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ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals.

The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia.
They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese.
The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.

The provided document is a 510(k) Premarket Notification for a dental device, ArgenZ MTZ, which is a dental zirconia ceramic. It outlines the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.

This document describes the device itself and its physical and chemical properties, but does not describe a study involving a human expert in the loop (e.g., radiologist) or an AI algorithm for diagnostic purposes. Therefore, many of the requested items related to AI/human performance studies are not applicable to the information contained in this document.

However, I can extract information related to the acceptance criteria for the device's physical and chemical properties and how those properties were tested.

Here's a breakdown of the available information:

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

The document provides a "Substantial Equivalence Comparison Table" that lists various physical and chemical properties and the device's performance against specified criteria, which effectively serve as acceptance criteria to demonstrate equivalence to the predicate device and compliance with ISO standards.

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The Argen Clear Aligner and Argen Clear Aligner Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen clear aligners are comprised of series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.

The provided text describes the "Argen Clear Aligner" and "Argen Clear Aligner Premium" devices. These are orthodontic devices, and the information is from an FDA 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies for AI/software components as would be described for diagnostic AI tools.

Therefore, many of the requested details, such as specific acceptance criteria related to diagnostic performance metrics, sample sizes for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI performance, are not applicable for this type of medical device submission.

This document describes a physical medical device (clear aligners) and its manufacturing process, incorporating a software system (Ortho Analyzer) for treatment planning and design. The "performance data" referred to in Section VII of the 510(k) summary (page 3) relates to physical properties and biocompatibility testing, and verification and validation activities to ensure consistency between the aligner series' design and manufactured aligners. This is distinct from the performance evaluation of a diagnostic AI algorithm.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided:

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

The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's not a diagnostic AI device. The "acceptance criteria" mentioned refer to the manufacturing and design consistency of the physical aligners.

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

This information is not applicable as the device is a physical orthodontic aligner, and its 510(k) submission primarily relies on substantial equivalence and engineering/biological verification and validation, not a clinical study involving a "test set" of patient data for AI performance evaluation. The "software" mentioned (Ortho Analyzer) is a tool for design and planning, not a diagnostic AI.

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 for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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 for the reasons stated above.

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

This information is not applicable. While there is software involved in the design and planning of the aligners (Ortho Analyzer), it is not described as a standalone diagnostic AI algorithm. The process explicitly involves a "dental health professional (dentist/orthodontist)" who "determines a course of treatment" and a "prescribing physician reviews and approves the model scheme." This indicates a human-in-the-loop design and prescription process.

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

This information is not applicable in the context of diagnostic AI performance. For the aligners, the "ground truth" would relate to successful orthodontic treatment outcomes, which are assessed clinically by the treating dentist/orthodontist over time, not through a single reference standard for an AI algorithm.

8. The sample size for the training set

This information is not applicable. The device itself is a physical product. While the "Ortho Analyzer" software likely has an underlying model or algorithm for generating treatment plans, the document does not provide details of its training set, as this is not an AI diagnostic submission.

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

This information is not applicable for the reasons stated above.

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The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner based on an assessment of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.

This document is a 510(k) Premarket Notification for the Argen Clear Aligner. It primarily demonstrates substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Argen Clear Aligner itself. As such, no specific acceptance criteria or a dedicated study proving the device meets those criteria are directly provided for the Argen Clear Aligner's efficacy in tooth alignment.

Instead, the submission relies on the established safety and efficacy of its predicate device and the similarity of its design and materials.

Here's an analysis of what is and isn't available based on your request:

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

• Acceptance Criteria for the Argen Clear Aligner: Not explicitly stated as performance metrics for tooth alignment. The submission focuses on demonstrating substantial equivalence to a predicate device (The Align System, K981095). Therefore, the "acceptance criteria" are implicitly that the Argen Clear Aligner is as safe and effective as the predicate.
• Reported Device Performance of Argen Clear Aligner: No specific performance metrics (e.g., accuracy of tooth movement, treatment success rates) are reported for the Argen Clear Aligner. The document states that "Animal and human performance testing are not required for this product type," indicating clinical efficacy trials were not performed for this 510(k) submission.

