Search Results

The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.

The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

• SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
• SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
• SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder.

The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies.

The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base:

(1) end user creation of a press-ceramic material by conventional wax-up technique,

(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and

(3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission):

• Ceramic material: ZirCAD Prime (K142233) .
• . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
• . Composite: Kerr Harmonized (K151332)
• Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
• Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
• . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

This document describes a premarket notification for the "SMARTbase Abutment System," a dental implant abutment. The document focuses on demonstrating that the new device is substantially equivalent to existing predicate devices through various performance tests.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format for each test. Instead, it states that "The test results support that the Subject Device met the performance specifications as intended." and "The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent."

However, we can infer the types of performance tests and the general acceptance (i.e., compliance) from the "x. Performance Testing Data" section.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of abutments subjected to fatigue testing).
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a premarket notification for regulatory clearance, the testing would generally be conducted by the manufacturer or a contract research organization on manufactured devices, following established protocols. It is non-clinical testing, meaning it's not performed on patients.

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

This question is not applicable as the document describes non-clinical performance testing for a medical device (dental abutment), not studies involving expert evaluation of diagnostic outputs or ground truth for AI algorithms. The "ground truth" here is defined by engineering standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (like 2+1) are typically used for establishing ground truth in clinical or diagnostic studies involving human interpretation or pathology.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. The document describes non-clinical performance testing of a physical dental abutment and associated design software. It does not involve human readers, cases, or AI assistance in a diagnostic context.

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

For the software component:

• Standalone Performance: Yes, standalone software verification and validation testing was performed for the abutment design library. This testing demonstrated that the software's inherent design restrictions and specifications for creating the top half of the two-piece abutment prevent designs outside allowable limitations and that the design limitations are locked and cannot be modified. This is essentially an "algorithm only" test to ensure the software functions as designed within its specified parameters.

7. The Type of Ground Truth Used

• For Physical Device Performance (Fatigue, MR Compatibility, Biocompatibility, Sterilization, Shipping): The ground truth is based on established international and national standards (e.g., ISO 14801, ISO 10993-1, ISO 17665-1, ASTM F2052, ASTM D4169). Compliance with these standards serves as the "ground truth" for acceptable mechanical, safety, and operational performance.
• For Software Verification & Validation: The ground truth is the defined design limitations and specifications established by the manufacturer for the abutment components. The software's ability to enforce these limitations (preventing designs outside them and locking specifications) constitutes meeting this "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental abutment and associated design software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The "training" for the software is its programmed adherence to design rules and specifications.

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

This question is not applicable for the same reasons as #8. There is no training set mentioned for an AI/ML model. The software's functional parameters are established through engineering design and specifications.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

• . Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
• Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.

The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Zenostar MT ●
• Cement: EMBRACE Wetbond Resin Cement (K071278) ●
• Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
• Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
• . Abutment design software: 3Shape Abutment Designer™ Software (K151455)
• Milling machine: Wieland-Zenotec Select & Zenotec CAM .

The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.

This document describes Implant Direct Sybron Manufacturing, LLC's Legacy™ SMARTBase Abutments, a dental device intended to provide support for prosthetic restorations in partially edentulous patients. The FDA's 510(k) summary provides information on acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate 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 the specific sample sizes used for each non-clinical test (mechanical fatigue, biocompatibility, sterilization validation). However, it mentions that dynamic fatigue testing was performed on "worst-case device configurations" per ISO 14801:2016.

• Test Set Sample Size: Not explicitly stated for each test, but "worst-case device configurations" were used for fatigue testing.
• Data Provenance: The studies are non-clinical (laboratory testing) performed internally by the manufacturer or by third-party labs following international standards (ISO) and FDA guidance. The country of origin of the data is not specified beyond being part of the manufacturer's submission to the FDA. The data is prospective as it was generated specifically for this 510(k) submission.

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

This information is not applicable as the studies are non-clinical, laboratory-based tests for physical, chemical, and biological properties of the device. There is no human "test set" requiring expert ground truth establishment in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical laboratory tests.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product."

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

This question is geared towards AI/software performance. While software validation was performed for the associated CAD/CAM software, it is not an "algorithm only" performance study in the typical sense of AI diagnostics. The software (3Shape Abutment Designer Software) is a design tool for the abutment, not a standalone diagnostic or predictive algorithm. Its validation "ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments." This implies a validation of its function within the design workflow, rather than a standalone performance metric for a decision-making algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical Strength (Fatigue): Ground truth is established by the specified loads and cycles in ISO 14801:2016 and the equivalency standard to the predicate device. The "ground truth" is a pass/fail against these engineering standards.
• Biocompatibility: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards.
• Sterilization Validation: Ground truth is established by achieving a verified sterility assurance level of 10^-6 according to ISO 14947 and ISO 17665-1.
• Software Validation: Ground truth is established by the software's ability to "successfully create abutments employing 3Shape software within established design limitations and specification." This refers to functional correctness and adherence to design parameters.

