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ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm
• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular)
• · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP
• · Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm.

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

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

• Test Set Sample Size:
  • The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
• Data Provenance:
  • The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
  • The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

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

• This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
• The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

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

• This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

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 type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

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

• For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
• For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable as there is no training set for a physical medical device.

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The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

The LL Implant System consists of a one-piece implant and temporary cap. The LL Mini Onebody Implant is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: submerged type, tapered body, sided cutting edge. The LL Temporary Cap is made Polyoxymethylene (ASTM F1855) without any surface treatment.

The provided text does not contain detailed acceptance criteria and a study that proves the device meets them in the format requested. The document discusses the substantial equivalence of the "LL Implant System" to predicate devices, primarily focusing on materials, design, and general non-clinical testing performed according to ISO standards and FDA guidance.

Here's an analysis based on the information available and what is missing regarding your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

• Information Available: The document mentions that several non-clinical tests were performed (Fatigue Testing, Sterilization Validation, Shelf-Life Testing, Biocompatibility, Bacterial Endotoxin Testing, Surface Modification, and MR Safety). For some tests, it states that "the results have met the acceptance criteria" or "demonstrated equivalence to the predicate device."
• Missing Information: Specific numerical acceptance criteria for each test and the corresponding quantitative results/performance from the LL Implant System are not provided. For example, for "Fatigue Testing," it says it was done "according to ISO 14801:2016" and "expected to function properly," but it doesn't state the specific load cycles, force applied, and the device's measured endurance limits to compare against predefined acceptance thresholds. Similarly for "Bacterial Endotoxin Testing," it says "met the acceptance criteria," but the criteria itself and the measured endotoxin levels are absent.

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

• Missing Information: The document does not specify the sample sizes used for any of the non-clinical tests. It refers to "worst-case scenario" for several tests but doesn't quantify how many samples were included in these scenarios. Additionally, there's no mention of the data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical lab tests and not human subject studies.

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

• Not Applicable: This question is relevant for studies involving human data and expert review for ground truth establishment (e.g., diagnostic AI models). The studies described here are non-clinical, laboratory-based tests on a physical medical device (dental implant). Thus, there's no "ground truth" to be established by human experts in this context.

4. Adjudication Method for the Test Set

• Not Applicable: Similar to point 3, adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in ground truth labeling. This is not pertinent to the non-clinical device testing described.

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

• Not Performed: The document does not mention any MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance. The device is a physical dental implant, not an AI software.

6. Standalone (Algorithm Only) Performance Study

• Not Performed: This question is referring to AI algorithm performance. The device is a physical dental implant, not an AI algorithm.

7. Type of Ground Truth Used

• Not Applicable (for clinical ground truth): As these are non-clinical, laboratory tests, the "ground truth" aligns with established scientific and engineering principles, international standards (e.g., ISO 14801 for fatigue, ISO 11137 for sterilization), and FDA guidance documents. The "truth" is whether the device physically performs according to these standards, not an expert consensus or pathology on a biological sample.

8. Sample Size for the Training Set

• Not Applicable: This question typically relates to AI/ML models. The LL Implant System is a physical device, and therefore, there is no "training set" in the context of an algorithm.

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

• Not Applicable: As there is no training set for an AI model, this question is not relevant.

Summary of what is available (and implied in relation to "acceptance criteria" and "proof"):

• Acceptance Criteria (Implied): The acceptance criteria are largely implied by compliance with specific ISO standards (e.g., ISO 14801:2016 for fatigue, ISO 11137-1 for sterilization, ISO 10993-1 for biocompatibility) and FDA guidance documents. The document states that the test results "met the acceptance criteria" or "demonstrated substantial equivalence" to predicate devices, indicating that the predefined thresholds within these standards were achieved.
• Study That Proves the Device Meets Criteria: Various non-clinical studies were conducted:
  • Fatigue Testing: Performed on the subject device according to ISO 14801:2016 and FDA guidance.
  • Sterilization Validation: Gamma sterilization (implants) validated per ISO 11137 series; End-user sterilization (caps) validated per ISO 17665 series and FDA guidance. These were leveraged from previous submissions (K223924, K231079).
  • Shelf-Life Test: Performed per ASTM F1980 (leveraged from K223924).
  • Biocompatibility Testing: Performed per ISO 10993-1 and FDA guidance, including Cytotoxicity per ISO 10993-5 (leveraged from K223924, K231079).
  • Bacterial Endotoxin Testing: Performed per USP and and FDA guidance.
  • Surface Modification Information: Evaluation per FDA guidance, including surface roughness, composition analysis, SEM, and ICP analysis.
  • MR Safety: Worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.

