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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device