The comparison table (Page 5) highlights similarities between the Argen Clear Aligner and the predicate device, which serves as the basis for substantial equivalence:

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

• Sample Size: Not applicable. No dedicated performance study with a test set was conducted for the Argen Clear Aligner for its 510(k) submission. The submission relies on non-clinical performance and biocompatibility testing referencing another device (Dentsply's K062828), which is not detailed here.
• Data Provenance: Not applicable for a performance study of the Argen Clear Aligner. The data presented is for the predicate device comparison and general device description.

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

• Not applicable. No ground truth establishment by experts for a test set is described for the Argen Clear Aligner's 510(k) submission.

4. Adjudication method for the test set

• Not applicable. As no test set performance study was conducted, no adjudication method is mentioned.

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. This device is a physical medical device (clear aligners), not an AI-assisted diagnostic or therapeutic tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not relevant or described.

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

• No. This device is a physical medical device. While software is used in its design (Ortho Analyzer by 3Shape A/S), the submission does not detail a standalone algorithm performance study for tooth movement prediction or clear aligner design, as this is typically handled by the software manufacturer's own submissions. The Argen Clear Aligner is the manufactured product based on the software's output.

7. The type of ground truth used

• Not applicable for a performance study of the Argen Clear Aligner. The "ground truth" implicitly referenced across the entire 510(k) process for substantial equivalence is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set in the context of its 510(k) submission. The "designs" of the aligners are based on physician prescriptions and standard dental software, not a learned model from a training set in the way AI algorithms are trained.

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

• Not applicable. See point 8.

In summary, the provided document is a 510(k) premarket notification primarily demonstrating substantial equivalence due to physical and functional similarities to an existing predicate device. It does not contain a study of the Argen Clear Aligner's clinical performance against specific acceptance criteria, nor does it detail AI algorithm performance metrics.

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ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

1. Acceptance Criteria and Reported Device Performance

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ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.

ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.

The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

The ArgenIS Titanium Abutments are compatible with the following implant systems:

| Implant Brand Name | Platform | Manufacturer | Implant Trade Name | Implant
Line/Connection | Implant Diameter |
|------------------------------------|---------------|------------------|------------------------------------|----------------------------|------------------------------------------------|
| Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm |
| Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,
4.6, 5.1, 5.08,
5.05mm |
| Nobel Active Wide
Platform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active Wide
Platform (WP) | Internal Hex | 5.5mm |

The ArgenIS Titanium Abutments are designed specifically for an individual patient and then milled from a titanium blank with a pre-milled interface correlating to a specific implant system. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used for laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseous implant body with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices.

Minimum and Maximum Gingival Height is 0.5mm - 6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°

All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.

The document primarily focuses on establishing "substantial equivalence" of the ArgenIS Titanium Abutments to legally marketed predicate devices, rather than defining specific acceptance criteria for a new device and proving its performance against those criteria in a typical clinical study.

However, based on the non-clinical performance testing summarized in section 14 and the comparison table in section 13, we can infer some "acceptance criteria" related to the device's physical and mechanical properties, and how it was evaluated.

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

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 does not specify exact sample sizes for the fatigue or dimensional testing. It mentions "worst case scenario samples" for fatigue testing.
• Data Provenance: The data is from non-clinical testing (laboratory testing) and not a clinical study involving human subjects. Therefore, "country of origin of data" or "retrospective/prospective" are not applicable in the typical sense of a human clinical trial. This is manufacturer-led testing.

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 question is not applicable. The evaluations described are technical and engineering-based (fatigue, dimensional analysis, sterilization validation), not subjective assessments requiring expert interpretation of clinical data or images to establish a "ground truth."

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

• This question is not applicable as the testing involves objective measurements against engineering standards and material properties, not subjective assessments 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

• No MRMC or human-in-the-loop study was conducted. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in the context of interpretation of data.

