Search Results

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.

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 MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.

The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.

Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.

Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.

Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.

Example for Healing Abutment:

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

• Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
• Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).

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

Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes is described.

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 dental implant abutment, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Comparison to legally marketed predicate devices (their established safety and effectiveness).
• Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
• Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This pertains to AI algorithms.

Ask a specific question about this device

The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
  It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
  It is specifically recommended for:
• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):

• Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
• Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
  Diameter X Total Length (Thread Length):
• Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
• Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
  Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0
  Gingival (Cuff) Height: Not Found

The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

The provided text is an FDA 510(k) summary for a dental implant device (BLUEDIAMOND IMPLANT). It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, it does NOT contain the specific information required to answer your prompt, such as:

• Acceptance Criteria for AI/ML Performance: The document does not describe performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI/ML models. Instead, it focuses on physical and material properties, and mechanical performance (fatigue, pull-out).
• Study Proving Device Meets Acceptance Criteria for AI/ML: No AI model training, validation, or testing is described. The "performance test" section refers to fatigue tests and pull-out tests, which are engineering tests for the physical implant, not for an AI algorithm.
• Sample Sizes for Test Set (AI/ML): Not applicable, as there's no AI/ML test set.
• Data Provenance (AI/ML): Not applicable.
• Number of Experts/Qualifications (AI/ML Ground Truth): Not applicable.
• Adjudication Method (AI/ML Ground Truth): Not applicable.
• MRMC Study (AI/ML): Not applicable.
• Standalone Performance (AI/ML): Not applicable.
• Type of Ground Truth (AI/ML): Not applicable.
• Sample Size for Training Set (AI/ML): Not applicable.
• How Ground Truth for Training Set was Established (AI/ML): Not applicable.

The document primarily discusses:

• Device Description: Material (CP Ti Grade 4), surface treatment (S.L.A), dimensions, components.
• Indications for Use: Placement in maxillary/mandibular molar areas for prosthetic support, delayed and immediate loading protocols, specific recommendations for 5mm thread length implants.
• Substantial Equivalence: Comparison of the BLUEDIAMOND IMPLANT to a primary predicate device (ARi ExCon Implant System) and several reference devices based on design, dimensions, material, surface treatment, sterilization, shelf life, and features.
• Non-Clinical Testing: Biocompatibility, pyrogen/endotoxin testing, sterilization validation, shelf life, modified surface treatment evaluation, and performance test (fatigue test in accordance with ISO 14801, and pull-out testing), and MR compatibility.

In summary, the provided text describes a physical dental implant device and its regulatory submission to the FDA, not an AI/ML-driven medical device. Therefore, it does not contain the information requested about AI acceptance criteria, performance studies, or ground truth establishment.

Ask a specific question about this device

The TiGEN Abutment, PMMA 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.

The PMMA Abutment is indicated to be used pror to the final components to maintain, stabilize and shape the soft tissue during the healing plase. They must be placed out of occlusion and are for temporary use (3 months).

For TiGEN Abutment and PMMA Abutment, all digitally designed abutments for use with PMMA Abutment and TiGEN 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 PMMA Abutment is a temporary prosthesis used until the final prosthesis is placed for up to three months. The PMMA Post is machined with the temporary prosthetic in accordance with the intraoral structure by using dental CAD/CAM technology. The PMMA Cuff is made of Ti-6Al-4V ELI alloy and available in various gingival heights. The PMMA Post is made of Polymethyl methacrylate and available in various diameters and lengths so that it can be used according to individual patient conditions. All PMMA Abutment is provided non-sterile with abutment screw. The milled PMMA Abutment must be sterilized by users prior to use.

The Scan Healing Abutment designed to aid in soft tissue contouring during 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.

This document pertains to a 510(k) premarket notification for dental implant abutments and does not contain information about an AI/ML medical device. Therefore, a table of acceptance criteria and a study proving the device meets the criteria, as requested by the prompt, cannot be extracted from the provided text for an AI/ML context.

