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The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

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

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

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

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. 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.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. 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 in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering 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

• This is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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

• This is not applicable. The device is a physical dental component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

URIS Smart Path Implant System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multipleunit restorations. The surface treated is SLA (Sandblasted, Large grit and Acid etched) and is provided sterile. It consists of two implant lines, the Smart Path OMNI Thread and the Smart Path extra aggressive Thread, with corresponding cover screws, healing abutments. The Smart Path implant has a tapered wall with a single thread design. The Smart Path extra aggressive Thread is straight walled with smaller threading at the coronal end, and bigger threading at the apical end.

URIS SP Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of SP Healing Abutment, SP Temporary Abutment, SP Multi-Unit Straight Abutment, SP Multi-Unit Angled Abutment, SP T-L Straight Abutment, URIS SP Base, URIS SP DS, SP Abutment Screw.

Cover screw and healing abutment are anodized in yellow or green or purple.

Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.

URIS SP Base 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. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is a 510(k) Summary for the URIS Smart Path Implant System & Prosthetic. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, which are typically associated with the questions asked.

The document focuses on non-clinical tests to demonstrate substantial equivalence, as is common for dental implants and prosthetics. These tests are primarily related to material properties, sterilization, packaging, and mechanical fatigue.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance/accuracy studies which were explicitly stated as not included: "No clinical data were included in this submission."

Here's a breakdown of what can be extracted and what information is missing:

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

Missing Information (Not present in the provided document):

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical studies with test sets were performed. Non-clinical tests typically report sample sizes per test standard, but these are not detailed here beyond stating "worst-case scenario" for fatigue testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies requiring ground truth establishment were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies requiring adjudication were performed.
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 system, not an AI-powered diagnostic tool, and no clinical studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed.
8. The sample size for the training set: Not applicable, as no AI/machine learning component requiring a training set is described.
9. How the ground truth for the training set was established: Not applicable, as no AI/machine learning component requiring a training set is described.

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SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

SIMDA Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

This FDA 510(k) summary describes a dental device, the SIMDA Abutment. However, it does not include information that directly addresses the specific questions you've asked about acceptance criteria and a study proving a device meets them, particularly for an AI/ML powered device.

Here's why and what information is provided:

The document is a premarket notification for a Class II medical device, specifically dental implant abutments. These are physical components used in dental restorations, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concepts of "acceptance criteria for an AI model," "test set," "ground truth," "MRMC studies," "effect size of human readers with AI assistance," or "standalone algorithm performance" are not applicable to this submission.

The "studies" mentioned are non-clinical (mechanical, biological) tests demonstrating the physical safety and performance of the abutments and their compatibility with existing dental implant systems.

Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the device type:

Device: SIMDA Abutments (K232271)
Device Type: Endosseous Dental Implant Abutment (physical medical device, not AI/ML powered)

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

The document sets design limits and then demonstrates conformity through non-clinical testing. The "acceptance criteria" here are rather design specifications and performance standards for dental abutments.

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 provided. For physical tests (fatigue, biocompatibility, sterilization), sample sizes would typically be determined by the relevant ISO standards.

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. "Ground truth" in the context of AI/ML is not relevant here. The "truth" is established by physical measurement, adherence to material standards, and documented mechanical performance.

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

• Not applicable. Adjudication methods are typically for subjective assessments, whereas these are objective physical tests.

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 is a physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical dental device.

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

• For physical tests, the "ground truth" is defined by the ISO standards and FDA guidance documents to which the device is tested. This includes established methods for fatigue testing, biocompatibility evaluation, and sterilization efficacy. For compatibility, it's about precise dimensional matching and mechanical fit to existing OEM implant systems.

8. The sample size for the training set

• Not applicable. This is a physical dental device, not an AI/ML powered device that requires a "training set."

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

• Not applicable. See point 8.

In summary, this document is for a traditional medical device (dental abutments), and thus the questions formulated for an AI/ML device do not directly apply. The acceptance criteria are based on established engineering and materials standards, and performance is demonstrated through non-clinical laboratory testing rather than clinical or observational studies on diagnostic performance.

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URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

URIS Base 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. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

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

The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

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. Ground truth as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader or AI performance study.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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