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Indications for Use for iPhysio® Profile Designer:

iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months.

Compatible Implant Systems:

Indications for Use for iPhysio® PEEK Temporary Abutment:

The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.

The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio® Profile Designers) be screwed into the implant using compatible anodized titanium screws during the 1st or the 2nd surgical intervention. The iPhysio® Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile Designers are available in multiples anatomical shapes and gingival heights, and are compatible with Nobel BioCare (NobelActive®, NobelReplace®, NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile Designers are straight (0°). Supporting screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with its corresponding height. The iPhysio® Profile Designer healing abutment screw is for placing the iPhysio® Profile Designer in the implant in the patient's mouth.

The iPhysio® Profile Designer remains in place throughout the bone and gingival healing process as well as during the taking of a digital or conventional impression, preserving the emergence profile during the impression. The abutment is only removed once to place and finally screw in the final abutment. Anatomical healing, implant impression, and placement of the temporary crown may all be done without removing the iPhysio® Profile Designer.

A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile Designer to which a non-load bearing temporary crown may be then placed for improved aesthetics during healing. To use the PEEK temporary abutment, the iPhysio® Profile Designer healing abutment screw is replaced with a compatible temporary abutment screw. The temporary crown is placed over the PEEK temporary abutment following modification of the abutment to the appropriate shape. The PEEK temporary abutment is connected onto the iPhysio® Profile Designer by a combination of friction and cement. All iPhysio® temporary abutments are manufactured from PEEK per ASTM F2026.

This document is part of a 510(k) summary for a medical device called "iPhysio® System." It details the comparison of the subject device to predicate devices to establish substantial equivalence, which is a key requirement for FDA clearance. The document focuses on non-clinical performance testing rather than studies involving human data or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document as it pertains to clinical performance and AI algorithm validation, which are not the primary focus of this 510(k) submission for this specific type of dental device.

However, I can extract the information related to acceptance criteria for the non-clinical performance testing and the reported results:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Note: The document explicitly states "Device met all predetermined acceptance criteria" or "Coating met all predetermined acceptance criteria" for several tests, which implies the acceptance criteria were established prior to testing and the device successfully met them. The specific numerical or qualitative thresholds for these criteria are not detailed in this summary for each test but are generally understood to align with relevant international standards (e.g., ISO 14801 for fatigue).

The following points cannot be answered from the provided text, as this is a 510(k) summary for a dental implant accessory, primarily relying on non-clinical (bench) testing and substantial equivalence arguments, rather than clinical trials or AI/image analysis studies.

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

• Not applicable / Not provided. The "tests" referred to are non-clinical bench tests (e.g., mechanical fatigue, material characterization), not clinical studies with human patient data. Sample sizes would refer to the number of physical device units tested for each non-clinical performance test. Data provenance in this context would be the lab where the bench tests were performed, which is not specified.

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 / Not provided. Ground truth, in the context of diagnostic AI or clinical studies, refers to disease labels or interpretations. For non-clinical bench testing, the "ground truth" is adherence to established engineering standards and material properties, validated by testing methodologies. No human experts are establishing "ground truth" in the clinical sense for these types of tests.

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

• Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations in clinical or imaging studies. This document describes bench testing, where outcomes are determined by physical measurements and adherence to engineering 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. This document explicitly states: "No clinical data was included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed as part of this submission. The device (dental healing abutment) does not involve AI.

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

• No. As noted above, this device is a physical dental implant component, not an AI algorithm.

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

• Not applicable / Not provided. For this submission, which relies on non-clinical testing, the "ground truth" is adherence to established engineering specifications, material standards (e.g., ISO 5832-3 for titanium alloy, ASTM F2026 for PEEK), and performance test methods (e.g., ISO 14801 for fatigue testing).

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. This device does not involve machine learning or a "training set."

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The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). 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).

This document is a 510(k) summary for the NB Mini Implant System by Arum Dentistry Co., Ltd. It declares that the device is substantially equivalent to existing predicate devices. Consequently, it does not contain a typical acceptance criteria table with reported device performance as would be found in a study demonstrating novel device performance. Instead, it provides a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here’s an analysis of the "acceptance criteria" and "study" information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document is a 510(k) summary for substantial equivalence, not a standalone performance study with explicit acceptance criteria. The "acceptance criteria" in this context are implicitly that the subject device's performance is substantially equivalent to legally marketed predicate devices. The "reported device performance" is presented through direct comparison of features and results of non-clinical benchtop tests against these predicate devices.

The table below summarizes the comparative information provided for the NB Fixture Mini (one component of the NB Mini Implant System) against its primary predicate and a reference device. Similar comparative summaries are provided for other components (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment Mini, Angled Abutment Mini, and Abutment Screw), all concluding substantial equivalence.

