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NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) Premarket Notification letter. This type of document is a submission seeking regulatory clearance, not a standalone study report. As such, it outlines the basis for demonstrating substantial equivalence to a predicate device, which includes non-clinical testing. It does not typically contain detailed acceptance criteria and performance data for a study proving a device meets those criteria in the way a clinical trial report or a comprehensive validation study would.

The document primarily focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. It refers to non-clinical tests that were performed, but does not present the specific acceptance criteria or the numerical results of those tests in a "performance table" format.

Therefore, many of the requested points below cannot be fully extracted from this document, as it's not the type of report that contains that level of detail for acceptance criteria and specific study outcomes. I will highlight what can be inferred or directly stated from the provided text, and what cannot.

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a detailed engineering validation report or a clinical study. Instead, it states that "non-clinical tests demonstrate that the device is substantial equivalent."

The document mentions several tests and standards the device was subjected to:

• Packaging system performance testing: per ASTM D4169. (Specific acceptance criteria and reported performance not detailed.)
• Dynamic loading testing: conducted according to ISO 14801 and FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)). (Specific acceptance criteria and reported performance not detailed.)
• Magnetic Resonance compatibility testing: according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Status: "MR Conditional." (This is a performance outcome, but the specific metrics and acceptance thresholds for each ASTM standard are not detailed.)
• Verification of biocompatibility: in accordance with ISO 10993-1. (The conclusion is that "no new issues regarding biocompatibility were raised," implying acceptance, but specific criteria and test results not detailed.)
• End user cleaning and sterilization validation: in accordance with ISO 17665-1. (Implied acceptance, but specific criteria and results not detailed.)

The "acceptance criteria" here are generally referred to as meeting the requirements of the standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is summarized as favorable results sufficient for substantial equivalence determination.

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

• Sample sizes: Not specified in the provided text for any of the non-clinical tests mentioned (packaging, dynamic loading, MR compatibility, biocompatibility, sterilization validation).
• Data provenance: Not explicitly stated (e.g., country of origin). The testing is non-clinical/bench testing, not patient data. It is implied to be internal testing by the manufacturer, Nobel Biocare AB (Sweden).
• Retrospective or prospective: N/A, as these are non-clinical/bench tests, not clinical studies involving patient data.

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

• Applicability: This question is not directly applicable to the type of non-clinical, bench testing described for the NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for AI/ML device evaluations, particularly in diagnostics. This document refers to physical device testing (mechanical, biocompatibility, etc.).

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

• Applicability: Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses for establishing "ground truth," which is not the nature of the non-clinical tests described here.

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

• Applicability: Not applicable. This device is a dental abutment and screw, not an AI/ML-enabled diagnostic device for image interpretation. Therefore, no MRMC study or AI assistance evaluation would have been performed.

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

• Applicability: Not applicable. See point 5. This is a physical medical device, not a standalone algorithm.

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

• Applicability: The concept of "ground truth" as typically applied in AI/ML validation (e.g., for diagnostic accuracy) does not directly apply to the non-clinical device testing described. For these tests, the "ground truth" is typically defined by the specified parameters and performance requirements of the relevant international standards (e.g., ISO 14801 for dynamic loading, ISO 10993-1 for biocompatibility). The devices are expected to meet the performance criteria defined by these standards.

8. The sample size for the training set

• Applicability: Not applicable. This refers to the training of an AI/ML algorithm. The document describes a physical medical device.

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

• Applicability: Not applicable. See point 8.

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AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• · Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
• · Implant Direct Legacy2(K192221) 3.0
• · Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
• · Nobelactive Wide Platform (Wp) (K133731) WP 5.5
• · TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• · Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
   • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

2. 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 is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

   • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

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:

   • Not applicable. This is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

   • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

   • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

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

   • Not applicable for the same reason as above.

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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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N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.

Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.

Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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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.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with:

• · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
• NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
• NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
• NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
• Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0

The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.

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

• Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
• Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.

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

• Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
• Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
• Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
• Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.

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

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.

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Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: (list of compatible implants and abutments follows in the document)

Atlantis suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The subject Atlantis suprastructures include new compatible interfaces of the currently marketed Atlantis suprastructures made by milling (K163350) or additive manufacturing techniques (K163398) for the following abutments and implants: (list of compatible implants and abutments follows in the document). The design of the subject device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the Atlantis suprastructures are fabricated using additive manufacturing (AM) to produce a customized, patient-specific device. The Atlantis suprastructures subject of this bundled premarket notification are fabricated by milling or by additive manufacturing techniques.

