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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 Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

The provided document is a 510(k) summary for a medical device called "Surgical Drills." It is a regulatory submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria, ground truth, experts, and training/test sets are not applicable here.

However, I can extract and present the acceptance criteria and the studies performed to demonstrate the device's conformance, as detailed in the document.

Acceptance Criteria and Device Performance for Surgical Drills (Non-AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each test in the way you would typically see for an AI/ML study. Instead, it refers to "worst-case drills" for corrosion and distribution testing, and "all three groups" for performance testing (referring to the subject device and predicate device, likely with multiple samples per group).

• Provenance: This is a regulatory submission for a medical device. The data provenance is from the manufacturing company, Implant Direct Sybron Manufacturing, LLC, specifically from their non-clinical testing performed to support the 510(k) submission. These are prospective tests conducted by the manufacturer.

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

Not applicable. This is a physical medical device (surgical drills), not an AI/ML system that requires expert-established ground truth for classification or prediction. The "ground truth" for these tests is based on objective measurements and established industry standards (e.g., ISO, ASTM, AAMI).

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML study requiring expert adjudication of results. The results are based on objective physical and chemical testing.

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, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization.
• Industry Standards: e.g., ASTM F1089 for corrosion testing, AAMI TIR30 and TIR12 for cleaning validation, ASTM D4169-16 for distribution testing.
• Objective Measurements: e.g., axial drilling force measurements, visual/SEM assessment for performance, TOC and protein levels for cleaning, absence of visible corrosion.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical surgical device.

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Legacy3 6mm Length consists of two-picce implants for one-stage on 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.

The Legacy3 6mm length implants 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.

The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.

The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work.

The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy.

The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.

The provided text describes a 510(k) submission for the "Legacy3 6mm Length Implants." This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. Therefore, the "acceptance criteria" are typically the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" refers to the non-clinical performance testing conducted to support this claim of substantial equivalence.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance testing, primarily mechanical and physical characterization, to demonstrate substantial equivalence.

• Sample Size for Test Set: Specific sample sizes for each mechanical test (static compression bending, fatigue, driving torque, screw torque) are not explicitly stated in the provided text. However, the testing was done for "worst-case devices," implying a selection of implants representing the range of sizes or configurations most likely to fail.
• Data Provenance: The data provenance is from laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, which is based in Calabasas Hills, CA, USA. This is an experimental/testing type of data. It is not patient data (retrospective or prospective).

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)

This section is not applicable as the ground truth was established through non-clinical engineering and laboratory testing in accordance with recognized standards (FDA guidance, ISO 14801, ISO 11137-2, AAMI TIR-33). Ground truth in this context refers to the measured performance against established engineering benchmarks rather than expert consensus on medical images or clinical outcomes.

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

This is not applicable as there was no human reader interpretation or clinical adjudication involved in the non-clinical performance testing. The "ground truth" was derived from direct physical and chemical measurements against defined engineering specifications and regulatory standards.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (dental implant), not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

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

The "ground truth" for demonstrating substantial equivalence for the Legacy3 6mm Length Implants was based on:

• Engineering Specifications and Standardized Test Results: Compliance with established mechanical and physical performance benchmarks defined by FDA guidance ("Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (ISO 14801 for mechanical testing, ISO 11137-2 and AAMI TIR-33 for sterilization).
• Comparative Analysis: Demonstrating that the new device's performance (e.g., mechanical strength, surface area, pull-out strength) is equivalent to or better than that of already legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

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