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

• No standalone (algorithm only) performance study was done as this is a physical medical device, not a software algorithm.

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

• The "ground truth" for the non-clinical testing was based on engineering standards and specifications (e.g., ISO 14801 for fatigue testing, ANSI/AAMI/ISO 17665-1/2 for sterilization), and the design input/specifications for the abutment and its compatibility with implant systems. For biocompatibility, it relied on the "ground truth" established for previously cleared Argen and Sterngold devices with similar materials.

8. The sample size for the training set

• This question is not applicable. There is no software algorithm or AI model being "trained" for this physical device.

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

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

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ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:

| IMPLANT BRAND
NAME | PLATFORM | Manufacturer | Implant Trade
Name | Implant
Line/Connection | Implant
Diameter |
|---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------|
| Nobel Biocare Replace
Select | 6.0mm | Nobel Biocare USA | Nobel Replace
Tapered
Conical
Connection | Nobel Replace
Internal Conical
Connection WP | 6.0mm |
| Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Straumann Bone Level | 3.3mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
NC | 3.3mm |
| Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
RC | 4.1, 4.8mm |
| Straumann Synocta | 4.8mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
4.8mm RN (Reg.
Neck) | 4.8, 6.5mm |
| Straumann Synocta | 6.5mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
6.5mm (Wide
Neck) | 4.8, 6.5mm |
| Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed | OsseoSpeed
Internal Conical
Connection RP | 3.6, 4.2, 4.8mm |
| Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed
Plus | OsseoSpeed Plus
Internal Conical
Connection RP | 3.0, 3.5, 4.0, 4.5,
5.0mm |

Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.

Minimum and Maximum Gingival Height is 0-6mm

Minimum diameter at abutment/implant interface is 3.5mm to interface base

Maximum length of abutment from abutment/implant interface is 12.5mm

Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.

Minimum wall thickness at abutment/implant interface is 0.65mm

Maximal angle in relationship to the long axis of implant is 30°

The available range of diameters and connection type is summarized on the table below:

This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.

Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.

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: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
• Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.

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. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.

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

Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and 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 device is a dental implant abutment, not an AI diagnostic tool.

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

Not applicable. This device is a physical medical device, 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 based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

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

Not applicable. This is a physical medical device.

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ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.

The ArgenIS Titanium Abutments are compatible with the following implant systems:

Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient-specific form.

Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°

The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.

The provided document is a 510(k) premarket notification for the ArgenIS Titanium Abutments. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or by presenting detailed performance metrics against predefined benchmarks.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or a detailed breakdown of test sets, ground truth establishment, or clinical study types (MRMC, standalone).

However, I can extract the information that is present and explain why other details are not available in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and direct "reported device performance" values for clinical outcomes. Instead, it relies on bench testing to show functionality and equivalence to predicate devices. The "performance data" section focuses on demonstrating mechanical integrity and compatibility.

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

The document mentions "worst case scenario samples" for fatigue testing (one implant size from each proposed platform) but does not provide a specific numerical sample size for this or other bench tests. It refers to "non-clinical test data," indicating these are laboratory-based tests, not human subject data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is not a clinical study.

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

This information is not applicable. The "ground truth" for the non-clinical bench testing would be established by engineering specifications, material standards, and regulatory requirements (e.g., ISO 14801). There is no mention of human experts establishing a "ground truth" in the diagnostic or clinical sense for this type of device.

4. Adjudication Method for the Test Set

This is not applicable as the testing described is technical bench testing, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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

No, an MRMC comparative effectiveness study was not done. These are typically for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. This document is for a physical medical device (dental abutment) and focuses on mechanical and physical properties.

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

This is not directly applicable. A "standalone" study usually refers to the performance of an algorithm or AI without human intervention. While the device itself functions without continuous human interaction once implanted, the performance evaluation here is on its manufactured properties and compatibility, not an "algorithm's" diagnostic accuracy. The bench tests described could be considered "standalone" in that they evaluate the device itself.

