Search Results

PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject devices are Medentika CAD/CAM Abutments, which primarily expand the options for fabricating patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow". This workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machines, and associated tooling and accessories. The devices include Titanium Base abutments, Titanium base ASC Flex abutments, and PreFace and TI-Form (blanks) abutments.

The abutments are made of titanium alloy (Ti-6Al-4V ELI). Titanium base abutments also include a zirconia superstructure. The specified zirconia materials for milling superstructures are Ivoclar Vivadent IPS e.max ZirCAD Prime, Ivoclar Vivadent IPS e.max ZirCAD Prime Esthetic, Amann Girrbach Zolid Bion, Amann Girrbach Zolid Gen-X, and Institut Straumann AG n!ce Zirkonia HT. The specified cement for bonding superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG.

Key design parameters for CAD/CAM zirconia superstructures (on Titanium base and Titanium base ASC Flex) include: minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm for single unit restorations, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of the final abutment of 30°.

PreFace and TI-Forms abutments (blanks) are used by dental laboratories to fabricate customized abutments from titanium alloy. Their design parameters include: minimum wall thickness of 0.4 mm, minimum cementable post height of 4.0 mm, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of 30°.

Prosthetic-level components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are provided for use with previously cleared Medentika multi-unit abutments and MedentiBASE abutments.

All abutments are provided non-sterile with appropriate abutment screws. The screws attach the abutment to the implant or the prosthesis to the abutment.

The provided 510(k) clearance letter and summary describe a medical device, Medentika CAD/CAM Abutments, and its substantial equivalence to predicate devices based on non-clinical performance data. The document does not contain information about acceptance criteria or performance data for an AI/ML-based device, nor does it detail a clinical study involving human readers or expert consensus for ground truth.

Therefore, for the information requested in your prompt, I can only extract what is presented in the document, which pertains to the non-AI aspects of device acceptance and testing. Many of the points specifically refer to AI/MRMC studies, which are not applicable to this document.

Here's an analysis based on the provided text:

Device Description and Purpose:
The device is "Medentika CAD/CAM Abutments," which are dental implant abutments. The primary purpose of this submission is to expand the fabrication options for patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow" that integrates CAD/CAM software and milling machines. It also adds new sizes and OEM compatibilities.

Study Type:
This is a pre-market notification (510(k)) submission seeking substantial equivalence to existing legally marketed devices. It relies heavily on non-clinical performance data to demonstrate that the new manufacturing workflow and expanded compatibilities do not raise new questions of safety or effectiveness.

Analysis of Requested Information (based on the provided document):

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

The document outlines various performance tests conducted to demonstrate substantial equivalence, but it does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance." Instead, it states that the tests demonstrate sufficient strength or ensure accuracy and reliability.

Here's a summary of the performance tests and their implied purpose:

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

• Sample Size for Test Set: The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., how many abutments were mechanically tested, how many software validation tests were run). It simply states that "testing was conducted" or "validation was performed."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of pre-market non-clinical testing for medical devices, these are typically prospective laboratory tests conducted by the manufacturer or accredited testing facilities. The manufacturer is Medentika® GmbH (Huegelsheim, Germany), suggesting the testing likely occurred in Germany or at internationally recognized labs.

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

This information is not applicable to the provided document. The ground truth for this device is established through engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, not through human expert consensus on diagnostic images.

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

This information is not applicable to the provided document, as it describes non-clinical engineering and manufacturing validation, not a multi-reader clinical study for AI.

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 to the provided document. This device is a physical dental abutment and its associated CAD/CAM workflow, not an AI-based diagnostic tool that would require human reader studies. The document explicitly states: "No clinical data were included in this submission."

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

This information is not applicable to the provided document. While the device utilizes CAD/CAM software and milling machines, it is a physical product manufactured through a workflow, not a standalone AI algorithm whose performance needs to be assessed in isolation. The software functions as a design and manufacturing aid, not a diagnostic or decision-making algorithm.

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

The "ground truth" in this context refers to established engineering and material standards:

• Standards Compliance: Adherence to ISO standards (e.g., ISO 14801 for mechanical strength, ISO 10993 for biocompatibility, ISO 17665 for sterilization).
• Dimensional Accuracy: Verification against established design parameters and compatibility specifications for dental implants (e.g., OEM implant body and abutment dimensions).
• Material Specifications: Conformance to ASTM F136 for titanium alloy and specifications for zirconia and cement.
• Software Design Parameters: The "ground truth" for the CAD software validation is the pre-defined maximum and minimum design parameters that the software must enforce.

