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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, intended to be placed into dental implants to provide support for dental prosthetic restorations.

Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.

IPD Dental Implant Abutments includes the following categories of dental abutment designs:

• Titanium base (Interface) abutments (INC3D);
• Multi-Unit abutments (MUA);
• Overdenture Abutments (PSD);
• Temporary Abutments (PP);
• Healing Abutments (TC).

The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:

• Ti Screw (TT): Used during restoration fabrication.
• TiN Screw (TTN): Used in finished restorations, with TiN coating.
• TPA Screw (TPA): Used in finished angulated restorations, with TiN coating.

The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implant for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

The purpose of this submission is to expand IPD Dental Implant Abutments offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)

Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment and cemented to the zirconia superstructure.

The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory.

The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials:
Scanner: 3D Scanner D850.
Design Software: 3Shape Abutment Designer Software, K151455.
Zirconia Material: DD Bio Z, K142987.
Milling machine/Brand: Dental Concept System Model: DC1 Milling System.
Cement: Multilink® Automix, K123397.

Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows:
Minimum gingival height: 1.5 mm
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm (1)
Maximum gingival height: 6.0 mm
Maximum angulation of the final abutment 30° (2)

The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

The provided FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.

The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
• Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
• Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
  • Sterilization validation (ISO 17665-1)
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
  • Reverse engineering and dimensional analysis for compatibility
  • Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
  • Static and dynamic fatigue testing (ISO 14801)
  • Modified Surfaces Information
  • MRI safety review

Conclusion:

The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this text.

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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 purpose of this submission is to expand the Indications for Use of the LOCATOR® Angled Abutment product line (K243272 & K233587) by adding compatibility of existing abutments with various new dental implant systems from Implant Direct and Biohorizons. Additionally, the submission expands the Indications for Use of the product line with a modified version of the predicate device shown to be compatible with the Implant Logistics Implant-One Series 300 and Series 400 Implant Systems. The LOCATOR Angled Abutment is designed and intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla, as cleared to be used with LOCATOR FIXED (K213391) and LOCATOR Attachment Systems (K072878).

The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated in various abutment heights, identical to the predicate device. 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 and K243272. The abutments 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, identical to the predicate device.

The provided document is an FDA 510(k) clearance letter for the LOCATOR® Angled Abutment, K250721. This document primarily focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use, rather than detailing a study that proves the device meets specific performance acceptance criteria for a new clinical application.

Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment (which are typical for AI/ML device clearances or those requiring extensive clinical performance data) is not present in this type of regulatory submission for a dental implant abutment.

However, based on the information provided, I can construct a table for the acceptance criteria and reported "performance" in the context of this 510(k) submission, which is primarily a demonstration of mechanical compatibility and safety rather than a clinical efficacy study.

Here's an interpretation based on the provided text:

Overview of Device Performance and Acceptance Criteria (as per the 510(k) Submission)

The LOCATOR® Angled Abutment (K250721) is a dental implant abutment. The "study" proving it meets acceptance criteria in this context is a series of non-clinical tests and engineering analyses demonstrating its compatibility with various dental implant systems and confirming its mechanical properties and biocompatibility are substantially equivalent to previously cleared devices. The acceptance criteria are implicitly met by showing conformance to established standards and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the conventional sense for a clinical trial. For physical testing (fatigue, packaging), standard engineering test specimen numbers would have been used, but these are not detailed. For material and biocompatibility, existing data was leveraged. Functional compatibility was primarily through engineering analysis.
• Data Provenance: The data comes from in-vitro non-clinical testing and engineering analyses conducted by the manufacturer, Zest Anchors, LLC, or leveraged from previous submissions (K243272, K233587, K213391, K072878, K173701, K102822). The origin is the manufacturer's internal testing and regulatory submissions. The nature of these tests is "retrospective" in the sense that results from previous validated tests (e.g., K233587 for TiN coating, K072878 for biocompatibility) are being applied ("leveraged") to demonstrate equivalence for the current device, implying these tests were performed in the past.