8. The Sample Size for the Training Set

This document does not describe the development or training of an AI algorithm in the traditional sense, so there is no training set sample size mentioned. The CAD/CAM software mentioned (3Shape Abutment Designer Software) is an off-the-shelf product with an existing design library, not something that appears to have been "trained" by this manufacturer on a specific dataset.

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

As there is no explicit training set for an AI algorithm described for the device itself, this question is not applicable. The software validation relies on the established functional specifications and design limitations of the 3Shape software and Implant Direct's abutment design library.

Ask a specific question about this device

InterActive/SwishActive 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 SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

• Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications.

The provided document describes the FDA's 510(k) clearance for the InterActive SMARTBase Abutments, which is a dental implant component. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI device.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance is not applicable or not present in this regulatory submission for a dental abutment. The submission primarily relies on non-clinical testing to demonstrate that the changes from the predicate device do not negatively impact safety or effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific numerical acceptance criteria and corresponding performance metrics for the SMARTBase abutments in a typical AI/software validation format. Instead, it describes general testing categories and their successful completion.

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

• Test Set Sample Size: Not explicitly stated for each test beyond "worst-case configuration" for mechanical fatigue and "worst case drivers" for screw torque.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based non-clinical testing.

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

• Not Applicable. This type of information is typically for devices involving human interpretation of data (e.g., imaging diagnosis). The current device is a physical dental implant abutment, and its "ground truth" is established through engineering and material testing standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of cases, typically in diagnostic or screening AI applications.

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

• No. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks. The InterActive SMARTBase Abutments are physical devices, not an AI software meant to assist human readers.

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

• Not Applicable in the traditional sense of an AI algorithm. While software is mentioned (3Shape Abutment Designer™ Software), its role is in designing the physical component, not in making a standalone medical decision. The software itself underwent "verification and validation testing" to ensure it adheres to design rules and limitations for the physical device. The device itself (the abutment) does not operate as a standalone algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device revolves around engineering specifications, material properties, and established international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization). The successful completion of these standardized tests serves as the evidence of meeting the necessary performance and safety benchmarks. There is no "expert consensus," "pathology," or "outcomes data" ground truth as would be relevant for a diagnostic or predictive device.

8. The Sample Size for the Training Set:

• Not Applicable. This refers to training data for machine learning models. This device is a physical implant component, not an AI model that requires a training set. The "abutment design library" is an engineering dataset, not a machine learning training set.

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

• Not Applicable. See point 8. The "ground truth" for the design library (if one were to interpret "training set" very loosely for a design context) would be established through engineering design principles, material science, and prior validated designs, ensuring the resulting physical abutments meet functional and safety requirements.

Ask a specific question about this device

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.

GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. 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. The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size. The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).

The provided text describes the 510(k) summary for the GPS® Angled Abutments, detailing their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics (e.g., "Must pass X N of force"). Instead, it confirms that the device meets the "equivalent or higher load" than the primary predicate device when tested according to FDA and ISO standards. The general acceptance criteria are:

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

• Sample Size: The document indicates that testing was performed on "the worst case abutment testing" (InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform) and "the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps." However, it does not provide specific numerical sample sizes (e.g., how many abutments were tested for fatigue).
• Data Provenance: The studies are non-clinical performance data, likely conducted by Implant Direct Sybron Manufacturing, LLC which is located in Thousand Oaks, California, USA. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial. There's no mention of country of origin of data beyond the company's location.

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 document describes non-clinical performance data (mechanical, sterilization, biocompatibility testing) rather than a study requiring expert-established ground truth like image analysis or disease diagnosis.

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

This section is not applicable for the same reason as point 3.

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

This section is not applicable. The document describes a medical device (dental abutment), not an AI diagnostic tool that would involve human readers or AI assistance.

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

This section is not applicable for the same reason as point 5.

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

As mentioned in point 3, the studies are non-clinical performance evaluations. The "ground truth" for these tests are universally accepted scientific and engineering standards:

• Mechanical Testing: ISO 14801 standards for fatigue, and static compression tests. The ground truth is the physical failure or endurance limit of the material under applied forces.
• Sterilization: Sterility assurance level (SAL) of 10-6, as per AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79. The ground truth is the measurable absence of viable microorganisms.
• Biocompatibility: ISO 10993-5 standards for biological evaluation of medical devices. The ground truth is the measurable absence of toxic reaction from the devices.