7. The Type of Ground Truth Used

For the described performance testing (tolerance analysis, functional fit checks, fatigue testing), the "ground truth" would be engineering specifications, material properties, and regulatory standards (e.g., ISO 14801 for fatigue testing, or dimensional specifications for fit). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.

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

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

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ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

The provided text describes a 510(k) premarket notification for a dental ceramic device, ArgenZ Esthetic Plus, and its claim of substantial equivalence to a predicate device, BruxZir Anterior (K143330). The information does not describe a study involving an AI device and human readers, but rather a comparison of physical and biological properties of two ceramic materials.

Therefore, the following points address the questions based on the provided document, acknowledging that most questions related to AI studies are not applicable.

1. Table of acceptance criteria and the reported device performance

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

The document describes material testing for dental ceramics, not a clinical study involving a test set of data. The testing was conducted on samples of the ArgenZ Esthetic Plus material to ensure it meets ISO standards and is comparable to the predicate device. Details on the number of samples or the country of origin for these material tests are not provided. The tests would be prospective in the sense that they are performed on the manufactured material to evaluate its properties.

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 question is not applicable to the provided document. The ground truth for this device relates to the physical and biological properties of the ceramic material, which are established through standardized laboratory testing (e.g., ISO 6872:2008) rather than expert consensus on a test set of patient data.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews of data, which is not the nature of the information presented here.

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 question is not applicable. The document describes a medical device in the dental ceramic category, not an AI device.

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

This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI algorithm.

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

The ground truth for the ArgenZ Esthetic Plus device and its predicate is based on standardized laboratory testing and material specifications as defined by ISO 6872:2008 for dental ceramics, as well as the known properties of the base material (Yttrium-stabilized Zirconia) in medical applications. This includes measurements of flexural strength, density, coefficient of thermal expansion, and confirmation of biocompatibility.

8. The sample size for the training set

This question is not applicable. As the document concerns a physical material, there is no "training set" in the context of an AI model. The material's properties are inherent to its composition and manufacturing process.

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

This question is not applicable. There is no training set for an AI model. The "ground truth" for the material's properties is established through adherence to international standards for dental ceramics (ISO 6872:2008) and well-documented scientific principles of material science and biocompatibility.

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ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.

The provided regulatory submission describes a 510(k) premarket notification for the ARGEN PMMA device, a polymethylmethacrylate (PMMA) disc for dental CAD/CAM systems. The submission asserts substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the information required to directly answer some of the questions (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods) is not explicitly detailed in the provided documents. The approach taken is a comparison of material properties to demonstrate equivalence.

Here's a breakdown based on the available information:

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

Since this is a substantial equivalence submission, "acceptance criteria" are implied by demonstrating that the ARGEN PMMA device has comparable physical and chemical properties and biological performance to its predicate devices. The reported "performance" is that these properties are similar or identical.

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: Not explicitly stated. The submission relies on comparative data and general material properties rather than a specific test set for performance validation in the typical sense of a diagnostic or therapeutic device study.
• Data Provenance: Not explicitly stated. The tests conducted (ASTM F895-84:1984, ISO 10993.5:1999, US Pharmacopeia XXVIII) are international standards, suggesting data would be generated according to these protocols, but the specific origins are not mentioned.

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/Not mentioned. The submission is not a clinical study involving expert interpretation of results, but rather a materials science comparison.

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

• Not applicable/Not mentioned. No expert adjudication process is described for this type of 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 device is a dental material (PMMA discs), not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.

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

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

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

• The "ground truth" for this submission is based on established material science standards and properties of the predicate devices. The claim is that ARGEN PMMA meets these established material characteristics. For biological performance, it refers to the non-toxic nature of PMMAresin, which is a widely accepted characteristic in dentistry.

8. The sample size for the training set

• Not applicable. This type of submission does not involve a "training set" in the context of machine learning or statistical modeling.

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

• Not applicable, as there is no "training set" in this context.

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