2. Sample size used for the test set and the data provenance

The document refers to a variety of non-clinical testing data for various components of the NB Mini Implant System:

• Mechanical performance testing (Fatigue test): "For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing." No specific numerical sample size is provided.
• Bone to Implant Contact (BIC) analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Surface area analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Pullout test: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Biocompatibility: Demonstrated by reference to ARUM DENTISTRY submission K213506.
• Sterilization validation: Performed according to ISO 11137-1 and ISO 11137-2 (method VDmax25 for 25 kGy dose, referenced from K213506), End User Moist Heat Sterilization Test (ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1, referenced from K213506), and LAL endotoxin testing (AAMI / ANSI ST72:2011/(R)2016).
• Shelf-Life: Accelerated aging method in accordance with ASTM F1980.

The data provenance is not explicitly stated as country of origin, retrospective or prospective, but all tests are non-clinical, meaning they were performed in a lab setting, likely by the manufacturer or a contract lab. The referenced 510(k) submissions (K213506, K190849, K220079, etc.) indicate these are devices marketed in the US, but the company (Arum Dentistry Co., Ltd.) is from the Republic of Korea.

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

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies requiring adjudication of human reader interpretations.

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 device is an endosseous dental implant system, not an AI or software-based diagnostic tool that would typically be evaluated with MRMC studies or AI assistance.

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

This section is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical performance tests:

• Mechanical fatigue: The "ground truth" or reference for evaluating performance is the established mechanical properties and fatigue resistance standards (e.g., ISO 14801), and the performance of the predicate devices.
• Biocompatibility: Demonstrated via material testing and reference to previous submissions, ensuring the material meets established safety standards for biological interaction.
• Sterilization: Ground truth is defined by sterility assurance levels (e.g., SAL of 10^-6) and adherence to recognized standards (ISO 11137, ANSI/AAMI ST79).
• Shelf-Life: Ground truth is established by test methods (ASTM F1980) that predict long-term stability and integrity.
• BIC, Surface Area, Pullout: These are physical measurements compared against predicate device performance, implying the predicate's performance serves as the reference for "substantially equivalent" ground truth.

8. The sample size for the training set

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set.

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

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set and corresponding ground truth.

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The NB Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). 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 Scan Healing Abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined marking for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification information is captured in the intraoral scan or model scan.

Here's a breakdown of the acceptance criteria and study information for the NB Implant System, based on the provided text. It's important to note that this document is a 510(k) summary for a dental implant system, which primarily relies on substantial equivalence to predicate devices and existing testing, rather than a de novo AI/software device that would have explicit AI performance acceptance criteria.

Therefore, the "acceptance criteria" here are related to demonstrating substantial equivalence for a medical device (dental implant), focusing on material safety, sterilization, and mechanical characteristics, rather than specific performance metrics for an AI algorithm. The study described is primarily non-clinical testing to support this equivalence.

Device Name: NB Implant System
Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
Product Code: DZE, NHA

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical dental implant system, the "acceptance criteria" are focused on demonstrating a device that is as safe and effective as a legally marketed predicate. Performance is demonstrated through non-clinical testing and comparison to predicates.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (biocompatibility, sterilization, shelf-life, MRI). It refers to the tests being performed "in accordance with" relevant ISO and ASTM standards, which would dictate minimum sample sizes for each specific test type.
• Data Provenance: All data referenced appears to be from non-clinical (laboratory/bench) testing. The document heavily relies on previously submitted data (K213506, K173374, K182448) from ARUM DENTISTRY Co., Ltd. and other manufacturers. The company's address is in Daejeon, Republic of Korea, suggesting the testing was likely conducted in Korea or by contract labs following international standards. The data is retrospective in the sense that it relies on previously generated and accepted data for predicate devices and earlier versions/components.

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

Not applicable. This is a submission for a physical medical device (dental implant), not an AI/software device that requires expert-established ground truth for a test set of images or clinical data. The ground truth for device safety and performance relies on physical measurements, material properties, and established laboratory testing protocols (e.g., ISO, ASTM standards).

4. Adjudication Method for the Test Set

Not applicable. No human adjudication of results is described, as the studies are non-clinical tests (e.g., sterilization reports, material testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic devices, not for physical dental implants.

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

Not applicable. This device is a physical dental implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Standardized Non-Clinical Testing: Adherence to established international standards (ISO, ASTM) for biocompatibility, sterilization, shelf-life, and material properties.
• Predicate Device Data: The safety and effectiveness of previously cleared, substantially equivalent predicate devices.
• Scientific Rationale/Literature: For MRI safety, peer-reviewed literature and scientific rationale are cited.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a "training set."

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

Not applicable. (See #8)

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The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.

The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. This abutment is to be used only with implants placed straight. It is made of Ti-6Al-4V ELI alloy. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use after the cementation of the Zirconia top-half.

The Scan Healing Abutment designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.

The provided text is a 510(k) summary for a medical device submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices based on comparisons of indications for use, design, materials, and non-clinical testing. It explicitly states that no clinical studies were submitted (Section 9). Therefore, the document does not contain information about acceptance criteria for device performance as would be demonstrated by a study with ground truth data.

However, it does describe the non-clinical tests performed to support substantial equivalence. Here's a breakdown of what the document provides regarding tests and an explanation for the absence of other requested information:

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

Since no clinical studies with performance metrics like sensitivity, specificity, accuracy, or effect sizes were performed, a table of acceptance criteria for diagnostic performance cannot be extracted from this document. The document describes non-clinical testing for safety and mechanical integrity.

