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The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.

This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.

Here's an attempt to address the request based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

• "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
  | - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
  | - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate).
• Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
• Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
  | Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating,"
• "Biocompatibility testing of the PEEK Healing Caps."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Sterilization (ISO 17665-1, -2) | - "Sterilization testing."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p

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Medentika TiBase CAD/CAM 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.

Medentika PreFace CAD/CAM 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.

The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.

TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.

Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.

The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.

The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:

• Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
• Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
• Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
• Biocompatibility testing: For cytotoxicity according to ISO 10993-5.

The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).

In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.

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Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.

Microdent Genius Implant System is comprised of dental implants and prosthetic components. Microdent Genius dental implants are internal connection endosseous implants machined titanium that can be used with deferred load or immediate load techniques. If sufficient bone depth is available the implant can be inserted sub-crestal. Microdent Genius Implant is recommended to place 2mm sub-crestal position.

The implant has a connection formed by six grooves extending radially around the axis of the implant to provide a precise position of the abutment.

Microdent Genius Implants are provided with blasted surface.

The implants are supplied sterile and the abutments are provided non-sterile.

Implants are also offered in various diameters and length.

Contained various Microdent Genius abutments made of Ti-6AL 4-V-ELI alloy.
The abutments Conical, Angled and Mini Capitel are used for cemented and screw-retained restorations.

A Cover screw protects the inner configuration of the implant and supplied sterile with the implant.
Healing abutment to shape the soft tissue during the healing phase.
The Retention Screws are used for securing the abutments to the implant.

Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.

All abutments include appropriate features and dimensions to mate with Microdent Genius implants.

The provided document is a 510(k) Premarket Notification for the Microdent Genius Implant System, dating back to 2015. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the information provided is primarily a comparison to predicate devices and describes non-clinical testing for compliance with standards, rather than a study designed to meet specific acceptance criteria for performance as would be seen for complex diagnostic or AI devices.

Based on the provided text, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a dental implant system (a medical device, not an AI/diagnostic device), the "acceptance criteria" are compliance with established ISO standards and demonstration of substantial equivalence to a predicate device. The "device performance" is therefore shown through successful completion of these non-clinical tests and the comparison of characteristics.

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test. The document refers to "bench testing" and "analyses" without providing specific numbers of implants or abutments tested for each non-clinical performance test.
   • Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting on manufactured devices, not using patient data. The manufacturer (Implant Microdent Systems) is located in Spain.

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

   • This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices (especially AI/imaging devices) where human experts determine the true condition of a patient based on clinical data. For this dental implant system, the "truth" is determined by compliance with engineering and material standards and performance under simulated conditions.

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

   • Not applicable. Adjudication methods are typically employed in studies where human readers are interpreting data, and disagreements need to be resolved. This document details non-clinical laboratory testing.

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:

   • No. This is a dental implant system, not a diagnostic or AI device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to this submission.

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

   • No. This is a dental implant system, not an algorithm or AI device.

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

   • The "ground truth" for this device's performance is established by engineering standards and material specifications (e.g., ISO standards). Tests were performed according to these standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility), and the device's adherence to these predefined criteria serves as the "truth." There is no clinical "truth" from patients or expert consensus in this non-clinical submission.

7. The sample size for the training set:

   • This information is not applicable. There is no "training set" in the context of a dental implant system's 510(k) submission. This concept is relevant for AI/machine learning models.

8. 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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The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.

The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.

The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics.

The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.

This document does not contain the information required to answer your request. The provided text is a 510(k) summary for dental abutments, which outlines the device description, intended use, and substantial equivalence to predicate devices, but does not describe any studies with acceptance criteria or performance metrics in the way you've outlined.

This submission is for a medical device (Cercon® Abutments) and, based on the provided text, the FDA classified it as substantially equivalent to existing predicate devices. This typically means that the device's technological characteristics and intended use are similar enough to already-approved devices that extensive new clinical studies with defined acceptance criteria and performance reporting might not have been necessary for the 510(k) clearance process itself. The summary states that "We believe that the prior use of the components of the CERCON® ABUTMENTS in legally marketed devices, the provided, and the biocompatibility history support the safety and effectiveness of the CERCON® ABUTMENTS for the indicated uses." This suggests reliance on existing data for similar components, rather than new performance studies.

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Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm
• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• Ankylos 3.5, 4.5, 5.5, 7.0 mm

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm -
• -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• . Ankylos 3.5, 4.5, 5.5, 7.0 mm
  The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
  Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

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