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SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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

The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.

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

The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.

The provided document is a 510(k) premarket notification for "Healing Abutments and Cover Screws." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of rigorous, large-scale studies typically associated with AI/ML-based medical devices or novel technologies.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission. This document describes a change in the sterilization method for existing devices, not a new device with performance metrics that require extensive clinical validation studies beyond sterilization and biocompatibility.

Here's an analysis based on the information available in the document:

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

For a 510(k) submission concerning a change in sterilization method for mechanical components like healing abutments and cover screws, the "acceptance criteria" revolve around demonstrating that the new sterilization method achieves the required sterility assurance level and does not adversely affect the device's material properties or function, maintaining its substantial equivalence to the predicate.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance data typical for AI/ML devices. The "tests" here are primarily engineering and laboratory validations:
  • Sterilization Validation: ISO 11137 standards define the number of units and replicates required for sterility testing (e.g., bioburden determination, dose mapping, sterility testing), which are often small, specific lots. This is standard laboratory validation, not a patient-based test set.
  • Aging Studies: ASTM F1980 dictates sample sizes for accelerated aging, again, laboratory testing of physical samples.
  • Biocompatibility: Relies on a prior submission (K041368) which presumably included its own biocompatibility testing. No new "sample size" for a clinical test set is mentioned for biocompatibility here.
• Data Provenance: The studies are laboratory-based ("Non-clinical testing data"). The manufacturer is located in the Republic of Korea (Dentium Co., Ltd.). The data would be derived from their internal validation processes. It is neither retrospective nor prospective in the sense of patient studies.

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

• Not Applicable. This submission does not involve image interpretation or clinical diagnosis where expert ground truth would be established. The "ground truth" for sterilization is a defined SAL, verified by microbiological and physical testing per ISO standards. The "ground truth" for material properties is based on ASTM standards and prior biocompatibility data.

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

• Not Applicable. As there is no clinical "test set" based on human interpretation or an AI algorithm's output requiring adjudication, this concept does not apply.

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 is a traditional medical device (dental implants and accessories), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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 an algorithm.

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

• The "ground truth" for this submission is based on:
  • Standardized Sterility Assurance: Achieving a defined SAL of 10^-6, verified through validated sterilization processes and testing compliant with ISO 11137-1 and ISO 11137-2.
  • Material Standards: Biocompatibility established against Ti-6Al-4V ELI (ASTM F136) as per regulations and previous submissions.
  • Engineering Performance: Shelf-life demonstrated through accelerated and real-time aging studies per ASTM F1980.
  • Substantial Equivalence: Demonstrated by comparing engineering specifications and intended use against legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This involved physical device manufacturing and validation, not machine learning model training.

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

• Not Applicable. (See point 8)

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

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

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

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

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

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

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

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

Here's what can be extracted and what cannot:

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

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

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

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific "test set" in the context of an AI/ML model for performance evaluation is described. The performance data relates to material properties and sterilization, not diagnostic/AI performance on a dataset.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not a concept for these mechanical/material devices.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with material standards, sterilization standards, and functional equivalence to predicates.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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

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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

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This document is a 510(k) clearance letter for "Dentium Implantium® & SuperLine® Prosthetics." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets them.

The letter primarily focuses on:

• Confirming the substantial equivalence determination.
• Outlining regulatory compliance requirements for the manufacturer.
• Identifying the product code and classification.
• Stating the intended use of the device ("intended for use as an aid in prosthetic rehabilitation").

Therefore, I cannot provide the requested information based on the text provided. This type of regulatory document typically follows the completion of such studies, but does not detail the studies themselves.

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Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.

Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.

The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
• Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.

7. Type of Ground Truth Used

• The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.

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

• This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.

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Implantium II is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient is chewing function. Implantium II is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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I am sorry but this document is a 510(k) clearance letter from the FDA for a dental implant (Implantium II). It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. This document is primarily an administrative letter confirming that the device is substantially equivalent to legally marketed predicate devices.

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Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

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This document is a 510(k) premarket notification acceptance letter from the FDA to Dentium Co., Ltd. for their Dentium NR Line CAD/CAM Abutments. It is not a study report or clinical trial report.

Therefore, the document does not contain any information about:

• Acceptance criteria and reported device performance (in the context of clinical or performance studies)
• Sample sizes used for test and training sets
• Data provenance (country of origin, retrospective/prospective)
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Types of ground truth used
• How ground truth was established for training sets

The letter merely states that the FDA has reviewed the 510(k) submission and determined the device to be "substantially equivalent" to legally marketed predicate devices, allowing Dentium to market the device subject to general controls. It refers to the device's "Indications for Use" (which are provided on the last page) but does not detail any studies conducted to prove the device meets performance criteria.

To answer your request, a different type of document, such as a clinical study report or a 510(k) summary (which often briefly describes performance data), would be needed. This document is purely an acceptance letter based on regulatory review, not a scientific study report.

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SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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This document is a 510(k) clearance letter for a dental implant device called "SuperLine." It mostly contains regulatory information and does not describe any specific studies or performance criteria in the detail requested. The 510(k) process primarily confirms substantial equivalence to a predicate device, not necessarily extensive clinical performance testing with defined acceptance criteria in the manner of a new drug or novel medical device requiring broad clinical trials.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, AUC, or similar statistical measures. The 510(k) clearance process often relies on testing for substantial equivalence, which may involve bench testing and comparisons to a predicate device's design and materials, rather than detailed clinical performance metrics with defined acceptance criteria against a ground truth as would be seen in AI/CADe device submissions.

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

• Not specified. The document does not describe a clinical test set or its provenance.

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

• Not specified. The document does not describe a test set or ground truth establishment.

4. Adjudication method for the test set:

• Not specified. The document does not describe a test set or 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 an endosseous dental implant, not an AI or CADe system designed to assist human readers. Therefore, an MRMC study with AI assistance is not relevant to this product.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used:

• Not specified. The document does not describe any ground truth. For a physical implant, "ground truth" related to its performance would typically involve measures of biocompatibility, mechanical strength, osseointegration, and clinical success over time, which are implied by substantial equivalence to a predicate device rather than explicitly detailed here.

8. The sample size for the training set:

• Not applicable/Not specified. This document is for a physical medical device, not an AI model requiring a training set.

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

• Not applicable/Not specified. This document is for a physical medical device, not an AI model.

In summary: The provided document is a regulatory clearance letter for an endosseous dental implant. It confirms the device's substantial equivalence to a legally marketed predicate device, enabling its market access. It does not contain the kind of detailed study design, acceptance criteria, or performance data typically associated with a new AI/CADe device or a clinical trial report. The information requested aligns more with performance evaluations of diagnostic software or AI-powered medical devices.

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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:

• Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
• Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
• Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
• Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.

The provided text does not contain:

• Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
• Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
• Details about training sets for an AI/ML model.

Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).

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The NR Line Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NR Line Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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Unfortunately, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text.

The document is a 510(k) premarket notification letter from the FDA regarding the "NR Line Implant System." This type of document primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria, detailed study designs, performance metrics of the device itself (beyond its indications for use), sample sizes for testing or training, expert qualifications, adjudication methods, or specific comparative effectiveness study results.

The letter focuses on regulatory compliance, outlining responsibilities under the Act (like registration, labeling, adverse event reporting, and good manufacturing practices). The "Indications for Use" section describes how the device is intended to be used, but this is not a performance study or a list of acceptance criteria.

To provide the information you're asking for, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of the full 510(k) submission but is not included in this letter), a clinical study report, or a detailed device specification document.

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