8. The sample size for the training set:

This information is not applicable to the provided document. The "device" in question is a physical dental abutment and its manufacturing workflow, not an AI/ML model that requires a training set. The CAD/CAM software itself is validated, not "trained" on a dataset in the AI sense.

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

This information is not applicable to the provided document for the same reasons as point 8.

Ask a specific question about this device

CARES® Screw-retained Bars and Bridges are prosthetic components directly connected to the endosseous dental implant as an aid in prosthetic rehabilitations.

CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. CARES® Screwretained Bridges and Bars are indicated for screw-retained restorations.

CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant systems (Implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)):

Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0 Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4

Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0)

Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0

Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0, 5.0 / Platform 3.4, 4.1, 5.0

Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0

Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1

Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7

Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0

Dentsply Implants – XiVE S / T- Series / Diameter 3.4. 3.8. 4.5. 5.5 / Platform 3.4. 3.8. 4.5. 5.5

The CARES® Screw Retain Bars and Bridges, referenced in Table 1, are used for the restoration of different dental implants systems with different endosteal diameters, lengths and platforms. The bars and bridges presented in the premarket notification submission (identified as "SRBB" for Screw Retained Bridges and Bars) are designed to interface with different implant connections. They allow for individual customization regarding function and esthetics. They attach directly to dental implants. The devices are intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. Screw Retained Bars and Bridges (SRBB) devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e. they are designed by a dental professional (clinician or dental technician) and fabricated by Medentika specifically for an individual patient. SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Commercial Off-The-Shelf (COTS) Software includes the ability to generate digital restoration models incorporating the subject devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)-techniques. The devices are made entirely of titanium Grade 5 according to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The document provided is a 510(k) summary for a medical device (CARES® Screw - Retained Bars and Bridges) and does not contain information about the acceptance criteria and study proving a device meets them. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a report of comprehensive performance testing with specific acceptance criteria and detailed study results.

The document discusses performance testing in a general sense, stating that dynamic fatigue testing was conducted according to FDA guidance and demonstrated equivalence to predicate and reference devices. However, it does not provide specific numerical acceptance criteria or the reported device performance against those criteria.

The following information from your request cannot be provided based on the given document:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish the ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm-only) performance results
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document mentions that dynamic fatigue testing was performed according to FDA guidance and that "Reverse Engineering Analysis" was conducted for certain implant compatibilities. For the GM-Series, implant connections were shared through a business partnership. The change in design workflow did not require additional testing as design parameters are identical and respected by trained technicians.

In summary, the provided text confirms that performance testing was conducted, but it does not detail the acceptance criteria or specific results, nor does it describe a study in the format typically required for your request.

Ask a specific question about this device

MINICONE are dental implants that are intended for the stabilization of removable dentures.

MINICONE Implants ø2.6 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.

For mandibular restorations, at least 4 MINICONE Implants should be placed.

For maxillary restorations, at least 6 MINICONE Implants should be placed.

MINICONE consists of 2 MINICONE tapered implants with an external diameter of 2.6 mm and lengths of 10 and 12 mm, as well as related accessories.

The implants are manufactured utilizing Titanium Grade 5 ELI material (Ti-4Al-6V) and are finished with a roughened surface (sandblasted/acid etched). The implant neck is machined, and the attachment element of the implants is acting as a retention feature for dentures. This retention feature is coated using a Titanium Nitride (TiN) to obtain a more wear resistant surface and has the Optiloc® geometry which is connected to the denture.

MINICONE Implants Ø2.6mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.

The implants can be placed with immediate function when good primary stability is achieved. The MINICONE implants are intended for the stabilization of removable dentures. The removable dentures are connected to the MINICONE implants through the incorporated Optiloc® attachment element.

The provided document is a 510(k) summary for the MINICONE Implant, a dental device. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The information provided is for a traditional medical device, specifically an endosseous dental implant, and focuses on performance testing for mechanical properties and sterilization.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted from the document:

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 provided in the document. The document describes the types of engineering and mechanical tests performed (insertion torque, wear, fatigue), but does not specify sample sizes for these tests, nor the "data provenance" in the context of clinical/imaging data as typically asked for AI 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)

This information is not applicable as the document describes performance testing for a physical medical device (dental implant), not an AI algorithm that requires expert ground truth for interpretation of images or other data.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm requiring adjudication of interpretations.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that would be used in conjunction with human readers.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm.