The milled Atlantis suprastructures are composed of commercially pure titanium (CPTi) or cobalt chrome alloy and are available in following design types: Bar, Bridge, Hybrid and 2 in 1. Additional design limitations regarding minimum required segment cross-section, maximum span between implants and maximum cantilever extension, have been introduced for Atlantis suprastructures made by milling.

Atlantis suprastructures made by additive manufacturing are provided as Bridge and Hybrid types with optional mechanical retention (pin or cell retention) on the surface. The manufacturing of the Bridges and Hybrids of the Atlantis suprastructures by an additive manufacturing technique start from a titanium alloy and a cobalt-chrome alloy in powder form.

Milled variants of the subject Atlantis® suprastructures are offered in versions composed of unalloyed titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and cobalt chromium alloy (CoCr) conforming to ISO 22674 (Dentistry – Metallic materials for fixed and removable restorations and appliances). Variants of the subject Atlantis® suprastructures which are fabricated utilizing additive manufacturing are manufactured using titanium alloy powder or cobalt chromium alloy powder conforming to ISO 22674 (Dentistrv – Metallic materials for fixed and removable restorations and appliances).

Fixation screws for use with the subject Atlantis® suprastructures are composed of titanium alloy confirming to ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications).

Screws are available for all compatible implants and abutments to screw the Atlantis suprastructures into the implant or onto the abutment.

Labeling is modified by providing a separate compatibility chart which lists all implants and abutments compatible with the Atlantis suprastructures.

This FDA 510(k) summary for the Dentsply Sirona Atlantis® suprastructures does not describe a clinical study for acceptance criteria. Instead, it argues for substantial equivalence to existing predicate devices based on non-clinical performance data and a comparison of indications for use, design, manufacturing techniques, and materials.

Here's an analysis of the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on the equivalency to previously cleared devices. Therefore, explicit "acceptance criteria" in the sense of predefined thresholds for a new study are not presented. Instead, the performance is demonstrated through comparisons to the predicate devices and by referencing a previous fatigue test.

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

The document mentions "cross-sectional material analysis" and "geometric measurement data and statistical compatibility analysis." However, it does not provide specific sample sizes for these analyses. The data provenance is implied to be internal testing conducted by Dentsply Sirona or its subsidiaries, and it's non-clinical. There is no mention of country of origin for this testing data.

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

Not applicable. This device's clearance is based on non-clinical engineering and material testing, and substantial equivalence to existing devices, not a clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is a dental implant suprastructure, not an imaging AI device where MRMC studies are typically performed.

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

No, this is a physical medical device. The "algorithm" aspect refers to the CAD design process, but the testing focuses on the resulting physical product's performance and compatibility, not an AI algorithm's diagnostic performance.

7. The Type of Ground Truth Used:

For the evaluation of the new compatible interfaces and materials, the "ground truth" is defined by:

• Engineering specifications and dimensional accuracy.
• Material property standards (ASTM F67, F136, ISO 22674).
• Performance standards, particularly ISO 14801 for fatigue testing.
• Comparison to the established performance of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set for an AI algorithm. The CAD design uses pre-programmed libraries and patient-specific scans, but "training set" in the context of machine learning is not relevant here.

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

Not applicable, as there is no "training set" in the machine learning sense described for this device. The design process is CAD-based, utilizing established engineering principles and material science.

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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1.

All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.

This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).

Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

This document is a 510(k) Premarket Notification from the FDA regarding the "Elos Accurate® Hybrid Base" dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information required to directly answer some of your questions, particularly those related to the performance study design for an AI/ML-based medical device (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models), is not present in this document. This is because the device in question is a physical dental implant component, not an AI/ML algorithm.

However, I can extract the relevant information regarding the performance data provided for this physical device.

Here's a breakdown based on the provided document:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML device submission would. Instead, it states that substantial equivalence is demonstrated through:

• Biocompatibility evaluation and confirmatory cytotoxicity testing: According to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Dynamic compression-bending testing: According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
• Engineering and dimensional analysis: To confirm compatibility with OEM implant bodies, OEM abutments, and OEM abutment fixation screws.
• Sterilization validation: In accordance with ISO 17665-1 and ISO 17665-2.

