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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.

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 Abuttnent 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 abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile 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 document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

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

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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 "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

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

This question is not applicable as there is no human interpretation or diagnostic "test set" that would require 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 question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

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

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

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

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

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

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

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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 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 Abuttnent 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 according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is delivered non-sterile 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 regulatory clearance of a dental abutment, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the Elos Accurate® Customized Abutment to previously cleared predicate devices. The non-clinical testing described is for the physical dental device itself (e.g., fatigue testing, biocompatibility, sterilization validation) and validation of the digital dentistry workflow for designing and manufacturing the abutment.

There is no mention of:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A test set, training set, or data provenance for an AI/ML algorithm.
• Experts establishing ground truth for AI/ML performance.
• Adjudication methods for AI/ML.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Ground truth types related to AI/ML (e.g., pathology for image classification).

The "digital dentistry workflow validation" mentioned refers to the software (3Shape Abutment Designer Software) that provides design limits for the abutment, not an AI/ML algorithm that performs a diagnostic or predictive task. It essentially ensures the software's constraints prevent users from designing abutments outside safe parameters.

Therefore, I cannot extract the requested information about AI/ML device acceptance criteria and study details from the provided document. The document is for a traditional medical device (dental abutment) and its manufacturing workflow, not an AI/ML enabled device.

Ask a specific question about this device

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.

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 document, a 510(k) Premarket Notification summary for the Elos Accurate® Customized Abutment, outlines the device's indications for use, technological characteristics, and non-clinical testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information typically found in an acceptance criteria and performance study for a medical device that uses an algorithm or AI. This document is for a physical dental abutment, not a device that relies on an algorithm or AI for its function.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets acceptance criteria related to an AI/algorithm-based device. The original document does not offer data points for:

• A table of acceptance criteria and reported device performance (in the context of algorithm performance)
• Sample size for a test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data)
• Sample size for a training set
• How ground truth for a training set was established

The "testing" mentioned in the document (fatigue testing, biocompatibility testing, dimensional analysis) is for the physical material and design of the abutment, not for an algorithm's performance.

Ask a specific question about this device

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.

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 a medical device, the Elos Accurate® Customized Abutment, and its 510(k) submission to the FDA. However, the document does not contain information regarding objective acceptance criteria (e.g., performance metrics with defined thresholds), nor does it detail a study that proves the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K190299) based on similar intended use, operating principle, design, materials, and sterilization processes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth details, as these are not present in the provided text.

The information that is available regarding testing is non-clinical and aims to show similarity and safety compared to the predicate device, rather than meeting specific performance thresholds against a defined clinical outcome.

Here's a summary of the non-clinical testing performed, which serves as the evidence for substantial equivalence:

Non-Clinical Testing Information (as provided):

• Type of Testing:
  • Engineering and dimensional analysis of original manufacturers' components (abutments, implants & abutment screws) for determination of compatibility.
  • Fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004.
  • Biocompatibility testing for cytotoxicity according to ISO 10993-5.
• Tests Included for Biocompatibility:
  • Non-coated prosthetic screw (representative for subject device, tested on primary predicate device K190299).
  • Medicarb coated prosthetic screw (representative for subject device, tested on reference predicate device K171799).
  • Elos Accurate® Customized Abutment (representative for subject devices, tested on reference predicate device K171799).
• Sterilization: The primary predicate device was tested according to ISO 17665-1 & ISO 17665-2, demonstrating a Sterility Assurance Level (SAL) of $10^{-6}$. No additional testing was deemed necessary for the subject device.

Missing Information (Not provided in the document):

• Specific quantitative acceptance criteria for performance metrics.
• A clinical study designed to demonstrate performance against such criteria.
• Sample size used for a test set (as no such test set for performance evaluation is described).
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Effect size of human reader improvement with AI vs. without AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to report on a clinical performance study with predefined acceptance criteria.

Ask a specific question about this device

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 following implant systems:

Ref. No. Platform compatibility Implant diameter
AB-BRA411213-US Nobel Biocare® / Brånemark® RP 3.75 mm & 4 mm
AB-BRA351213-US Nobel Biocare® / Brånemark® NP 3.3 mm
AB-BRA511213-US Nobel Biocare® / Brånemark® WP 5 mm

All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an 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 Brånemark® endosseous 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 non-sterile 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 document is a 510(k) summary for a medical device (Elos Accurate® Customized Abutment). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, the requested information, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria with specific performance metrics, sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not fully available in this type of regulatory document.

However, I can extract the information related to the non-clinical testing performed to support substantial equivalence, which serves a similar function in demonstrating device safety and effectiveness.

Here's an organized breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the non-clinical testing aims to demonstrate that the subject device's mechanical, material, and biological properties are equivalent to or better than the predicate device and comply with relevant international standards and FDA guidance.

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

This information is not provided in the document. For engineering and biocompatibility tests, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM), but specific numbers are not disclosed here. The document describes tests on the device itself, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data.

4. Adjudication Method

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm or AI assistance requiring human reader evaluation.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

This information is not applicable as the document relates to a physical medical device (dental abutment), not an algorithm.

7. Type of Ground Truth Used

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

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665-1 & -2 for sterilization).
• Compliance with FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
• Physical measurements and engineering analysis compared against established specifications and predicate devices.

8. Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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