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The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.

The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.

Here is an analysis of the provided text regarding the acceptance criteria and study for the IMTEC MDI MII One-Piece Implant:

The document is a 510(k) Premarket Notification for the IMTEC MDI MII 2.9mm One-Piece Implant. As such, the purpose is to demonstrate substantial equivalence to predicate devices, not to establish new performance acceptance criteria through clinical trials. The "acceptance criteria" here refers to the demonstration of safety and effectiveness through equivalence, rather than specific performance metrics validated by a clinical study against a predefined threshold.

Based on the provided text, a formal study with detailed acceptance criteria and reported device performance in the way a clinical trial would typically be structured does not appear to have been conducted for this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The "acceptance criteria" here is fundamentally about demonstrating that the new device is as safe and effective as a legally marketed predicate device, not about meeting specific numerical performance targets established through a de novo clinical study.

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

• Sample Size for Test Set: Not specified in the provided text for "performance testing." The text mentions "performance testing conducted by the University of Georgia" and "Laboratory testing by the Medical College of Georgia," but no details on the sample size (number of implants tested, number of tests performed) are given.
• Data Provenance:
  • Country of Origin: USA (University of Georgia, Medical College of Georgia).
  • Retrospective or Prospective: Unspecified. However, for laboratory performance testing in a 510(k) submission, it would generally be prospective testing of the device prototypes/samples.

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

Not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through comparison to predicate devices, adherence to recognized standards (implied by the "performance testing"), and the scientific principles behind dental implant design and materials, rather than expert consensus on a test set.

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

Not applicable. This type of adjudication method is typically used in clinical trials or studies where human readers/evaluators are assessing outcomes or images against a "ground truth" established by multiple experts. The document describes laboratory performance testing and comparison to predicates, not a reader study.

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 510(k) for a physical dental implant, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices. The new device is considered safe and effective if it can demonstrate substantial equivalence to these predicates through comparison of:

• Intended use
• Technological characteristics (including materials, design, size, etc.)
• Performance (demonstrated through laboratory testing where similarities are not direct)

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) for a physical device like this. Training sets are typically used for machine learning algorithms.

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

Not applicable, as there is no training set.

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ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.

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I am sorry, but the provided text does not contain information regarding objective acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA, confirming that the device, ILUMA Vision v2.0, is substantially equivalent to a legally marketed predicate device.

The letter mentions the device's intended use and the regulatory classification but does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any studies.
• Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
• Data on standalone algorithm performance.

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The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.

x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence

The provided text is a 510(k) clearance letter from the FDA for the ILUMA OrthoCat/DentalCat device. This document primarily focuses on the regulatory approval process and does not contain the specific details about acceptance criteria, study design, or performance metrics that would typically be found in a study report or a more detailed section of a 510(k) submission.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets those criteria from the provided text. The document confirms that the device is substantially equivalent to a predicate device but does not elaborate on the specific performance studies conducted to demonstrate this equivalence in terms of detailed metrics, sample sizes, ground truth establishment, or expert reviews.

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To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodontic appliance in the mandible or maxilla.

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The provided text is a heavily redacted FDA 510(k) clearance letter for the "ENDURE Implant System." This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information as requested in the prompt.

The document states that the "device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means that the FDA did not require new clinical studies demonstrating safety and effectiveness for this device, but rather assessed its similarity to existing, legally marketed devices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study data because this information is not present in the provided text.

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Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.

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The provided text is a 510(k) clearance letter from the FDA for the (MDI ORTHO) Endosseous Implant. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain the kind of detailed information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This letter is a regulatory clearance document, not a scientific study report. It states that the device is substantially equivalent to a predicate, which means the FDA believes it is as safe and effective as a device already on the market. The specific studies and data supporting that determination are typically submitted in the full 510(k) submission, which is not provided here.

Therefore, I cannot populate the requested information from the given text.

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LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for LEAATTE QUORTAON crowns, bridges, inlays and onlays.

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The provided text is a 510(k) clearance letter from the FDA for a dental resin called "Lexatite Quick Acrylic." This letter approves the device for market based on substantial equivalence to a legally marketed predicate device.

It does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a detailed 510(k) summary.

The letter focuses on the regulatory determination of substantial equivalence, which is a comparison to a predicate device, not on meeting specific performance metrics through a new study.

Therefore, I cannot provide the requested information. The document explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act..."

To answer your questions, I would need a different type of document, such as a 510(k) summary that details the performance data or a clinical study report.

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The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.

self-tapping titanium threaded screws

The provided text is a 510(k) premarket notification letter from the FDA regarding the "IMTEC Sendax MDI and MDI PLUS" dental implants. This document does not contain information about acceptance criteria, study methodologies, or performance metrics for an AI/CADe device.

Therefore, I cannot provide the requested information. The text is a regulatory clearance document, not a scientific study report.

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To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodentic appliance in the mandible or maxilla.

ENDURE endosseous implant

This document is a 510(k) clearance letter for the ENDURE Endosseous Implant. It confirms that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include detailed information about clinical trials, performance metrics, ground truth, or expert qualifications in the way you've requested.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than extensive clinical studies with specified acceptance criteria as one might see for novel, high-risk devices or software as a medical device (SaMD).

Therefore, based solely on the provided text, I cannot fill in the requested table and information. Most of the points you've asked for are related to clinical studies and performance evaluation that are not typically included in a 510(k) clearance letter itself.

To answer your questions, one would need to access the full 510(k) submission (if publicly available or by contacting the manufacturer), which would contain the detailed test reports and justification for substantial equivalence.

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To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.

Saber Tech Implants System (GIS) endosseous implant

The provided text is a 510(k) premarket notification letter from the FDA to IMTEC Corporation regarding their Saber Tech Implants System (GIS) Endosseous Implant. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was approved based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a clinical trial report or a performance study.

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