Reported Performance/Demonstration:

• "Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility."
• "Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants."
• "The coatings used on selected screws are identical to coatings on previously cleared devices."
• "Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2."
• "Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines... do not affect substantial equivalence. These minor differences... are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing."

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: Not specified for any of the non-clinical tests (biocompatibility, dynamic fatigue, engineering analysis, sterilization). The document indicates "No clinical data were included in this submission," further confirming that there wasn't a "test set" in the context of patient data for AI performance evaluation.
• Data Provenance: Not applicable as it's not clinical data. The tests are laboratory-based.

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 physical component, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.

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

• Not applicable. As above, this is not a diagnostic study 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. No clinical or human-in-the-loop study was conducted or required for this physical device.

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

• Not applicable. This is not an algorithm. The "performance data" refers to the physical and mechanical properties of the dental abutment.

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

• For the non-clinical performance data, the "ground truth" or reference standards are the ISO standards themselves (ISO 10993-5, ISO 14801, ISO 17665-1, ISO 17665-2), and the engineering specifications/dimensions of OEM implant components for compatibility analysis. This is a technical ground truth based on established material science and mechanical engineering principles, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this physical device.

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

• Not applicable. As above, no training set for an AI/ML model.

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The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:

Table 1.
| Elos Accurate Customized
Abutment - Model Type | Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|---------------------------------------------------|-------------------------|---------------------------|-------------------------------|
| AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 |
| AB-NBA30 | Nobel CC 3.0 | 3 | 3 |
| AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 5 |
| AB-NBA60 | Nobel CC WP | 5.1 | 5.5 |
| AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 |
| AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes the Elos Accurate® Customized Abutment, a dental device, and its FDA 510(k) clearance. This document is a regulatory submission, not a study report detailing AI/ML model performance. Therefore, many of the requested criteria related to AI/ML model evaluation are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can provide information based on the device's performance against engineering and material acceptance criteria, as well as the non-clinical testing performed to demonstrate substantial equivalence to its predicate device. This is primarily focused on mechanical and biological compatibility, not AI/driven diagnostic accuracy.

Here's the information derived from the provided text, adapted to the closest relevant categories:

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

For a device like the Elos Accurate® Customized Abutment, acceptance criteria primarily relate to mechanical properties, biocompatibility, and compatibility with implant systems. The "reported device performance" here refers to the aspects that were tested and deemed acceptable through non-clinical testing to establish substantial equivalence.

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

The document does not specify a "test set" in the context of an AI/ML model. The evaluation here is based on non-clinical testing (mechanical, dimensional, and biocompatibility).

• Sample Size: The document does not provide specific numerical sample sizes for the engineering tests (e.g., how many abutments were subjected to fatigue testing). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data comes from non-clinical laboratory testing and engineering analyses performed by or for Elos Medtech Pinol A/S. The country of origin of the data is not explicitly stated, but the company is located in Denmark. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence.

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

This question is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." Ground truth, in this context, would be established by validated measurement techniques, material science principles, and biological testing standards (e.g., ISO standards for mechanical testing and biocompatibility).

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

This is not applicable. "Adjudication method" refers to the process of resolving disagreements among human readers or experts for establishing ground truth in a diagnostic study. For this device, acceptance is based on meeting predefined engineering and biological performance standards through validated 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

This is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device.

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

This is not applicable. This is not an AI algorithm. Its design uses CAD/CAM technology, but the clearance is for the physical abutment itself, not a diagnostic algorithm.

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

For this device, the "ground truth" or basis for acceptance relies on:

• Established engineering standards: e.g., ISO 14801 for fatigue testing of dental implants.
• Biocompatibility standards: e.g., ISO 10993-5 for cytotoxicity.
• Dimensional analysis: Verifying compatibility with specified implant systems.
• Material specifications: Conformance to Titanium Alloy 6Al-4V ELI (medical grade 5).

There is no "expert consensus" in the diagnostic sense or pathology/outcomes data used for device clearance as described in the summary.

8. The sample size for the training set

This is not applicable because there is no AI/ML model for which a "training set" would be used.

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

This is not applicable because there is no AI/ML model for which training set ground truth would be established.

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