Search Results

ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.

ITI implants have an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasma-sprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths.

This document is a 510(k) Summary for the ITI® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific acceptance criteria or device performance data for this product.

Therefore, I cannot fully answer your request based on the provided text. The document states:

"The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle."

This indicates that the submission is for a device that is essentially the same as a previously cleared one, and as such, detailed performance studies with acceptance criteria are typically not required. The basis for substantial equivalence is the identity of the device to its predicate.

However, I can extract information related to the device and its regulatory context:

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

• Not applicable. The document does not describe acceptance criteria or reported device performance for a new study. Instead, it asserts that the device is identical to previously cleared devices.

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

• Not applicable. No test set or data provenance is mentioned as no new performance study was conducted.

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. No ground truth establishment for a test set is discussed.

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

• Not applicable. No test set or adjudication method is described.

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

• Not applicable. This document pertains to dental implants, not AI-assisted reading or diagnostic devices.

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

• Not applicable. This document pertains to dental implants, not algorithms.

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

• Not applicable. No new ground truth was established as no new performance study was described.

8. The sample size for the training set

• Not applicable. No training set for a new study is mentioned.

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

• Not applicable. No training set or ground truth establishment is described.

Summary of what the document does indicate:

• Device Name: ITI® Dental Implant System
• Indications for Use: Surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients, for single-stage or two-stage surgical procedures.
• Predicate Devices: ITI Dental Implant System and Implant Innovations Inc. Osseotite Dental Implants (K013570).
• Basis for Substantial Equivalence: The device is identical in intended use, material, surface treatment, design, and operating principle to previously cleared ITI implants. The contraindication regarding tobacco use has also been removed, aligning with the predicate Implant Innovations Inc. Osseotite Dental Implants.
• Device Components: Grade 4 titanium (cold worked), grit blasted and acid-etched (SLA surface) or titanium plasma-sprayed (TPS surface) anchorage surface, smooth machined neck. Available in diameters from 3.3 to 4.8 mm and various lengths.
• Regulatory Classification: Class III, Product Code DZE, Regulation Number 21 CFR 872.3640 (Endosseous Implants).

Ask a specific question about this device

The ITI dental implants are intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

ITI solid screw implants have an external spiral screw thread and an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasmasprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths.

The provided text is a 510(k) Summary for a medical device (ITI® Dental Implant System). It claims substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance studies.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this specific device's approval is not present in the provided document.

The document states:
"The subject ITI® dental implants are identical in intended use to currently marketed ITI® dental implants, and the indications for use covered in this 510(k) are the same as that of the predicate Branemark system dental implants. The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle."

This explicitly indicates that the approval is based on substantial equivalence to existing devices that have already met regulatory requirements, not on new performance studies for this iteration of the device.

Ask a specific question about this device

ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

The ITI tapered implant is an addition to the currently distributed ITI Dental Implant System. The tapered implant is a solid screw with a TPS (titanium plasma sprayed) coating or an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and is available in a range of lengths and diameters. This submission also includes abutments and healing caps which are used as accessories to dental implants.

The provided documentation describes a 510(k) premarket notification for the ITI® Dental Implant System, specifically the ITI tapered implant. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria. Therefore, several aspects of your request, such as specific acceptance criteria and detailed study results, cannot be fully addressed from the given text.

Based on the provided information, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" in this context are primarily based on demonstrating substantial equivalence to predicate devices, as this is a 510(k) submission. Therefore, the "reported device performance" is essentially the applicant's claim and the FDA's concurrence that the new device meets the criteria for substantial equivalence in terms of intended use, materials, design, and surface treatment. No specific quantitative performance metrics from a formal study are provided in this document.

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

This document describes a 510(k) submission for substantial equivalence. It does not present a clinical study with a "test set" or data provenance in the way one would for a new clinical efficacy or safety trial. The assessment is based on a comparison to existing predicate devices and their known performance, along with material and design similarities.

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

Not applicable. This document does not describe the establishment of a "ground truth" through expert review for a clinical test set. The "ground truth" for a 510(k) is effectively the established safety and efficacy profile of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described in this document.

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

No. This document does not mention or present any MRMC comparative effectiveness study, nor does it discuss AI assistance in the context of human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This document is about a physical dental implant device and does not involve an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness profile of the legally marketed predicate devices (ITI Self-Tapping Implants K003271 and ITI Temporary Abutment K990342). The new device's characteristics (intended use, materials, design, surface treatment) are compared against these known, approved devices to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm submission.

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

Not applicable. There is no training set described in the document.

In summary: This 510(k) document is a regulatory submission focused on demonstrating that a new dental implant (ITI tapered implant) is substantially equivalent to existing, legally marketed predicate devices. It achieves this by showing identical intended use and similar material composition, surface treatment, and design. It does not present data from a new clinical study with acceptance criteria, test sets, or ground truth establishment as would be seen in a clinical trial report or an AI device submission.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.

Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.

Ask a specific question about this device

ITT dental implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided text describes a 510(k) summary for the ITI Dental Implant System, which is a medical device submission to the FDA. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Applicant and device identification.
• Declaration of substantial equivalence to previously cleared devices (K894593, K894595, K971578, K954512, K960288, K954347, K960417).
• Description of the device (materials, design, surfaces).
• Intended use (supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients).
• FDA's response letter acknowledging the 510(k) submission and permitting market entry based on substantial equivalence.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

For a 510(k) submission, the "proof" often comes from demonstrating that the device is substantially equivalent to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance testing is usually conducted to support the substantial equivalence claim, the specifics of such tests (acceptance criteria, results, expert reviews, sample sizes) are not detailed here.

Ask a specific question about this device