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

• Number of Experts: Not applicable. For this type of device (dental abutment) and submission (510(k) for expanded compatibility), "ground truth" is established through engineering specifications, material standards, and validated physical/mechanical testing protocols (e.g., ISO, ASTM). It does not involve human expert consensus on clinical images or patient outcomes.
• Qualifications of Experts: N/A, as the "ground truth" is based on objective, standardized physical and material properties, confirmed by engineering analysis.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring human adjudication of results. Engineering and laboratory tests have objective pass/fail criteria or conformance to standards.

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

• MRMC Study Done? No. MRMC studies are typically for AI/ML devices where human readers interpret diagnostic images. This device is a physical dental implant component.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study Done? No. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's "performance" and "acceptance" is based on:
  • Engineering specifications and drawings: Ensuring physical compatibility (e.g., fit with implants).
  • International Standards: Conformance to mechanical testing standards (ISO 14801:2016 for fatigue), material standards (ASTM F136), and biocompatibility standards (ISO 10993 series).
  • Predicate device performance: Demonstrating that the subject device's design, materials, and performance characteristics are "identical" or "substantially equivalent" to previously cleared devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• How Ground Truth Established: Not applicable.

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NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Temporary prosthetic components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses.

NUVENTUS NV.C™ FINAL PROSTHETIC
NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.

The NUVENTUS NV.C™ Prosthetic Components product portfolio consists of NUVENTUS NV.C™ Healing Components, NUVENTUS NV.C™ Temporary Prosthetic Components, NUVENTUS NV.C™ Multi-unit Abutments, and NUVENTUS NV.C™ Final Prosthetic. NUVENTUS NV.C™ Prosthetic Components product portfolio are intended to be used with the NUVENTUS NV.C™ Dental Implant System (K233081).

NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ Healing Components may come in different designs, either with cap or screw portion machined as one piece or with an integrated occlusal screw. Different shapes, transmucosal heights are available. Healing components are components that cover the implant or abutment platform and prevent tissue overgrowth during the healing phase of the implant. The threaded portion of the healing components fits inside the internal threads of the implant or abutment, while the head of the healing components covers the top surface of the implant (the implant head) or abutment.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
The NUVENTUS NV.C™ Temporary Prosthetic Components line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are premanufactured dental abutments used for restoration of NUVENTUS NV.C™ Dental Implant of different diameters and lengths. The Multi-unit Abutments are available in NP and RP platform sizes; 0°, 17° and 30° angulations; various transmucosal heights and hexagonal index orientations. Multi-unit Abutments are co-packed with abutment carrier and screw. The abutments are delivered sterile for immediate use.

NUVENTUS NV.C™ FINAL PROSTHETIC
The NUVENTUS NV.C™ Final Prosthetic line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The provided FDA 510(k) Clearance Letter for NUVENTUS NV.C™ Prosthetic Components does NOT describe a device that uses AI or machine learning. It describes conventional prosthetic components for dental implants.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data, including:

• MRI Safety: Evaluation of components in an MR environment based on scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance.
• Sterilization Validation:
  • Gamma irradiation validation (25 kGy dose) for sterile components according to ISO 11137-1 and ISO 11137-2.
  • Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 (

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The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.

This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.

However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
• Sample sizes used for the test set and data provenance (not applicable for this type of device)
• Number of experts used to establish ground truth and qualifications (not applicable)
• Adjudication method (not applicable)
• MRMC comparative effectiveness study (not applicable)
• Standalone (algorithm-only) performance (not applicable)
• Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
• Sample size for the training set (not applicable)
• How the ground truth for the training set was established (not applicable)

The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:

• Sterilization validation testing (ISO 17665-1 & 2)
• Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
  • Cytotoxicity
  • Oral mucosa irritation
  • Skin sensitization
  • Acute systemic toxicity
  • Subchronic systemic toxicity
  • Bacterial reverse mutation
• Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
• TiN coating tests (F1044, F1147, F1160)
• Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.

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Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Compatibility Table

Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm.

The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws.

The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.

All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.

The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are:

• Minimum Zirconia Wall Thickness – 0.5 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia)
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician.

The overall design parameters for the Titanium Blank customized abutments are:

• Minimum Wall Thickness – 0.75 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations.

Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration.

All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The provided FDA 510(k) Clearance Letter for Sherlock Dental Implant Abutment does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical data reviewed by the FDA for clearance. However, it does not detail specific acceptance criteria or an associated study demonstrating compliance with those criteria.

The "Performance Data" section lists several types of non-clinical data submitted, such as static and fatigue testing according to ISO 14801, a reverse engineering study, biocompatibility testing, cleaning and sterilization validation, and an MRI review. These are the studies performed to support the substantial equivalence claim, but the FDA letter does not specify quantitative acceptance criteria for these tests nor does it report specific performance outcomes that directly address such criteria.

Therefore, I cannot populate the requested table or provide details for points 1-9 based solely on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study against predefined acceptance criteria.

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MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.

All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.

MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.

The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).

The design parameters for L-LINK patient-specific abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
• Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
• Maximum angle – 20°

All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.

MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.

The design parameters for PREFIT patient-specific abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
• Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
• Maximum angle – 30°

The provided document is a 510(k) clearance letter for a dental device, specifically dental implant abutments. It details the device's administrative information, predicate devices, indications for use, subject device description, and performance data used to demonstrate substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm. The performance data section refers to non-clinical analyses, such as MR compatibility, sterilization validation, biocompatibility, mechanical properties testing, reverse engineering, and static/dynamic compression-bending testing conforming to ISO 14801. These are standard tests for mechanical dental devices, not AI/ML performance evaluation.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the given text. The device described, "Mist IC," is a physical dental implant abutment, not an artificial intelligence/machine learning (AI/ML) powered medical device.

To directly answer your prompt based on the provided text, the following information is missing or not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical and material performance testing for a physical device, not AI/ML performance metrics like sensitivity, specificity, or AUC against defined acceptance criteria for an AI algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set. The document refers to testing of physical components (OEM implants, abutments, screws, subject device constructs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/ML ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the physical properties and mechanical integrity verified by engineering standards (e.g., ISO 14801).
8. The sample size for the training set: Not applicable. No AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable. No AI/ML training set mentioned.

The document focuses solely on the substantial equivalence of the "Mist IC" dental implant abutments to legally marketed predicate devices based on design, materials, manufacturing, and conventional mechanical/material performance testing.

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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center.

Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only.

These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface.

The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP).

All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician.

The design parameters for zirconia superstructures to be used with Geo Multibase abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm)
• Maximum gingival height – 5.0 mm
• Maximum angle – 0° (straight only)

All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections.

All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are:

• Minimum wall thickness – 0.65 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 5.0 mm
• Maximum angle – 30°

Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

The provided text is a 510(k) clearance letter for a dental implant abutment, not an AI/ML medical device where performance characteristics like sensitivity, specificity, or reader studies are typically discussed.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use (IFU) comparison: Showing that the intended use of the Geo Abutment is the same as already cleared devices (supporting prosthetic devices in edentulous patients, compatible with various implants).
• Technological characteristics comparison: Detailing similarities in design, materials (titanium alloy, TiN coating, zirconia for superstructures), manufacturing processes (CAD/CAM, milling center), mechanical properties, and sterilization methods.
• Non-clinical performance data: This section lists types of tests conducted (e.g., mechanical testing per ISO 14801, shear/tension testing per ASTM F1044/F1147, sterilization validation per ISO 17665-1/2, biocompatibility per ISO 10993-5/12) to ensure the device meets safety and performance standards equivalent to the predicate. However, it does not provide acceptance criteria or specific numerical results from these tests. It only states that these tests were done to "demonstrate that the subject devices... have sufficient strength for the intended use" and "characterize the mechanical properties."

