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

TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

The purpose of this submission is to obtain marketing clearance for TRI-matrix X-Force implants, a line extension of the TRI-matrix implant line previously cleared in K203660. TRI-matrix X-Force implants are tissue-level endosseous dental implants that are an adaptation of the TRI-matrix Tissue Level implants cleared in K203660, with the same prosthetic interface, but with modified external features. They are intended for use in the mandible or maxilla to restore chewing function. This submission includes only implants, and they are compatible with prosthetic components previously cleared in K203660 as part of the TRI-matrix implant line, including the TRI-matrix Crown Abutment.

TRI-matrix X-Force implants have a tapered body, double-lead threads and self-cutting flutes. A gritblasted and acid-etched surface, named the TRI SBA Surface, is applied to the endosseous portion of the implant. TRI-matrix X-Force implants incorporate a pink anodized, machined, 1.8 mm transgingival collar that is not treated with the TRI SBA Surface. Compared with TRI-matrix implants previously cleared in K203660, TRI-matrix X-Force implants have a modified thread design more suited to immediate placement and restoration, a more tapered apical portion (smaller apical diameter for a given coronal diameter), and more aggressive apical cutting flutes.

TRI-matrix X-Force 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix X-Force 3.7 mm and 4.1 mm diameter implants are available in two (2) platform diameters: 3.7 mm and 4.5 mm. TRI-matrix X-Force 4.7 mm diameter and 5.7 mm diameter implants have a platform diameter of 4.5 mm.

This document describes the marketing clearance for medical devices and does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics or clinical outcomes.

The document discusses the substantial equivalence of the TRI-matrix® X-Force Implants to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. This type of submission (510(k)) generally does not require proof of meeting specific performance acceptance criteria through the kind of studies you've outlined.

Specifically, the "PERFORMANCE DATA" section states:

• "Non-clinical data submitted to demonstrate substantial equivalence included: Referenced from the primary predicate device K203660: sterilization validation according to ISO 17665-1 and ISO 17665-2; . Provided in this submission: biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform. No clinical data were included in this submission."

Therefore, I cannot provide the requested information for the following reasons:

1. Table of acceptance criteria and reported device performance: This document does not specify general "acceptance criteria" for clinical performance or report clinical performance data. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and design comparisons.
2. Sample size used for the test set and data provenance: No clinical test set was used or described. The non-clinical testing involved "worst-case analysis and static and dynamic testing according to ISO 14801," but specific sample sizes for these engineering tests are not detailed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set or ground truth determination by experts is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical studies were included.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device (dental implant), not an AI algorithm.
7. Type of ground truth used: Not applicable, as no clinical data or ground truth determination is described.
8. Sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The DenQ Sub SLA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile.

The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling).

This document is a 510(k) Pre-market Notification for a dental implant system (DenQ Sub SLA Implant System). It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets acceptance criteria through clinical or comparative effectiveness studies in the typical sense of a novel AI/software device.

Therefore, many of the requested elements (like MRMC studies, number of experts for ground truth, training set information for an AI device) are not applicable to a 510(k) submission for a physical dental implant system. The "acceptance criteria" here refers to demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and comparison of characteristics.

Here's a breakdown of the available information relevant to your request, adapting it to the context of this specific document:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

For a physical device like a dental implant, "acceptance criteria" are the relevant ISO standards and material specifications that the device must meet to be considered safe and effective and substantially equivalent to a predicate. The "reported device performance" is the demonstration that these tests were passed.

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

This document is for a physical medical device, not an AI/software device that would typically have a "test set" of patient data. The "tests" here refer to laboratory and bench testing on the physical device components.

• Sample Size: Not specified for individual non-clinical tests (e.g., how many implants were subjected to fatigue testing). This information is typically detailed in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: Not applicable in the sense of patient data. The results are from in-vitro (laboratory) and bench testing of the devices themselves. The tests were performed "in accordance with ISO standards and US regulations." The manufacturer is located in the Republic of Korea.

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

• Not applicable. This submission relies on engineering standards and laboratory measurements for its performance criteria, not expert interpretations of medical images or clinical data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" requiring adjudication in the context of this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done (and effect size):

• No. MRMC studies are typically for diagnostic AI devices assessing human reader performance. This is a physical dental implant.
• Summary of clinical testing: "No clinical testing was performed for this submission."

6. 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.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established by engineering and material standards (e.g., ISO, ASTM, USP), and the physical measurements and observations derived from in-vitro and bench testing of the device's components (e.g., fatigue resistance, material properties, sterility).

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data.

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

• Not applicable. As above, no training set.

Ask a specific question about this device

BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

Ask a specific question about this device