Search Results

TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)

All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.

TruBase S 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. The system also includes a TruBase S Screw for fixation to the implant body.

TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.

They also feature:

• . cylindrical shape
• hexagonal indexing at the apical end of the connection ●
• indexing guide in the cementable portion for coping fitting ●

CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.

The provided document describes a 510(k) premarket notification for a dental implant abutment, TruBase S. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness. As such, the information you're looking for regarding AI-specific criteria, clinical study designs, human reader performance, or training set details associated with an AI-driven device is largely not present in this document.

However, I can extract the acceptance criteria and study details relevant to the mechanical performance and substantial equivalence of this medical device.

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

The acceptance criteria for mechanical performance are implicitly set by compliance with ISO 14801:2016 for fatigue testing. The document states that the test results "met the criteria of the standard." For design parameters, the acceptance criteria are substantial equivalence to the predicate device, K201197.

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 does not specify a distinct "test set" in the context of an AI-driven device or clinical study. The testing performed was non-clinical mechanical performance testing on physical devices and based on technical specifications and design parameters.

• Sample Size: For the fatigue testing, the document mentions "worst-case constructs" were subjected to testing, and "the fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient." However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data originates from internal non-clinical testing conducted by the manufacturer or accredited labs for mechanical and material properties. No country of origin is specified for these tests. The nature of these tests is prospective in the sense that they are conducted specifically for the submission, but they are not clinical studies.

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. The device is a physical dental implant abutment, not an AI device that requires expert ground truth labeling for image analysis or diagnostic purposes. The "ground truth" for its performance is established through adherence to engineering standards (ISO 14801) and material specifications (ASTM F 136).

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of data (e.g., medical images) is compared with an AI's output, often involving multiple experts to resolve discrepancies. This device's evaluation relies on objective mechanical and material testing, not human interpretation or 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

This information is not applicable. This device is a physical dental implant abutment and is not an AI-driven diagnostic or assistive device that would participate in an MRMC study.

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

This information is not applicable. This device is a physical dental implant component, not an algorithm.

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

The "ground truth" for this medical device is based on:

• Material Specifications: Adherence to ASTM F 136 for titanium alloy.
• Engineering Standards: Compliance with ISO 14801:2016 for fatigue testing, and ISO 17665-1/2 and ANSI/AAMI ST79 for sterilization.
• Biocompatibility Standards: Compliance with ISO 10993 series.
• Dimensional and Design Parameters: Matching the design limits established by the predicate device and compatible OEM implant lines.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for this physical medical device. Manufacturing processes are based on established engineering principles and quality control, not machine learning training.

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

This information is not applicable, as there is no training set for this physical medical device.

Ask a specific question about this device

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. It is compatible with the following systems:
· Zimmer 3.1mmD Dental Implant System (K142082)

• · Screw Vent® and Tapered Screw Vent® (K013227)
• · Nobel Active 3.0 (K102436)
• · Nobel Active Internal Connection Implant (K071370)
  All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
· Zimmer 3.1mmD Dental Implant System (K142082)

• · Screw Vent® and Tapered Screw Vent® (K013227)
  TruBase S is intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screwretained restorations. The patient-specific abutment screws 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 the 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 S 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 S 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 (Zimmer 3.1mmD Dental Implant System: 2.9mm and Screw Vent® and Tapered Screw Vent®: 3.5, 4.5, 5.7mm). They also feature:

• . cylindrical shape
• . hexagonal indexing at the apical end of the connection
• . indexing guide in the cementable portion for coping fitting
  CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.
  TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.

The provided text is a 510(k) summary for a dental device, TruAbutment DS and TruBase S. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design specifications, materials, and non-clinical testing (mechanical and biocompatibility).

This document does not contain information about studies involving human-in-the-loop performance, expert ground truth establishment, or clinical effectiveness studies in the context of AI/ML device performance. The "acceptance criteria" discussed are related to the mechanical properties and biocompatibility of the physical dental abutment and base, rather than the performance of an AI/ML algorithm.

Therefore, many of the requested points, such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document as they are not relevant to the type of device and testing described.

However, I can provide information based on the mechanical and material testing criteria that are present.

Here's an analysis of the provided text in relation to your request, with a clear indication of what information is not available:

Information Pertaining to Device Acceptance (Mechanical/Biocompatibility):

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

   The document describes design limitations and states that non-clinical testing (fatigue and biocompatibility) met the criteria of the standard, demonstrating substantial equivalence. It does not provide specific numerical performance results for the acceptance criteria, but rather states whether the device "met the criteria of the standard" (ISO 14801:2016 for fatigue, ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010 for sterilization, and ISO 10993 series for biocompatibility).

