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The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile. The Neoss Express Abutment requires no modification and allows for abutment level impression taking. The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Neoss various Titanium Abutments. It details the device's identification, equivalence to predicate devices, description, intended use, technological characteristics, and a discussion of performance testing.

However, the document does not contain the acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the format typically used for AI/ML medical devices. Instead, it refers to general guidelines for dental implant systems and states that the device "fills the recommended requirements."

Therefore, I cannot populate the requested table and answer the study-specific questions as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through design similarities and adherence to general mechanical testing guidelines, rather than presenting specific quantitative performance metrics against defined
acceptance criteria from a clinical or analytical performance study.

Here's a breakdown of what could be provided based on the document and what is missing:

Information Requested	Provided in Document	Missing from Document
1. Table of Acceptance Criteria & Reported Performance	General Statement: "The Neoss Various Titanium Abutment has, where applicable, been tested in accordance to the Guideline (Doc. No. 0043 - Guidance for industri and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004) and the test results show that the abutment fills the recommended requirements."	Specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life, accuracy thresholds) and corresponding measured performance values.
2. Sample Size & Data Provenance (Test Set)	Not applicable, as this is a mechanical device, not an AI/ML diagnostic. The "test set" would typically refer to the number of devices or components tested.	Specific number of abutments or components tested in mechanical testing, and whether the data was from a specific country or retrospective/prospective.
3. Number & Qualifications of Experts (Ground Truth)	Not applicable, as this is a mechanical device, not reliant on expert review for ground truth.	N/A
4. Adjudication Method (Test Set)	Not applicable (no ground truth based on expert review).	N/A
5. MRMC Comparative Effectiveness Study	Not applicable, as this is a mechanical device; an MRMC study is for evaluating human reader performance with and without AI assistance.	N/A
6. Standalone Algorithm Performance	Not applicable, as this is a mechanical device, not an algorithm.	N/A
7. Type of Ground Truth Used	Material/Design-based Ground Truth: Compliance with "design similarities between the predicative device and the devices in this application, since the devices are very similar in terms of material, size, preparation and basic design." Mechanical Performance Ground Truth: Adherence to "recommended requirements" from the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments." This implies physical properties and durability standards.	Specific, detailed physical measurements, stresses, and failure points that define the "ground truth" for mechanical integrity.
8. Sample Size for Training Set	Not applicable, as this is a mechanical device, not an AI/ML algorithm.	N/A
9. How Ground Truth for Training Set was Established	Not applicable, as this is a mechanical device.	N/A

Summary regarding the "study that proves the device meets acceptance criteria":

The document refers to "Mechanical testing requested for Dental Implant Systems" described in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." It states that the device "has, where applicable, been tested in accordance to the Guideline... and the test results show that the abutment fills the recommended requirements."

This statement indicates that a study (mechanical testing) was conducted in accordance with an FDA guidance document, and the results demonstrated compliance with the requirements outlined in that guidance. However, the specific details of that study (e.g., number of units tested, precise tests performed, quantitative results, and the exact "recommended requirements" or acceptance criteria from the guidance document) are not provided in this 510(k) summary. The conclusion of substantial equivalence is based on these tests and design similarities to predicate devices.

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