The document discusses the substantial equivalence of the "TiGEN Abutment, PMMA Abutment and Scan Healing Abutment" to already marketed predicate devices. The studies mentioned are primarily bench tests, biocompatibility evaluations, and sterilization/shelf-life validations, which are standard for physical medical devices. There is no mention of an AI/ML component, AI/ML device performance metrics, or related study methodologies like multi-reader multi-case (MRMC) studies.

Without information on an AI/ML component, the requested details such as sample size for test sets (for AI), data provenance, expert ground truth establishment, MRMC studies, standalone AI performance, and training set details are not applicable and cannot be provided.

Ask a specific question about this device

N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

The N2 dental operative unit is primarily evaluated against safety and performance standards for dental equipment and medical electrical equipment. As such, the acceptance criteria and study designs differ significantly from those for AI-powered diagnostic or prognostic devices.

Here's an analysis of the provided information, structured to address your specific points where applicable, and noting where the information is not relevant to this type of device:

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

For the N2 dental operative unit, the "acceptance criteria" are compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, cleaning/sterilization validation, and software validation. The reported device performance is that it complied with these standards.

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

For this type of device, "test set" and "data provenance" don't apply in the way they do for AI/diagnostic devices. The evaluation of N2 relies on bench testing and compliance with recognized standards.

• Bench Testing: This involves testing the physical device and its components in a controlled laboratory environment against specified parameters (e.g., electrical measurements, pressure limits, temperature control, mechanical movements). The "sample size" would typically be a representative number of units from a production batch or prototypes. The document doesn't specify the exact number of units tested for each standard, but it's understood to be sufficient for demonstrating compliance.
• Data Provenance: This is not relevant. The testing is performed in accordance with international standards, and the results are primarily engineering and performance measurements, not patient data.

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

This is not applicable to the N2 device. "Ground truth" in the context of diagnostic performance (e.g., presence/absence of a disease) is established by expert consensus, pathology, or outcomes data. For a dental operative unit, the "ground truth" is adherence to engineering specifications and safety standards, which is verified through objective measurements and test procedures, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret medical images or data and their decisions need to be reconciled to establish a consensus ground truth. For equipment like N2, compliance is determined by passing objective tests against defined standards, not by human interpretation.

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. The N2 is a dental operative unit (a piece of hardware for dental procedures), not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation. Therefore, an MRMC study is completely irrelevant.

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

This is not applicable. The N2 device is not an algorithm. Its "standalone performance" is its ability to function safely and effectively as a dental operative unit, which is demonstrated through component testing, system integration testing, and compliance with the listed standards. The software components are for controlling the unit's functions, not for standalone diagnostic or analytical tasks.

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

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for this device's safety and effectiveness is its conformance to established engineering and medical device standards through objective measurements and validated processes.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. The N2 device is a hardware unit with embedded software for control; it does not utilize machine learning in its described function.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

The submission includes descriptions for the following devices: Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, and Crown Screw. Each description details the intended use, material, surface treatment, sterilization, single use status, dimensions, and compatible implant systems.

The provided document, a 510(k) premarket notification from MegaGen Implant Co., Ltd. for their "MegaGen Dental Implant Abutment" device, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving that the device meets specific acceptance criteria through a standalone study.

For medical devices, especially those going through the 510(k) pathway, acceptance criteria are typically based on showing that the new device performs as safely and effectively as a legally marketed predicate device. The "study" proving this is primarily a non-clinical performance testing (bench testing) and a comparison to predicate devices. Clinical studies are often not required for 510(k) submissions, as explicitly stated in this document ("No clinical studies are submitted.").

Therefore, the acceptance criteria are implicitly defined by the performance characteristics of the predicate devices and general standards (like ISO 14801 for dental implants) as outlined in the "Summary of Non-Clinical Testing" section. The device performance is demonstrated through a comparative analysis to these predicates and the results of the bench testing.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" for the subject device are fundamentally its demonstration of substantial equivalence to predicate devices, meaning it performs as safely and effectively. The "reported device performance" is a direct comparison to the predicate devices and adherence to relevant standards.