   For TruAbutment DS:

   Design Parameter	Design Limit (Acceptance Criteria)	Reported Performance (Qualitative)
   Abutment Angle	0~25°	Met design limit
   Cuff Height	0.5~6.0mm	Met design limit
   Diameter at abutment/implant interface	Ø3.5mm~Ø8.0mm	Met design limit
   Minimum Thickness	0.4 mm	Met design limit
   Length of abutment post	4~7 mm	Met design limit

   For TruBase S (Zirconia Superstructure):

   Design Parameter	Design Limit (Acceptance Criteria)	Reported Performance (Qualitative)
   Abutment Angle	0~15°	Met design limit
   Cuff Height	0.5~5 mm	Met design limit
   Diameter at abutment/implant interface	Ø5.0mm~Ø8.0mm	Met design limit
   Minimum Thickness	0.4 mm	Met design limit
   Length of abutment post	4~6 mm	Met design limit

   Non-Clinical Testing:

   Acceptance Criteria (Standard)	Reported Performance
   Fatigue Test (ISO 14801:2016)	"The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."
   End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010)	"The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device."
   Biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010)	"The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device."

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

   • Sample Size: Not explicitly stated for specific tests (e.g., how many abutments were fatigued). The document mentions "worst-case constructs" were subjected to testing.
   • Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory testing) rather than human subject data. The studies are retrospective as they leverage data from previous 510(k) clearances (K152559).

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

   • Not applicable. The "ground truth" here is based on engineering standards (e.g., ISO 14801 for mechanical properties, ISO 10993 for biocompatibility) and direct physical measurements, not expert human interpretation of medical images or clinical outcomes.

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

   • Not applicable. This relates to human expert review and consensus, which is not part of the physical and mechanical testing described.

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 physical dental implant component, not an AI/ML diagnostic or assistive imaging device.

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

   • Not applicable. This is not an AI/ML algorithm. It's a medical device that is CAD/CAM manufactured.

7. The type of ground truth used:

   • For mechanical performance: Compliance with ISO 14801:2016 standard. This involves objective physical measurements and material science.
   • For sterilization: Compliance with ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010 standards.
   • For biocompatibility: Compliance with ISO 10993-5:2009, ISO 10993-10:2010 standards.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for manufacturing is implied through the "TruAbutment-validated milling center."

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

   • Not applicable. As above, no computational "training set" is described. The manufacturing process relies on validated design parameters and material specifications.

In summary, this 510(k) submission successfully demonstrates substantial equivalence based on engineering design parameters, material properties, and adherence to established mechanical and biological safety standards for a physical dental implant component. It does not involve AI/ML technology or associated human-in-the-loop performance studies.

Ask a specific question about this device

The TruBase S 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 serew-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• · Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
  All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

TruBase S 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 S 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 (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:

• cylindrical shape
• hexagonal indexing at the apical end of the connection
• indexing guide in the cementable portion for coping fitting
  The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
  TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.

The provided text describes a 510(k) premarket notification for a dental implant abutment, TruBase S, and details the non-clinical testing performed to establish its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical trial or a full performance study with human subjects, AI systems, or ground truth established by experts as would be typical for an AI/ML medical device.

The information primarily focuses on mechanical testing, material equivalence, and compatibility, which are acceptance criteria for this type of medical device's safety and effectiveness.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present in the document.

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

The document doesn't present a table of acceptance criteria with specific numerical performance metrics in the way you might expect for an AI/ML device (e.g., sensitivity, specificity). Instead, it states that tests met "the criteria of the standard" or "demonstrated substantial equivalence."

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 refers to "non-clinical testing" for the TruBase S and leverages results from predicate devices for other tests. These are likely laboratory or bench tests on physical samples rather than patient data.

• Sample size for test set: Not explicitly stated as "test set" in the context of patient data. For mechanical fatigue testing, "worst-case scenario (smallest diameter with maximum angulation)" implies a specific configuration of a few physical samples, but the exact number isn't provided.
• Data provenance: Not applicable in the context of patient data. The tests are non-clinical, likely conducted in a lab environment.

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 a passive dental component, and its evaluation relies on engineering standards and mechanical testing, not a clinical interpretation by human experts establishing ground truth from patient data.

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

Not applicable. There's no clinical imaging or diagnostic data requiring expert 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. This document does not pertain to an AI/ML device that assists human readers.

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

No. This is not an AI/ML algorithm. The "software" mentioned is CAD/CAM software used for design and manufacturing, not an AI for diagnosis or treatment planning. The device itself is a physical dental abutment.

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

The "ground truth" for this type of device is established by adherence to recognized engineering standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 for biocompatibility) and dimensional compatibility with existing implant systems. There is no biological or expert consensus "ground truth" as you would find for diagnostic devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device