Therefore, based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically part of the test reports submitted to the FDA, but not usually summarized in the publicly available 510(k) clearance letter or summary in this level of detail (i.e., the specific pass/fail thresholds and the measured values for each test). The document only states what was tested and the conclusion that it demonstrated "sufficient strength."
2. Sample sizes used for the test set and the data provenance: This information is not present in the 510(k) summary. These details would be in the specific test protocols and reports.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as this is a physical device, not an AI/ML diagnostic aid requiring human expert annotation for ground truth.
4. Adjudication method for the test set: Not applicable for this type of device.
5. MRMC comparative effectiveness study: Not applicable for a physical dental abutment. This is typically for AI/ML diagnostic devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable for a physical device.
7. The type of ground truth used: For a physical device like a dental abutment, "ground truth" relates to material properties, mechanical strength, dimensional accuracy, and biocompatibility, as demonstrated through engineering tests and material characterization, not clinical outcomes or expert consensus in an AI sense. The document refers to ISO and ASTM standards, which define the test methods and what constitutes acceptable performance (the "ground truth" for material and mechanical properties).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates substantial equivalence for a physical dental device through comparison to predicate devices and adherence to established engineering and material standards, rather than through clinical study formats typically seen for AI/ML diagnostic tools.

To answer your question, if this were an AI/ML device document, the "acceptance criteria" and "reported device performance" would typically be found in sections describing performance metrics like:

• Sensitivity, Specificity, Accuracy
• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC)
• Positive Predictive Value (PPV), Negative Predictive Value (NPV)
• F-score or Dice coefficient (for segmentation tasks)
• Comparison to a "clinical standard of care" or "expert performance."

And the "study that proves the device meets the acceptance criteria" would be a clinical validation study (often a retrospective or prospective reader study or a standalone algorithm performance study) with clearly defined ground truth, reader qualifications, and statistical analysis. None of these elements are present because the device is a physical dental abutment.

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Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant Systems:

All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.

For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.

All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:

(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure

The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.

Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.

Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":

Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.

Regarding the specific questions about an AI/ML context:

1. A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
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 is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
7. The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.

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Custom Abutment AS Ti:
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

ASC Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes new digital abutments to the Neodent Implant System (GM, NGM and HS prosthetic interfaces). The abutments proposed on this submission are identical to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above, being the only difference between them the introduction of a new angled channel solution. This submission intends to expand the portfolio of Neodent Implant System. The Custom Abutments AS Ti are composed of a unique body with two different regions: the upper region, which is the customizable portion, and the end region presents the prosthetic interface that fits with the implant, which does not allow customization. They must be sent to a Straumann Validated Milling

This document describes the Neodent Implant System - Custom Abutments and its FDA 510(k) clearance (K250614). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for a novel AI/software device.

Based on the provided text, the device is a physical medical device (dental implant abutment) and not an AI/software device. Therefore, the questions related to AI/software performance studies, such as sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "Performance Testing" section primarily describes bench testing (dynamic fatigue and torsion tests), biocompatibility testing, and sterilization validation, which are standard for physical medical devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format typically seen for performance metrics of a diagnostic device. Instead, it describes general compliance with standards and the determination of "not a new worst case" for dynamic fatigue.

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

• Sample Size for Bench Testing (Dynamic Fatigue and Torsion): Not
  explicitly stated. The document mentions "a worst case analysis determined that the subject devices are not a new worst case compared to those devices tested for the primary predicate." This implies that testing was performed on a sufficient number of samples to make this determination, likely following the requirements of ISO 14801.
• Data Provenance: Not explicitly stated, but these are typically laboratory-based bench tests performed by the manufacturer or a contracted testing facility.

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

• Not Applicable. This is a physical device, and the testing involves objective measurements (e.g., force, torque, material properties) rather than expert interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable. As above, the tests are objective physical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI-assisted diagnostic or decision support system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical device. While it involves digital design using CAD/CAM software, the 'device' itself is the physical abutment, and its performance is evaluated through physical and material tests, not software algorithm performance.

7. The Type of Ground Truth Used

• Physical/Material Standards and Engineering Specifications. For dynamic fatigue and torsion tests, the "ground truth" or acceptance criteria are derived from established engineering principles, material properties (ASTM F136 for titanium alloy), and international standards (ISO 14801). For biocompatibility, it's compliance with ISO 10993 series.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no "training set" in the context of machine learning or AI models.

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

• Not Applicable. As above, no training set for an AI/ML model for this physical device.

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