8. The sample size for the training set

This section is not applicable. The device is a physical medical implant, not an algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

InterActive/SwishActive 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.

Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization.

Compatibility: InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

The 2014 InterActive/SwishActive System is a line extension of the previously cleared Implant Direct Sybron Manufacturing LLC, InterActive/SwishPlus2 Implant System (510K #130572) on December 24th, 2013). The name of the SwishPlus2 implants is changing to SwishActive and the Indications for Use within this submission has been revised from previous submission to only reflect the name change.

In addition, the previously cleared InterActive/SwishActive implants have been tested with NobelActive titanium 30 degree angled abutments to expand the indication for use as the test results show that the InterActive/SwishActive implants are prosthetically compatible with NobelActive NP (Narrow Platform -3.0mm diameter) and NobelActive RP (Regular Platform - 3.4mm diameter) titanium abutments with up to 30 degree angulations.

Furthermore, the InterActive 30 degree abutments have been tested with NobelActive implants to expand the indication for use as the test results show that the InterActive abutments are prosthetically compatible with NobelActive NP (Narrow Platform - 3.0mm diameter) and NobelActive RP (Regular Platform -3.4mm diameter) implants with up to 30 degree angulations.

Lastly, the 2014 InterActive/SwishActive System within this submission offers additional abutments that are intended to provide extra prosthetic options to the implant line. These abutments consist of two categories: (1) GPS straight abutments, and (2) Zirconia straight, angled, and modified Abutments.

GPS abutments are used in attachment-retained, tissue supported restorations where the patient is fully or partially edentulous in the arch to be restored. These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions. These abutments are made from Titanium 6AL-4V ELI with the coronal region having a Titanium Nitride (TiN) coating The TiN coating process was validated through cytotoxict y testing in accordance with ISO 10993-5.

The Straight GPS abutments are a one-piece design secured to the implant having identical interface features as the previously cleared InterActive Ball Abutments (K130572) These abutments are available in 1,2,3,4, 5 and 6mm in height.

Zirconia abutments are intended for use in partially or fully edentulous mandible and maxillae in support of single or multiple unit cement retained restorations. The abutments consist of two pieces, the titanium base and the zirconia top. The Zirconia abutments have identical interface features as the previously cleared devices InterActive Cement Retained Abutments and Titanium Non-Engaging abutments (K130572). The abutments have a titanium base that has hex engaging and non-engaging implant/abutment interface having identical specifications as the previously cleared InterActive titanium abutments (K130572). The abutments have a coronal zirconia portion that is straight, angled, or it can be modified by the company to specific patient needs. The modifications to the top are restricted to minimal requirements: a maximum angle of 30° from the axis of the implant, a minimum wall thickness of 0.4mm, a minimum post height of 4mm, and a minimum cuff height from the interface of 0.7mm which are identical minimal requirements specified in the Instructions For Use for the previously cleared InterActive/SwishPlus2 abutments (K130572). These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 2014 InterActive/SwishActive System.

Acceptance Criteria and Study for the 2014 InterActive/SwishActive System

This device, the 2014 InterActive/SwishActive System, is a line extension of previously cleared dental implants and abutments. The submission focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data, primarily mechanical fatigue testing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Non-Clinical Performance Data" and a later section states "[N/A] Clinical Performance Data". This indicates that the testing was performed on physical device samples, not on a human test set. Therefore, sample sizes for a clinical test set are not applicable here.

• Sample Size for Test Set: Not applicable (non-clinical testing).
• Data Provenance: Not applicable (non-clinical testing).

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

This information is not provided in the document. As the study is non-clinical, involving mechanical, biocompatibility, and sterilization testing, it would typically be conducted by engineers, technicians, and scientists specialized in these fields, following recognized international standards. "Ground truth" in this context refers to established material properties and performance benchmarks rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study is non-clinical. Adjudication methods are typically relevant for clinical studies where subjective assessments or conflicting interpretations of data by human readers or experts need to be resolved.

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

This information is not applicable. The device under review is a dental implant system (implants and abutments), which are physical medical devices. There is no mention of AI integration or human-in-the-loop performance in the context of this 510(k) submission.