In short, the document confirms that required non-clinical tests were conducted according to recognized standards and guidance, and the results were deemed to meet acceptance criteria, thereby demonstrating substantial equivalence to predicate devices. However, it does not provide the specific quantitative details of these acceptance criteria or the measured performance results for each test.

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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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STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.

STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function.
STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.

The provided document is a 510(k) summary for the STERI-OSS Implant System, which is a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets pre-defined acceptance criteria for performance in a clinical setting. For medical devices undergoing 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific novel performance acceptance criteria through clinical studies.

Therefore, the requested information elements such as "acceptance criteria and the reported device performance," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are typically not applicable in the context of a 510(k) substantial equivalence submission for a device like a dental implant. These elements are more commonly associated with clinical trials or performance studies for novel devices or software with AI/ML components requiring new clinical evidence.

The document describes non-clinical testing to demonstrate that the differences between the subject device and predicate devices do not affect substantial equivalence.

Here's a breakdown of the available and non-applicable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the format typically used for performance studies with defined acceptance criteria for clinical outcomes. The document instead presents a comparison of technological characteristics with predicate devices and reports on non-clinical engineering and materials testing to support substantial equivalence.

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The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use.

The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.

The provided text is an FDA 510(k) clearance letter for a dental implant abutment system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, AI-driven or novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria for a device's performance, a study proving it meets those criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The "Non-Clinical Test Data" section lists various engineering and material tests (surface modification, sterilization, biocompatibility, fatigue, MRI safety) that were performed to demonstrate the device's safety and effectiveness in comparison to the predicate devices, but these are not performance metrics that would be evaluated against specific acceptance criteria for a new and complex medical device with an AI component or a diagnostic function.

In summary, none of the requested information to describe acceptance criteria and the study proving the device meets those criteria is present in this FDA 510(k) document because it's for a dental implant abutment, not a device with the type of performance metrics implied by your query.

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The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (06.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

This document describes a 510(k) premarket notification for the S-Plant Dental Implant System, which is a Class II medical device. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. However, it does not contain information typically found in a study demonstrating the device meets acceptance criteria related to clinical performance or AI models.

The provided text solely focuses on establishing substantial equivalence based on comparisons to predicate and reference devices regarding design, materials, indications for use, and non-clinical testing (biocompatibility, sterilization, surface modification, and MRI compatibility). There is no mention of an AI component, human-in-the-loop performance, or specific performance metrics like sensitivity, specificity, or AUC against a clinical ground truth for the S-Plant Dental Implant System itself.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance (for clinical performance/AI).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

The provided text is a 510(k) summary for a dental implant system, which is a physical device, and not an AI/software device. The "acceptance criteria" discussed are related to regulatory conformance and manufacturing standards, not clinical performance metrics in the context of an AI study.

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The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw tvpe. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Dual Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

The provided text describes the regulatory clearance of the S-Plant Dental Implant System and its components (Fixture, Dual Abutment, Healing Abutment, Abutment Screw, Cover Screw) by demonstrating substantial equivalence to predicate and reference devices. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing and comparison with existing, legally marketed devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA's "substantial equivalence" framework, meaning the device must perform as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness. The reported device performance is demonstrated by comparing its design, materials, intended use, and technological characteristics to the predicate and reference devices, and by non-clinical testing that meets established industry standards.

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

The information provided does not describe a clinical study with a test set of patient data. Instead, it details non-clinical testing (bench testing, biocompatibility testing, sterilization validation, shelf-life determination, and MRI safety assessment) and a comparative analysis of the device's characteristics against predicate and reference devices.

• Sample Size for Test Set: Not applicable in the context of patient data. The "test set" refers to samples of the device components used for various laboratory tests (e.g., material samples for biocompatibility, sterility test units, accelerated aging samples, MRI phantom testing). The specific number of samples for each non-clinical test is not detailed in this summary but would be found in the full submission.
• Data Provenance: The studies are non-clinical (laboratory/bench testing) and therefore do not involve patient data from specific countries or have a retrospective/prospective nature in the typical clinical sense. The tests were conducted by the manufacturer (IDIS Co., Ltd. in Republic of Korea) or their designated testing facilities to demonstrate compliance with international standards (ISO, ASTM, ANSI/AAMI) as required for FDA clearance.

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

Not applicable. This is not a study involving expert readers interpreting medical images or clinical outcomes. Ground truth for non-clinical tests is established by adhering to defined scientific methodologies and international standards for material science, biomechanics, and biocompatibility.

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

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for ground truth establishment.

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 submission does not involve an AI-enabled device or MRMC studies.

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

Not applicable. This submission does not pertain to an algorithm or AI device.

