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 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

The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
  • · CONELOG® Implant System
• · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
  • · TSXTM Implants
  • · Tapered Screw-Vent Implant
• · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
  • · 3i OSSEOTITE®
  • · Astra Tech OsseoSpeed™
  • · Neodent Grand Morse
  • NobelReplace® Trilobe
  • · NobelReplace® Conical
  • · Nobel Brånemark System®
  • · Straumann BLX Implants
• · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
  • · NobelActive® NobelParallel Conical
  • Straumann® Bone Level
  • · Zimmer Screw Vent® and Tapered Screw-Vent®
• · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
• · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• KDG Abutments, 4.8mm, max 30°
• · Keystone Multi Unit Abutment, 4.8mm, 0°
• · Medentika Multi Unit Abutments, 4.8mm, max 30°
  • · EV Series Dentsply® Implants Astratech Osseospeed®
  • · F Series Nobel Biocare NobelActive® NobelReplace® Conical
  • · H Series Biomet 3i Certain®
  • L Series Straumann Bone Level
  • · N Series Straumann Soft tissue Level
  • · R Series Zimmer Dental Tapered Screwvent®
• Medentika Multi Unit Abutments, 4.8mm, 0°
  • E Series Nobel Biocare Replace™ Select
  • · I Series Biomet 3i Osseotite®
  • K Series Nobel Biocare™ Branemark
  • · S Series Astra Tech OsseoSpeedTM
  • · T Series Dentsply Friadent® Frialit/Xive®
• · MegaGen Multi Unit Abutments, 4.8mm, max 30°
• · Xpeed® AnyRidge® Internal Implant System
• AnyOne® Internal Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® External Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® Internal Implant System
• Rescue Internal Implant System
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
• · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
  • SS SA Fixture Implants
  • SA Implant System
  • · ET US SSS Prosthetic System
• · Paltop Multi Unit Abutment, 5.0 mm, max 17°
• · Southern Compact Conical Abutments, 4.8 mm
  • MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

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

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

• Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
  • Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
  • Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
• Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

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 requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

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

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

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 suprastructure, not an AI-powered 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 dental suprastructure, not an algorithm.

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

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

• Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
• Material specifications: Conformance to ASTM F136 for titanium alloy.
• Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this 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

-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

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

SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only.

This document describes the SNUCONE Bone Level Implant System, a dental implant system. The information provided outlines the device, its components, and a comparison to predicate devices for substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study would. Instead, it focuses on bench testing and adherence to recognized standards.

Here's an analysis of the provided text in relation to your request:

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

The document details various non-clinical tests and the standards they adhere to. However, it does not provide a table with specific quantitative acceptance criteria for each test and the numerical reported performance of the device against those criteria. It generally states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Here's a summary of the tests and the general statement of performance:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the non-clinical bench tests (e.g., number of implants tested for fatigue). It refers to standards like ISO 14801 which would dictate sample sizes, but the numerical value is not explicitly stated.
• Data Provenance (Country of Origin, Retrospective/Prospective): The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective. Given that these are non-clinical bench tests, the concept of "retrospective" or "prospective" as applied to clinical studies is not directly applicable.

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 information is not applicable to the provided document. The document describes non-clinical bench testing of a dental implant system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here refers to the physical and chemical properties and performance characteristics determined by the test methods outlined in the specified standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which is not the nature of the tests described in this document. The results of the mechanical, sterilization, MRI, endotoxin, and biocompatibility tests are determined by adherence to established, objective engineering and scientific standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This document describes a dental implant system, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

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

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

The "ground truth" for the non-clinical tests described is defined by the objective, measurable criteria within the referenced international and national standards (e.g., ISO 14801, ISO 17665, ASTM F1980, ANSI/AAMI ST72, ISO 10993). For example:

• Fatigue testing: The "ground truth" is whether the implant withstands a specified number of cycles at a certain load without failure, as defined by ISO 14801.
• Sterilization validation: The "ground truth" is achieving the required sterility assurance level (SAL), as defined by ISO 11737.
• Biocompatibility: The "ground truth" is that the material does not elicit adverse biological responses, as assessed by the tests specified in ISO 10993.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set for the reasons stated above.

Ask a specific question about this device