Search Results

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

The Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1mm and 4.8 mm) and WN (4.8 mm) sizes.

Inclusive® Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.

This document describes a 510(k) premarket notification for Inclusive® Titanium Abutments compatible with the Straumann synOcta Implant System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission might.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not explicitly present in the provided text. The document employs a different regulatory strategy, relying on demonstrating that the new device is as safe and effective as devices already on the market through comparison and non-clinical testing.

Here's an analysis based on the available information, noting where specific requested details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of explicit acceptance criteria with numerical targets and reported performance in the way a clinical trial or performance study would. Instead, substantial equivalence is demonstrated through a comparison table of attributes (Indications for Use, Dimensions, Connection, Sterility, Material, Abutment Angle, Abutment Seat, Screw Seat, Anatomical Site, Construction) where the proposed device is shown to be similar to legally marketed predicate devices.

The "reported device performance" is summarized by the outcome of non-clinical testing, which aimed to show implant-to-abutment compatibility and substantial equivalence, rather than meeting specific performance metrics against pre-defined acceptance criteria.

Summary of Comparative Attributes (from pages 6-7):

Study Details:

The study referenced is a non-clinical "Performance Data" study (Section G).

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 for Test Set: Not explicitly stated. The document refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a limited number of samples chosen to represent the most challenging conditions rather than a statistically powered test set sample size.
• Data Provenance: Not specified, but generally, such non-clinical testing would be conducted in a laboratory setting by the manufacturer (Prismatik Dentalcraft, Inc.), which is based in Irvine, California, USA. It is prospective testing designed to evaluate the physical properties of newly manufactured components.

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)

• Number of Experts & Qualifications: Not applicable for this type of non-clinical, substantial equivalence submission. Ground truth in this context typically refers to objective material properties, mechanical integrity, and compatibility, which are established through standardized engineering tests rather than expert consensus on medical images or clinical outcomes.

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

• Adjudication Method: Not applicable. Non-clinical mechanical testing does not involve adjudication. Results are typically determined by direct measurement and adherence to specifications or established test methods (e.g., ASTM 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

• MRMC Study: No. This submission is for a physical medical device (dental abutments), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be objective measurements derived from mechanical tests, such as fatigue strength, static load failure, and dimensional compatibility, compared against established engineering standards (e.g., ASTM F136 for material, and potentially other ISO or FDA recognized standards for dental implants/abutments). The document explicitly states testing was "in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.

The Stern AC Dental Implant System is only intended for use with straight abutments.

The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.

The provided document is a 510(k) Premarket Notification for the Stern AC Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or quantifiable performance metrics for the Stern AC Dental Implant System. Instead, the "performance" demonstrated is that the device is "substantially equivalent" to predicate devices and "performs appropriately for the proposed indications for use." The performance testing mentioned is primarily non-clinical, focusing on material and design characteristics.

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

• Test Set Sample Size: Not applicable in the context of this document. The submission is based on demonstrating substantial equivalence through comparison of design, materials, and non-clinical performance to existing cleared devices, not on a clinical "test set" of patients or a defined dataset with ground truth for algorithm evaluation.
• Data Provenance: The data provided primarily stems from the manufacturer's internal design specifications, material characterization, manufacturing process descriptions, and comparisons to predicate devices. It is entirely retrospective in the sense that it relies on existing knowledge and data for predicate devices and internal validation of the manufacturing processes and material properties of the new device. There is no mention of patient data, clinical trials, or external datasets.

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

• Not applicable. There is no "test set" in the sense of a dataset requiring expert ground truth establishment for algorithm evaluation. The "ground truth" for this submission is FDA's existing clearances for predicate devices and established standards for dental implant materials and design.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" 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 document describes a traditional medical device (dental implant) submission, not an AI/software as a medical device (SaMD) submission. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is established by:
  • Regulatory Precedent: The FDA's previous clearance of the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
  • Industry Standards: Adherence to guidance documents like "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
  • Material Science Principles: The properties of CP Titanium grade 4 and the known performance of specific surface treatments (blasted with aluminum oxide particles and acid etched).
  • Engineering Design Principles: The design features like self-tapping threads, flared neck, and internal connections are evaluated against known engineering principles for dental implants.
  • Laboratory Testing: SEM photographs for blasting residue removal and sterilization validation results.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. There is no "training set" or ground truth for such a set.

Ask a specific question about this device

The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.

The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.

"The provided text does not contain information about studies related to AI/ML device performance or acceptance criteria in the typical sense for such devices. The document is a 510(k) summary for a dental implant system (Stern IC Dental Implant System).

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This document
   focuses on substantial equivalence to predicate devices, not performance criteria
   against a defined benchmark.
2. Sample size used for the test set and the data provenance: Not applicable as
   there is no discussion of a test set for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the
   qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if
   so, what was the effect size of how much human readers improve with AI vs without
   AI assistance: Not applicable, as this is not an AI/ML device.
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 (expert consensus, pathology, outcomes data,
   etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details the substantial equivalence of the Stern IC Dental Implant
System to predicate devices based on material, design, surface treatment, and intended
use. The study described is a non-clinical testing to demonstrate appropriate
performance for the proposed indications for use, following "Guidance for Industry and
FDA Staff - Class 11 Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments."

Specifically, the non-clinical testing involved:

• SEM photographs: To show removal of all residue of the blasting material from the surface.
• Surface chemical analysis: To confirm no contaminants are left on the surface (conducted on the final device).

It states that fatigue testing was not required because design and technological features are substantially equivalent to predicate devices. The conclusion is based on an analysis of intended use, material, design, and performance being substantially equivalent to the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Straumann ITI Dental Implant System (K012757))."

Ask a specific question about this device

The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.

The Essential Cone implants are fitted with an internal octagonal conical connection.

The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.

Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.

8mm Implants are not indicated for use as unitary implants and for immediate load.

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.

Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.

The relevant sections of the document are primarily focused on:

• Device Identification: Name, manufacturer, contact.
• Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
• Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
• Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
• Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.

Ask a specific question about this device