submission.

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

   • Not applicable. This is a physical medical device.

6. The type of ground truth used:

   • The "ground truth" in this context refers to the established safety, effectiveness, and regulatory clearance of the predicate devices based on their inherent characteristics, testing, and clinical track record. The new device's ground truth for approval is its "substantial equivalence" to these predicates. This involves comparing engineering specifications, materials, and intended use, likely supported by bench testing (though not detailed in the summary).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

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

   • Not applicable. No training set is involved.

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