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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 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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