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

The "ground truth" for the substantial equivalence determination and non-clinical testing is based on:

• Established Industry Standards and Regulations: ISO 7405, ISO 10993 standards (biocompatibility), ISO 11137-1/2, ANSI/AAMI ST79 (sterilization), ASTM F1980 (shelf life), ASTM F67, ASTM F136 (materials), and FDA guidance documents (e.g., "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
• Predicate and Reference Device Specifications: The detailed characteristics (materials, dimensions, surface treatment, intended use) of the legally marketed predicate and reference devices serve as the benchmark for comparison to claim substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable, as no training set is described.

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The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The medical device described in the document is the SS Abutment System from Osstem Implant Co., Ltd. This device is an endosseous dental implant abutment, classified as Class II under regulation 21 CFR 872.3630 with product code NHA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to predicate devices, focusing on design, function, indications for use, material, manufacturing process, and performance characteristics. The acceptance criteria are implicitly aligned with the performance characteristics of the predicate devices, particularly regarding mechanical properties, biocompatibility, sterilization, and MR compatibility.

For ComOcta Milling Abutment: Lengths (L 14, L 14.35) not in predicate range, but diameter range is same. Performance: "fatigue of the proposed device is considered to be equal to or greater than that of the predicate device." No additional fatigue testing. Modifiability is within safe limits (min post height 4mm, gingival height 1-3mm, no angulation).

For Port Abutment: Larger diameter (Ø6.06) compared to predicate (Ø4.8), same length range. Performance: "added diameter is bigger than reference device and the lengths 3.5~6.5mm is same as the range of reference device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For O-ring Abutment: Larger diameter (Ø4.3) compared to predicate (Ø3.5), same gingiva height range. Performance: "added diameter is bigger than reference device and the gingiva height 0~4mm is same as the range of predicate device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For Closing Screw: Longer dimensions than predicate. Performance: "does not affect safety and effectiveness because it is used to protect the exposed platform of the implant during healing period." No additional fatigue testing. |
| Biocompatibility | Compliance with FDA Guidance Document Use of International Standard ISO 10993-1. The material composition of the device should be safe for biological contact. | "The SS Abutment System has same materials, manufacturer, manufacturing process etc., as predicate devices. Therefore, we didn't conduct additional biocompatibility test." |
| Sterilization Validation | Demonstrated sterility and maintenance of sterility throughout the claimed shelf-life. The sterilization process should be validated and consistent with predicate devices or established methods. | "Validation of the gamma irradiation process was previously conducted for the predicated device. There has been no change to the manufacturing or sterilization processes since then and the subject devices do not present a new worst case for sterilization validation; therefore, additional validation is not required." |
| Shelf-life | Stability and integrity of the device over its claimed shelf-life. | "SS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life." The predicate device likely had an 8-year shelf life for some components (e.g., Closing Screw), and this is maintained where applicable. |
| MR Compatibility | Safety in the Magnetic Resonance (MR) Environment, including assessment of magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | "Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance." |

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

The document does not describe a traditional "test set" in the context of a clinical performance study. Instead, performance is established through non-clinical testing and comparison to predicate devices, often leveraging the fact that the subject device either has:

• Identical characteristics to a predicate.
• Dimensions that are considered to offer equivalent or superior performance (e.g., larger diameter on an implant component).
• A different intended use/loading condition (e.g., overdenture dispersing load) that mitigates concerns about increased stress from dimensional changes.

Therefore, there is no sample size for a "test set" from patients or images. The "samples" would be the configurations of the devices tested in laboratory settings (e.g., for fatigue), or the material samples for biocompatibility, or the specific device designs analyzed for MR compatibility. The document does not specify the number of units tested for any of these non-clinical evaluations, but refers to "worst-case scenarios" for mechanical testing, which implies selection of specific configurations deemed most challenging.

Data Provenance: Not applicable as no human or image data is used for performance testing. The "data" comes from laboratory physical testing, material standards, and scientific literature.

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

Not applicable. As this is a non-clinical submission based on substantial equivalence to predicate devices and established standards (e.g., ISO, ASTM, FDA guidance), there is no "ground truth" derived from expert consensus on patient data. The "truth" is based on adherence to engineering and material science principles, and regulatory guidelines.

4. Adjudication method for the test set

Not applicable for the reasons outlined in 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

Not applicable. This device is a physical dental implant abutment, not an AI-powered diagnostic or assistive tool.

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

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

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Standards and Guidance Documents: ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility, and FDA guidance documents for dental implants and MR compatibility.
• Material Science: Established properties of Titanium Alloy (ASTM F136), Titanium Gr 3 & 4 (ASTM F67), and POM (Polyoxymethylene).
• Existing Validations: Relying on previous biocompatibility, sterilization, and shelf-life validations performed for predicate devices with identical materials, manufacturing processes, or for which the subject device does not represent a new worst-case.
• Scientific Rationale: For MR compatibility, scientific literature and rationale are used.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the reasons outlined in point 8.