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

This information is not applicable in the context of AI studies. For the engineering tests performed:

• Insertion Torque, Wear, Fatigue: Ground truth is established by measured physical properties against established industry standards (e.g., ISO 14801) and comparison to predicate devices, rather than expert consensus on interpretations of data.
• Biocompatibility: Ground truth is based on the known, previously cleared status of the materials (Titanium Grade 5 ELI and TiN coating).
• Sterilization: Ground truth is established by validated processes against microbiological standards (SAL of 10-6 according to ISO 11137-1 and -2).
• Shelf Life: Ground truth is established by accelerated aging tests projecting real-time performance.

8. The sample size for the training set

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set with ground truth.

Ask a specific question about this device

Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
Medentika series EV-Series, Implant system Dentsply® Implants - ASTRA TECH OsseoSpeed®, Implant diameter 3.6, 4.2, 4.8, Platform diameter 3.6, 4.2, 4.8
Medentika series F-Series, Implant system Nobel Biocare NobelActive - NobelReplace Conical, Implant diameter 3.5, 4.3, 5.0, Platform diameter NP 3.5, RP 4.3/5.0
Medentika series H-Series, Implant system Biomet 3i - Certain, Implant diameter 3.25, 4.0, Platform diameter 3.4, 4.1
Medentika series L-Series, Implant system Straumann - Bone Level, Implant diameter 3.3, 4.1, 4.8, Platform diameter 3.3, 4.1, 4.8
Medentika series N-Series, Implant system Straumann - Soft Tissue Level, Implant diameter 4.1, 4.8, Platform diameter 4.8, 6.5
Medentika series R-Series, Implant system Zimmer Dental Tapered Screw-vent, Implant diameter 3.3, 3.7, 4.1, 4.7, Platform diameter 3.5, 4.5

The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.

The provided document is a 510(k) premarket notification for "Multi-unit Abutments." This document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing. However, it does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in a diagnostic or interpretive context.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" outlined in the request (e.g., MRMC study, ground truth, expert consensus, sample size, effect size) are typically attributes of studies supporting AI/ML-driven medical devices that output a diagnostic or interpretive result. The device described in this 510(k) is a physical dental implant component, not a software or AI device.

Therefore, I cannot extract the requested information regarding AI/algorithm performance. The provided text outlines:

• Device Description: Multi-unit abutments are dental components screwed onto implants to support prosthetic suprastructures (e.g., bridges, bars).
• Performance Testing: This refers to mechanical and biological testing (e.g., dynamic fatigue, static strength, biocompatibility, sterilization) to ensure the physical device's safety and effectiveness, not the performance of an AI algorithm.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new device is as safe and effective as previously cleared predicate devices through comparisons of indications for use, design, materials, and mechanical properties.

Specifically, here's why the requested information cannot be provided from the text:

1. Acceptance Criteria/Reported Device Performance (Table): The document provides a table of "Technological Characteristics" comparing the subject device to predicates, but these are design and material specifications, not performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
2. Sample Size and Data Provenance: Not applicable for an AI test set. The document discusses "test sets" in the context of mechanical fatigue and static strength tests (e.g., testing multiple abutment units), but not a dataset of images or patient cases for AI evaluation.
3. Number of Experts/Ground Truth Establishment/Qualifications: Not applicable. There's no AI component requiring expert review for ground truth.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This device is a physical component, not an AI assisting human readers.
6. Standalone Performance: Not applicable. There is no AI algorithm to evaluate in standalone mode.
7. Type of Ground Truth Used: Not applicable. Ground truth for an AI would involve labeled data (e.g., disease presence/absence from pathology), which is irrelevant for a dental abutment.
8. Sample Size for Training Set: Not applicable.
9. Ground Truth for Training Set: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (dental abutments), which successfully demonstrates substantial equivalence based on engineering and biocompatibility standards. It does not involve any artificial intelligence or machine learning component, and thus the acceptance criteria and study details relevant to AI performance are absent.

Ask a specific question about this device