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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.

Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.

The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

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The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.

Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.

To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.

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The IS-III HActive Fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This device has connection between the upper prosthesis and the internal hex. Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating. It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant). Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm. IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.

The provided text describes the submission of a new dental implant device (IS-III HActive Fixture) to the FDA for substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI/ML device submission would.

The document focuses on demonstrating that the new device is as safe and effective as previously approved devices by comparing their characteristics (intended use, materials, design, etc.) and presenting results from non-clinical testing. This type of submission (510(k)) does not typically include clinical studies with acceptance criteria for device performance as would be seen for AI/ML-driven diagnostics.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a formal table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it refers to meeting criteria of various engineering and biocompatibility standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical bench testing and biocompatibility assessments, not a diagnostic test on a test set of human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for diagnostic performance is not established in this type of submission. Performance is based on material properties and mechanical integrity.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

For the non-clinical testing, the "ground truth" or reference was based on established industry standards (ISO, ASTM, ANSI/AAMI, USP) and FDA guidance documents for mechanical, material, and biological properties of medical devices.

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.

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The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.

Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:

The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that guide healing tissue.

Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.

The provided text describes a 510(k) premarket notification for the "Anatotemp Anatomic Dental Implant Healing Abutment." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a clinical study with a specific test set, ground truth, and expert adjudication as one would find for a novel AI/imaging device.

Therefore, many of the requested criteria cannot be directly extracted from this document, as the regulatory pathway for this device (a dental implant healing abutment) does not involve the same type of performance evaluation as, for instance, an AI-powered diagnostic imaging system.

This document primarily relies on non-clinical testing (biocompatibility, chemical characterization, packaging, sterilization, shelf-life, and reverse engineering analysis) and comparison to a predicate device to establish substantial equivalence. It explicitly states that "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device."

Here's an attempt to address your points based on the provided text, highlighting where information is not applicable or not present for this type of device submission:

Acceptance Criteria and Device Performance for the Anatotemp Anatomic Dental Implant Healing Abutment

Since this is a 510(k) submission for a physical medical device (dental implant healing abutment) demonstrating substantial equivalence to a predicate, the "acceptance criteria" and "device performance" are typically related to material properties, biocompatibility, sterility, and functional equivalence, rather than diagnostic accuracy metrics as would be seen for an AI system. The study described is a series of non-clinical tests and a comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and characteristics required for demonstrating substantial equivalence to the predicate device, as well as the successful completion of the non-clinical tests. Performance is reported as meeting these standards.

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

• Test Set Sample Size: For the non-clinical testing, specific sample sizes are not explicitly stated for each test (e.g., number of animals for biocompatibility, number of packages/devices for sterilization/packaging). The document mentions "sample of the OEM implants were measured" for reverse engineering. This is not a "test set" in the context of an AI study.
• Data Provenance: Not applicable for this type of submission. The data is generated from internal company testing and contract lab testing, not patient data from a specific country or collected retrospectively/prospectively in a clinical setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device does not use human "experts" to establish a ground truth for performance evaluation in the way an AI diagnostic imaging system would. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM, USP) and laboratory protocols.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the context of human interpretation or diagnostic accuracy for this device.

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

• No. The document explicitly states: "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device..." An MRMC study is a type of clinical study, typically for diagnostic devices or AI assistance in interpretation.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission type is based on:
  • Regulatory Standards: Compliance with ISO, ASTM, and USP standards for biocompatibility, sterility, packaging, etc.
  • Engineering Specifications: Data derived from reverse engineering analysis of OEM implant systems to ensure compatibility.
  • Predicate Device Equivalence: The characteristics and performance of the legally marketed predicate device (Contour Healer).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no "training set."

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

• Not applicable. There is no "training set."

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JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate 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.

JDentalCare®implant system is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare®implants are machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.

However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.

2. Sample Size for Test Set and Data Provenance

This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.

• Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
• Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.

4. Adjudication Method

Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.

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

Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device, which refers to its performance and safety, is established through:

• Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
• Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
• Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
• Comparison to predicate devices with an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.

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

Not applicable.

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