The document provides extensive comparison tables for each component of the MegaGen Dental Implant Abutment system against its predicate and reference devices. Below is a representative excerpt from these tables, focusing on a few key components to illustrate the comparison:

Example: Scan Healing Abutment

Summary of Device Performance (Based on "Substantial Equivalence Discussion" sections for all components):

The subject device is deemed substantially equivalent to its predicate/reference devices across all listed components (Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, Crown Screw).

Any identified differences in characteristics (e.g., specific dimensions like diameter, gingival height, post height, total length, or surface treatment for some components) are explicitly discussed and concluded not to affect substantial equivalence. This is often supported by arguing that the differences are minor, fall within the range of cleared devices, allow for more precise treatment, or are supported by bench testing (e.g., fatigue tests for worst-case scenarios).

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

The document does not detail specific sample sizes for test sets in the context of clinical data, as no clinical studies were submitted.

For non-clinical testing (bench tests), the document states:

• "The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria."
• For ZrGEN Abutment, AXA Abutment (Angled type), and other potentially "worst-case" scenarios, fatigue tests were conducted to demonstrate performance and stability.

The data provenance is pre-market non-clinical testing data generated by the manufacturer. The country of origin for the manufacturing and testing is Republic of Korea (MegaGen Implant Co., Ltd. is based in Daegu, Republic of Korea). The data is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate equivalence.

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

This information is not applicable (N/A) as no clinical studies were conducted or submitted. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (like ISO 14801) and established testing methodologies, not typically by expert consensus of medical professionals on a test set.

4. Adjudication Method for the Test Set

This information is N/A as no clinical studies with human readers or image interpretation were conducted.

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

This information is N/A as no clinical studies were conducted, and certainly no MRMC studies involving human readers, as this is a physical dental implant component, not an AI or imaging device that would typically involve human-in-the-loop performance evaluation.

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

This information is N/A as the device is a physical dental implant abutment, not a software algorithm.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is:

• Performance specifications derived from legally marketed predicate devices.
• Adherence to recognized international standards (e.g., ISO 14801 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 11137 for sterilization) for manufacturing and material properties.
• Results of non-clinical bench testing to confirm physical and mechanical performance characteristics.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical study since none were performed.

8. The Sample Size for the Training Set

This information is N/A. The device is a physical product, not an AI/ML model that requires a "training set."

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

This information is N/A as there is no training set for a physical device.

Ask a specific question about this device

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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 ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

The provided text is an FDA 510(k) premarket notification summary for the "ARi ExCon Implant System." It details various components of the dental implant system (implants, cover screws, healing abutments, etc.) and compares them to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study, such as an MRMC study. The "Performance test" section on page 25-26 only mentions fatigue testing according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of subject devices (implant components), and that test results met pre-set criteria. This is a mechanical performance test, not a clinical or human-reader study.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (in the context of AI/human performance).
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (clinical/AI performance).
8. Training set sample size.
9. How training set ground truth was established.

The document primarily focuses on demonstrating substantial equivalence of the dental implant components through material comparisons and mechanical bench testing to predicate and reference devices, not on the performance of a medical AI device or human-in-the-loop performance with AI assistance.

Ask a specific question about this device

R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.

R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).

The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.

R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.

R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.

The provided text is a 510(k) summary for the R2GATE Lite™ device and does not contain the specific details about acceptance criteria, device performance, and the study methodologies typically found in a comprehensive clinical or performance evaluation report. The document primarily focuses on establishing substantial equivalence to a predicate device (R2GATE Windows).

However, I can extract and infer some information related to software testing and general claims.

Here's an analysis based on the provided text, with a clear indication of what is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the R2GATE Lite™ device. It mentions "Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices." and "Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input."

This implies that the device met its functional and performance requirements as defined internally by the manufacturer, but these specific requirements and their numerical outcomes are not detailed in this summary.