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

This information is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on established international standards and validated testing methodologies for mechanical performance (ISO 14801), biocompatibility (ISO 10993-5, -12), and sterilization (ANSI/AAMI ST79, ISO 17665-1/-2). The "ground truth" for equivalence is the performance of the legally marketed predicate devices, which have already demonstrated safety and effectiveness through their own compliance with these standards and clinical use.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant system, not a machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and process validation.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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.

Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

The InterActive/SwishPlus2 Implant System consists of InterActive implant, SwishPlus2 implant, abutments, healing components, and screws for use in one or two-stage placement and restorations.

The InterActive implants are two-stage implants that offer four body diameters (3.2, 3.7, 4.3 and 5.0mm) in six lengths (All 6 thru 16mm except for the 3.2 which is 8-16mm). The SwishPlus2 implant body diameters (3.3, 4.1, 4.8, and 5.7mm) in six lengths (All 6 thru 16mm except for the 3.3mm which is 8-16mm).

The InterActive dental implant is a tapered screw-type endosseous with an external thread configuration consisting of double-lead threads over the body of the implant and 2mm of quadruple lead mini-threads near the coronal portion of the implant. The implant body features an even taper from the apical along its body and a straight walled coronal aspect. The implants offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface.

The SwishPlus2 dental implant is a screw-type endosseous with an external thread configuration consisting of single lead threads over the body of the implant and 2mm of micro-grooves near the coronal portion of the implant. The implant body features an even taper at the apical end and a straight wall coronal aspect. The SwishPlus2 (two-stage) implant offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface diameters of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface.

The InterActive/ SwishPlus2 implants are available with two surface coatings: SBM Blast and HA Coating.

Here's an analysis of the acceptance criteria and supporting studies for the InterActive/SwishPlus2 Implant System, based on the provided 510(k) summary:

The InterActive/SwishPlus2 Implant System is a dental implant system. The application does not describe an AI/ML device.

Therefore, most of the requested information (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission. The 510(k) primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a dental implant device and not an AI/ML system, "acceptance criteria" here refers to demonstrating substantial equivalence to predicate devices across various technological characteristics and meeting relevant mechanical safety standards. There isn't a direct "performance metric" in the way one would define it for an AI/ML model (e.g., accuracy, sensitivity, AUC). Instead, performance is demonstrated by meeting or exceeding the mechanical properties of the predicate devices.

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

This is not an AI/ML device, so there is no "test set" in that context. The "testing" involved non-clinical performance and mechanical safety testing on the device prototypes/samples. The document does not specify the exact number of units tested for each mechanical test, but mentions "worst-case devices."

The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, located in Calabasas Hills, CA, USA. This is not retrospective or prospective patient data.

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

Not applicable, as this is not an AI/ML device requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO 14801 for mechanical properties of dental implants).

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are typically evaluated against pre-defined engineering thresholds and standards, not through expert adjudication.

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, as 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, as this is not an AI/ML device.

7. The Type of Ground Truth Used

For the non-clinical performance testing (mechanical strength, fatigue, torque tests), the "ground truth" is derived from established international and FDA-recognized engineering standards and guidance documents, specifically:

• FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments"
• ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants)
• ISO 17665 -1&2 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).

The device's performance is compared against the performance of similar predicate devices (physical products) that have already been cleared by the FDA.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device. There is no training set.

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

Not applicable, as this is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study to demonstrate the device meets acceptance criteria was a non-clinical performance testing program. This program involved:

• Mechanical Safety (Strength) Testing: Conducted on "worst-case devices" following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. This included:
  • Static compression bending tests
  • Fatigue tests
  • Implant driving torque tests
  • Abutment/screw torque to failure tests
    The results showed that the components exhibited equivalent mechanical strength to the predicate devices and that the implant/abutment combinations could withstand loads higher than functional masticatory loads.
• Sterilization Validation: Carried out in accordance with ISO 17665 -1&2, meeting the requirements and complying with the standards.
• Substantial Equivalence Comparison: Detailed comparison of the InterActive/SwishPlus2 Implant System's technological characteristics (indications for use, general design, placement method, material, surface treatment, body dimensions, interface, engaging features, and abutment compatibility) against multiple legally marketed predicate devices (e.g., NobelActive 3.0, NobelActive Internal Connection Implants, Spectra-System Dental Implants, SwissPlant Dental Implant System, Bicon Implants, Straumann ITI Dental Implant System). The submission argues that the new device has the same intended use, same technological characteristics, implant/abutment interface, and similar materials and surface treatments as the predicates.

No clinical testing was performed; the decision was supported by clinical evaluation based on the established safety and effectiveness of the predicate devices and the documented substantial equivalence.

Ask a specific question about this device

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.

Ask a specific question about this device