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The LW 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).

The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.

The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."

Here's an interpretation of the implied acceptance criteria and the summary of reported performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical test performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.

Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.

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

This information is not applicable to the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.

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

No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:

• Sterility: Defined by ISO 11137 with an SAL of 10-6.
• Biocompatibility: Defined by ISO 10993 standards.
• Fatigue: Defined by ISO 14801.
• Bacterial Endotoxin: Defined by USP and .
• Surface Characteristics: Defined by FDA special controls guidance for dental implants.

The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.

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

This information is not applicable, as there is no "training set" for this physical medical device.

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The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.

This document describes a 510(k) premarket notification for a medical device called the "ET Abutment System," which is an endosseous dental implant abutment. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical trials.

Therefore, the submission does not contain information about specific "acceptance criteria" for an AI algorithm's performance, nor does it detail a study proving such a device meets these criteria in the typical sense of AI/ML performance evaluation. The "studies" referenced are non-clinical bench tests demonstrating the physical and material properties of the dental abutments are comparable to existing, legally marketed devices.

Based on the provided text, here's an analysis of the "acceptance criteria" and "proof" in the context of this 510(k) submission:

The acceptance criteria and proof fundamentally revolve around demonstrating substantial equivalence to predicate devices, not performance against a specific clinical metric for an AI algorithm.

Missing Information:

The document concerns a physical dental device (abutment system), not an AI/ML powered device. As such, the concept of "acceptance criteria" for AI performance, clinical study design for AI (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this submission. The FDA letter confirms the device type: "Endosseous Dental Implant Abutment."

However, to address the prompt's implied need for "acceptance criteria" and "studies" as they relate to this specific device (dental abutment), I will interpret the request within the context of a 510(k) submission for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a Dental Abutment System)

In a 510(k) submission for a dental abutment, "acceptance criteria" are typically defined by demonstrating that the proposed device has the same technological characteristics and similar performance to legally marketed predicate devices, or that differences do not raise new questions of safety and effectiveness. The "reported device performance" comes from non-clinical bench testing.

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

Since this is a physical medical device submission and not an AI/ML algorithm:

• Sample Size for Test Set: Not applicable in the context of an AI test set. For physical device testing, the sample sizes would be determined by the relevant ISO standards (e.g., ISO 14801 for fatigue testing). These specific numbers are not detailed in the summary but are typically part of detailed test reports that support the conclusion of substantial equivalence.
• Data Provenance: The data comes from non-clinical testing (bench tests) performed to standard specifications (e.g., ISO 14801). The "ET Abutment System are contract manufactured by the predicate device manufacturer," implying the manufacturing process and potentially some historical performance data are shared or directly comparable.
  • Country of Origin: Not specified for the non-clinical test data itself, but the applicant (Hiossen Inc.) is in Fairless Hills, Pennsylvania, USA. The predicate manufacturer (Osstem Implant Co., Ltd.) is generally based in South Korea, suggesting potential international collaboration or shared manufacturing data.
  • Retrospective or Prospective: Not applicable in the context of patient data. The non-clinical tests would be conducted prospectively on newly manufactured devices.

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

• This concept is not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert labeling or interpretation for "ground truth." The "ground truth" here is the adherence to material specifications, dimensional tolerances, and performance under specific mechanical and biological test conditions as defined by international standards.

4. Adjudication Method for the Test Set

• This concept is not applicable as there is no "test set" in the sense of clinical cases requiring interpretation or adjudication by multiple readers/experts. Performance is based on mechanical, material, and sterilization testing against predefined standards.

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

• Not applicable. This type of study is for evaluating human performance with or without AI assistance, typically in image interpretation or diagnosis. This submission is for a physical dental implant component. The document explicitly states: "No clinical performance report(s) is being submitted."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This pertains to AI algorithm performance.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards, material specifications, and performance data from validated non-clinical bench tests. This includes:
  • ASTM (American Society for Testing and Materials) standards for materials (e.g., ASTM F136 for titanium alloy).
  • ISO (International Organization for Standardization) standards for testing medical devices (e.g., ISO 14801 for fatigue testing of dental implants, ISO 17665-1 for moist heat sterilization).
  • FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
  • Direct comparison to the established characteristics and performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

• Not applicable. This concept relates to AI/ML model development. There is no "training set" for a physical dental abutment. The device's design and manufacturing rely on established engineering principles and prior knowledge from the predicate device.

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

• Not applicable. Again, this refers to AI/ML model training. The "ground truth" for developing a physical device is derived from engineering design principles, material science, and the performance history of similar devices.

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