General Software Functionalities (Implied Performance):

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

The 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for either training or testing data. The testing mentioned is "Software verification and validation," which includes unit tests, integration tests, system tests, and acceptance tests. These typically involve synthetic data, simulated scenarios, and potentially real patient data for validation, but the details are not provided.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a "pre-planning software" for dental implant placement and surgical treatment, and its primary function described is viewing, measuring, and approving plans generated by the predicate device (R2GATE Windows), suggesting a focus on functional equivalency rather than comparative clinical performance with human readers.

6. Standalone Performance Study

While the "Software verification and validation" (V&V) activities listed (Unit test, Peer Code Review, Integration test, Internal release test, Formal system test, Acceptance test) can be considered forms of standalone testing for the algorithm's functionality, the document does not detail a specific standalone performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for any AI or algorithmic component, as the device is presented as an "image viewer" and "pre-planning software" that primarily interfaces with another cleared device (R2GATE Windows).

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function as a pre-planning and viewing tool for dental implants, ground truth would likely relate to the accuracy of measurements, correct rendering of 2D/3D images, proper display of generated nerve canal and implant models, and accurate application of revision/approval functions. This type of ground truth is often established through technical specifications and verification against expected outputs.

8. Sample Size for the Training Set

The document does not provide any information about a training set sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how ground truth for a training set was established.

In summary, the provided FDA 510(k) summary for R2GATE Lite™ focuses on demonstrating substantial equivalence through a comparison of intended use, indications for use, and functional descriptions with a predicate device. It indicates that software verification and validation activities were performed to confirm performance requirements were met, but it does not provide detailed quantitative performance metrics, study designs, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical or performance study report. This level of detail is often not required or included in the public 510(k) summary for certain device types, especially those classified as image management and processing systems.

Ask a specific question about this device

-Healing Abutment, Cover Screw (previously cleared per K210826) MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
-Multi-unit Abutment, Multi-unit Angled Abutment (previously cleared per K203808) The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
-AnyOne External Implant System (previously cleared per K203554) The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyOne Onestage Implant System (previously cleared per K210161) The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading. -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
-Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (previously cleared per K192614) Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.
-ST Internal Implant System (previously cleared per K192347) The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyRidge Octa 1 Implant System (previously cleared per K182448) The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing situations and with the clinical protocols: - Delayed loading. - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

• Advanced Intermezzo Implant System (previously cleared per K191127) Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic onestage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
  -MiNi Internal Implant System (previously cleared per K150537) The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM (previously cleared per K140091) The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 06.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -ANYONE™ INTERNAL IMPLANT SYSTEM (previously cleared per K123988) The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM (previously cleared per K123870) The Xpeed®AnyRidge®Intemal Implant System is intended to be surgically placed in the maxillaryor mandbular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or filly edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily an FDA 510(k) clearance letter for the "MegaGen Dental Implant Systems Portfolio - MR Conditional." It lists various implant systems and their indications for use, many of which were previously cleared.

The letter focuses on regulatory approval, substantial equivalence, and compliance with general controls and other FDA regulations for medical devices. It does not include details on specific performance metrics, clinical studies, sample sizes, ground truth establishment, or expert evaluations that would be necessary to answer your request.

Ask a specific question about this device

· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

· Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading

Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

This appears to be a 510(k) summary for a dental implant, "Bone Chamber Implant," seeking substantial equivalence to existing predicate devices. Consequently, the document describes non-clinical bench testing to demonstrate equivalence, rather than clinical trials with human subjects. Therefore, many of the requested items related to clinical study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) will not be applicable and the acceptance criteria will be based on engineering performance standards.

Here's an analysis based on the provided text:

Key Takeaway: The device's acceptance criteria and proven performance are primarily based on demonstrating mechanical equivalence to predicate devices through bench testing, specifically fatigue testing, following ISO and FDA guidance. No clinical studies were performed.

Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are the ability of the device to meet the specified performance standards in the referenced guidance documents and ISO standards, and to perform comparably to the predicate devices. The "reported device performance" is that the device met these criteria.

Study Details (Non-Clinical Bench Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical count for each test (e.g., number of implants tested for fatigue). The document states "the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'." For regulatory submissions like 510(k), compliance with the standards' requirements for sample size is assumed.
   • Data Provenance: The studies were non-clinical bench tests, not involving human data. The company is MegaGen Implant Co., Ltd., located in Daegu, South Korea. The testing was conducted internally or by a contracted lab to meet international and FDA standards.

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

   • Not Applicable. This was non-clinical bench testing of physical properties, not an assessment requiring expert clinical judgment or ground truth determination (like image interpretation). The "ground truth" here is the physical measurement against a standard.

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

   • Not Applicable. This refers to clinical adjudication, which is not relevant for bench testing.

4. 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. No MRMC study was done, as this is a physical dental implant, not an AI software or imaging device that human readers would interpret.

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

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

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

   • Engineering Standards and Specifications. The "ground truth" for non-clinical testing refers to the established requirements and thresholds defined by international standards (e.g., ISO 14801) and FDA guidance documents for medical device performance (e.g., fatigue strength, biocompatibility, sterilization efficacy). The device's performance is compared against these quantitative and qualitative criteria.

7. The sample size for the training set:

   • Not Applicable. This refers to the training of an algorithm or AI model. This device is a physical product.

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

   • Not Applicable. As above, this refers to algorithm training.

Ask a specific question about this device

N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronicallycontrolled chair movements with software and water unit functions.

This document describes the N2, a dental operative unit, and its substantial equivalence to a predicate device (K183347), K3. The submission focuses on non-clinical testing for safety and performance rather than AI-driven image analysis. Therefore, many of the requested fields regarding AI performance, such as sample size for test/training sets, data provenance, number and qualification of experts, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.

The document details the device's technical characteristics, intended use, and indicates that no clinical studies were deemed necessary. The acceptance criteria and "reported device performance" are primarily demonstrated through compliance with various international standards and specific bench tests, rather than metrics like sensitivity, specificity, or accuracy which would be typical for an AI-enabled diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the submission describes a physical dental operative unit, not an AI/software device that processes medical image data or other patient-specific data for diagnostic or prognostic purposes. The "testing" refers to bench testing and compliance with electrical, mechanical, and safety standards for the device itself.

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. Ground truth, in the context of expert consensus, is typically established for diagnostic tasks where human interpretation is the gold standard. For this device, "ground truth" would relate to the physical and functional parameters meeting engineered specifications and safety standards, validated through direct measurement and compliance testing (e.g., measuring current, pressure, chair movement ranges).

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

This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the testing described here.

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. MRMC studies are conducted for systems that assist human readers in tasks like image interpretation. The N2 is a dental operative unit, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The N2 is a physical device with some electronic controls (firmware), not a standalone algorithm.

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

The "ground truth" for this device's performance is primarily established by:

• Engineering Specifications: The pre-set criteria for bench tests, electrical safety, and mechanical performance are based on design specifications and industry standards.
• Regulatory Standards: Compliance with international standards such as IEC 60601-1, IEC 80601-2-60, ISO 10993, ISO 17665, and ISO 16954 forms the basis of "truth" for safety and essential performance.
• Manufacturer Recommendations: For cleaning/sterilization, the validation is against the manufacturer's recommended protocols.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software validation refers to standard software development, verification, and validation (V&V) processes for firmware, not AI model training.

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

This is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) submission for a dental operative unit, which is a physical device. The "study" mentioned refers to non-clinical bench testing and compliance with various international electrical, mechanical, safety, and biocompatibility standards to demonstrate substantial equivalence to a predicate device. It is not an AI-enabled diagnostic or assistive device, so many of the requested fields regarding AI performance evaluation are irrelevant.

Ask a specific question about this device