However, the document does mention criteria for these non-clinical tests:

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

This information is not applicable as no clinical studies with human test sets were conducted or referenced. The non-clinical tests involved physical samples of the devices. For example, fatigue testing was performed on "worst-case TiGEN Abutment and compatible implant fixture constructs" but the specific number of samples is not provided. Data provenance for non-clinical lab tests is typically the manufacturing facility or a contracted lab, but specific details are not in this summary.

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 is not applicable as no clinical studies with ground truth established by experts were conducted.

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

This is not applicable as no clinical studies requiring expert adjudication were conducted.

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 is not applicable as this device is a dental abutment and not an AI-powered diagnostic device. No MRMC study was performed.

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

This is not applicable as this device is a dental abutment and not an algorithm.

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

For the non-clinical tests:

• Sterilization Validation: Ground truth is achieving the specified Sterility Assurance Level (SAL), verified through standard microbiological testing methods (e.g., bioburden and sterility testing).
• Pyrogen and Endotoxin Test: Ground truth is meeting the specified endotoxin limit, verified through standard endotoxin testing (e.g., LAL test).
• Biocompatibility: Ground truth is compliance with ISO 10993 series through tests like cytotoxicity, sensitization, irritation, etc., performed in a lab setting.
• Fatigue Testing: Ground truth is the device (abutment-implant construct) withstanding specified dynamic loading for a certain number of cycles without failure, as defined by ISO 14801.
• Accelerated Shelf Life Test: Ground truth is the maintenance of device properties over the projected shelf life, extrapolated from accelerated aging test data per ASTM F1980.
• MR Compatibility: Ground truth is the device behaving predictably and safely in an MRI environment, based on physics principles and empirical measurements of magnetic displacement and torque.

8. The sample size for the training set

This is not applicable as no machine learning or AI algorithm development was involved.

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

This is not applicable as no machine learning or AI algorithm development was involved.

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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The purpose of this submission is to expand the Dentium Prosthetics to include the Scan Abutments and Comfort Caps.

Scan Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final abutment.

Comfort Caps are used provisionally as an accessory to protect the dental abutment before final prosthesis.

They have the design feature that enable to transmit position and angulation data of implant when taking a digital impression using an intra-oral scanner.

The Scan Abutments and Comfort Caps are prefabricated and made of Ti-6AI-4V ELI (ASTM F136) or PEEK(ASTM F2026). Scan Abutments are compatible with Dentium Implant(K041368 Implantium and K160965 SuperLine or K153268 NR Line) and Comfort Caps are compatible with Dentium Prosthetics(K052957 Implantium and K172640 SuperLine or K153268 NR Line)

This document is a 510(k) Pre-Market Notification from the FDA regarding dental devices (Scan Abutments and Comfort Caps). It focuses on demonstrating substantial equivalence to previously cleared devices, rather than establishing performance against specific acceptance criteria for a novel AI/ML device.

Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/ML performance, ground truth, human readers, and training/test set specifics) are not applicable to this type of regulatory submission.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as a predicate and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate.
• Reported Device Performance (as demonstrated for Substantial Equivalence):
  • Indications for Use: The subject device has the same indication for use as the primary predicates: "Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation."
  • Technological Characteristics Comparison (Tables provided in Section 7): The document provides detailed comparison tables for Scan Abutments (vs. K172640, K153268, K173374, K172160) and Comfort Caps (vs. K171142, K172160). These tables demonstrate similarities in:
    • Device name, Manufacturer, 510(k) Number (where applicable)
    • Indication for use
    • Materials (Ti-6Al-4V ELI, PEEK – demonstrated to be identical to or commonly used in predicates)
    • Form (Preformed)
    • Sterilization (Non-sterile, similar to primary predicates; note on sterile reference predicates)
    • Use (Prescription)
    • Single Use Only (Yes)
    • Design characteristics: Diameter, Length, Connection type, Scanning feature (for Scan Abutments), Surface treatment.
  • Performance Data (Non-clinical):
    • Steam sterilization validation (ISO 17665-1 and ISO 17665-2), demonstrating a sterility assurance level (SAL) of 10-6. (This is a specific performance metric).
    • Biocompatibility of Ti-6Al-4V ELI (ASTM F136) was demonstrated by referencing a previous submission (K172640) using the same materials and manufacturing processes.
    • Cytotoxicity testing of PEEK (ASTM F2026) was performed according to ISO 10993-5.

N/A (Not Applicable) for this type of submission:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific "test set" in the context of an AI/ML model for performance evaluation is described. The performance data relates to material properties and sterilization, not diagnostic/AI performance on a dataset.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not a concept for these mechanical/material devices.
• 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 device is not an AI/ML diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with material standards, sterilization standards, and functional equivalence to predicates.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA document is for a medical device (dental abutments and caps) seeking 510(k) clearance based on substantial equivalence. It does not involve AI/ML components or comparative effectiveness studies of human readers, thus many of the questions are not relevant.

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