Search Results

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes the regulatory clearance for the TruAbutment DS and TruBase devices, citing substantial equivalence to predicate devices, and includes details about non-clinical testing. However, it does not contain information about a study proving device performance against specific acceptance criteria for AI or algorithmic performance. The studies mentioned are focused on mechanical and biocompatibility testing of the physical dental implant abutments.

Therefore, for aspects related to AI/algorithmic performance, sample sizes, expert ground truth, adjudication, and MRMC studies, the information is not present in the provided document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The document describes "Design Limitations" for both TruAbutment DS and TruBase, which can be interpreted as design acceptance criteria. It also references compatibility and mechanical performance tests.

TruAbutment DS Design Limitations / Reported Performance:

TruBase / Zirconia Superstructure Design Limitations / Reported Performance:

Mechanical Performance:

• Acceptance Criteria: Met the criteria of ISO 14801:2016 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments."
• Reported Device Performance: "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

Sterilization Validation:

• Acceptance Criteria: Met the criteria of ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010.
• Reported Device Performance: Achieved through end-user moist steam sterilization.

Biocompatibility:

• Acceptance Criteria: Met the criteria of ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Reported Device Performance: Not explicitly stated as "passed" for the subject device, but mentioned it was leveraged from predicate device testing and supports substantial equivalence.

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

• Test Set Sample Size: For mechanical testing (ISO 14801), "worst-case constructs" were subjected to static compression and compression fatigue testing for each compatible OEM implant line. The exact number of samples is not specified.
• Data Provenance: Not specified; the context implies laboratory testing. The document does not refer to real-world patient data for performance evaluation in the context of AI.

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

Not applicable. The tests performed are non-clinical (mechanical, sterilization, biocompatibility) of physical devices, not assessments requiring expert interpretation of data or images.

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

Not applicable for non-clinical, physical device testing.

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. No AI component is described in the performance evaluation section for either TruAbutment DS or TruBase. The software mentioned (3Shape Abutment Designer Software) is for CAD/CAM design, which is a tool for designing the physical device, not an AI for diagnosis or interpretation that would involve human readers.

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

Not applicable. As noted above, the device itself is a physical dental abutment, and its design process involves CAD/CAM software, not a standalone AI algorithm for medical decision-making or image analysis.

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

• Mechanical Testing: Ground truth is established by the specified ISO standards (ISO 14801) and FDA guidance, defining acceptable force and fatigue limits for dental implant systems.
• Dimensional Analysis: Ground truth is against design specifications and reverse engineering of OEM implant-to-abutment connections.
• Sterilization: Ground truth is against ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 standards for sterilization efficacy.
• Biocompatibility: Ground truth is against ISO 10993 standards for biological safety.

8. The sample size for the training set

Not applicable. The document describes a physical medical device and its manufacturing process, not an AI/ML algorithm that requires a training set. The CAD/CAM software aids in design, but the document does not detail its internal development or any associated training sets.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

This 510(k) premarket notification for the Atlantis™ Abutment in Zirconia for Astra Implants does not include a study proving device performance against acceptance criteria in the way typically seen for diagnostic or AI-driven devices.

Instead, this submission is a claim of substantial equivalence to previously cleared predicate devices based on material, design, and intended use. The "acceptance criteria" here relate more to meeting established standards for biocompatibility and mechanical properties rather than performance in a clinical or diagnostic setting.

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on provided text)

Further Information Based on the Document:

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

   • N/A. No "test set" in the context of performance data (e.g., clinical outcomes, diagnostic accuracy) is described. The submission relies on a comparison to predicate devices, material standards, and intended use.

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

   • N/A. No ground truth establishment by experts for a test set is described.

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

   • N/A. No adjudication method for a test set is described.

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:

   • No. This device is a dental implant abutment, not a diagnostic imaging device or an AI-driven tool for human readers. Therefore, an MRMC study is not applicable.

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

   • N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

   • N/A. For this type of 510(k) submission, the "ground truth" is largely established by adherence to recognized material standards (ISO, ASTM) and the established performance/safety profile of the predicate devices. There is no "ground truth" in the sense of clinical outcomes or pathology data specifically collected for this submission to prove its performance.

7. The sample size for the training set:

   • N/A. This is a physical medical device, not a machine learning model. There is no training set mentioned or implied.

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

   • N/A. As above, no training set is relevant here.

Summary of the Study/Evaluation described in the document:

The document describes a substantial equivalence claim rather than a "study" in the traditional sense of a clinical trial or performance evaluation against specific metrics. The "study" implicitly performed by the manufacturer, and reviewed by the FDA, involved:

• Comparison to Predicate Devices: The Atlantis™ Abutment in Zirconia for Astra Implants was compared to three predicate devices (K070833, K053384, K024111) to demonstrate equivalence in intended use, material, design, and performance. This is the primary method of evaluation for this 510(k)
• Material Characterization: The biocompatibility and composition of the materials (Y-TZP and Ti-6A1-V ELI) were likely verified against established international standards (ISO 6972, ISO 13356, ASTM F-136).
• Design Specifications: The design would have been reviewed to ensure it met specifications compatible with the Astra Tech OsseoSpeed™ implants and to verify that any design changes from predicate devices did not raise new questions of safety or effectiveness. This would include considerations for angled abutments and implant diameters.

The FDA's review and clearance signify their agreement that the provided information supports the claim of substantial equivalence, meaning the device is as safe and effective as the legally marketed predicate devices.

Ask a specific question about this device