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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.

Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:

1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:

Study Details (for a mechanical device):

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

   • Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
   • The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
   • The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).

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 as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.

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 mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

   • Not applicable. This device is a mechanical abutment, not an algorithm.

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

   • The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set exists for this type of device.

In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.

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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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IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.

IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:

• Hybrid abutments for single-tooth restorations -
• -Hybrid abutment crowns for restorations

IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.

The provided document describes the IPS e.max® Press Abutment Solutions for Nobel Biocare (K124008), a dental device. The study demonstrating its acceptance is primarily a mechanical fatigue test under dynamic loading.

Here's the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific quantitative acceptance criteria of ISO 14801:2007 (e.g., number of cycles at a certain load without failure) are not explicitly stated in the provided text, only that the device "meets" them and is "substantially equivalent" to the predicate. The performance is reported as meeting the ISO standard and achieving substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "Fatigue tests... were completed using Nobel Biocare Replace Select Tapered TiU NP implant, Ø=3,5 mm, I=11.5mm and Snappy abutment 4.0 NobelReplace NP 0.75." This indicates at least one setup was tested, but the total number of samples or repetitions is not specified.
• Data Provenance: Not specified. It's likely an in-house laboratory study.

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

• Not applicable. This study is a mechanical performance test, not a clinical study requiring human experts for ground truth. The "ground truth" is established by adherence to the ISO 14801:2007 standard.

4. Adjudication Method for the Test Set:

• Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.

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

• No. The document explicitly states: "Clinical Studies: Clinical testing is not required and has not been performed." Therefore, an MRMC study was not conducted.

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

• Not applicable. This is a physical dental device, not a software algorithm. The "standalone performance" is its mechanical performance in a laboratory setting, which was indeed evaluated.

7. The Type of Ground Truth Used:

• Standardized Mechanical Performance Metrics: The ground truth for this device is based on the performance requirements outlined in the ISO 14801:2007 standard for "Dynamic fatigue performance applicable to endosseous implant systems."

8. The Sample Size for the Training Set:

• Not applicable. As this is a mechanical device, there is no "training set" in the context of an algorithm or AI.

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

• Not applicable. As there is no training set for this device.

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