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. ITI Dental Implants are for single-stage or two-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

The ITI Standard PLUS implants are modifications of the currently distributed ITI Esthetic PLUS implants. The subject implant is a solid screw with an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and are available in a range of lengths and diameters.

The provided submission describes a medical device, the ITI® DENTAL IMPLANT SYSTEM (Standard PLUS implants), and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.

The document K033922 is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical efficacy or performance data against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: The ITI Standard PLUS implants are modifications of already distributed ITI Esthetic PLUS implants. They are solid screw implants with an SLA surface, made of Grade 4 commercially pure titanium, and available in various lengths and diameters.
• Intended Use: Surgically placed in maxillary/mandibular arches to support prosthetic restorations in edentulous or partially edentulous patients, for single-stage or two-stage surgery. Intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading.
• Substantial Equivalence: The key argument for market clearance is that the device is substantially equivalent to the previously cleared ITI Esthetic PLUS implants (K983742 and K030007) due to identical intended use, material composition, surface treatment, and almost identical design.

In summary, none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is present in the provided text. This type of information is typically part of a robust clinical study report, which is not included in this 510(k) summary.

Ask a specific question about this device

The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.

The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are titanium anqled copings for the ITI anterior implant.

The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping is adapted to the individual restoration.

This document describes a 510(k) premarket notification for a dental device, specifically a "Titanium coping for ITI anterior implant." The information provided in the document is for a traditional device submission and does not include any details on acceptance criteria or a study proving that a device meets such criteria.

The document states that the device is "substantially equivalent to previously cleared ITI copings," and its "intended use...is identical to the predicate copings." This suggests that the substantial equivalence was likely established through a comparison of material properties, design features, and intended use with the predicate devices, rather than through a performance study with specific acceptance criteria that would typically be associated with new or significantly modified medical devices, especially those involving AI or complex functionalities.

Therefore, your request for the following information cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided. The submission appears to be based on design and material comparisons, not performance testing on a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment relevant to AI/performance studies is mentioned.
4. Adjudication method 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-powered diagnostic or assistive 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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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

The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The copings and milling cylinders are used as part of the prosthetic restoration.

The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include an abutment, copings, and milling cylinders.

The provided document is a 510(k) summary for a medical device clearance, specifically an abutment for dental implants. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not a diagnostic device or a device that requires performance metrics in the way implied by the request.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a device already on the market, rather than needing to prove its performance against specific acceptance criteria through a clinical study.

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

To explain why the requested information isn't present:

• Acceptance Criteria & Reported Device Performance: This device is a mechanical component (an abutment for a dental implant). Its "performance" is implicitly tied to its structural integrity, biocompatibility, and functional fit, which are often addressed through material specifications, design comparisons, and potentially bench testing (mechanistic rather than clinical performance). The 510(k) summary states that the subject device has an "almost identical design" to the predicate, implying its performance should be similar.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Comparative Effectiveness Study, Standalone Performance, Type of Ground Truth, Training Set Size & Ground Truth Establishment: These points are all relevant to clinical studies evaluating the diagnostic accuracy or clinical effectiveness of a device, especially for AI/ML-driven or diagnostic/screening tools. This dental abutment is a prosthetic component, not a diagnostic or AI device, so these types of studies are not typically required for its clearance. The "study" here is the comparison to the predicate device, not a performance study as described in the request.

The core of this 510(k) submission is the statement: "The subject devices are substantially equivalent to previously cleared ITI abutments. The intended use of the subject abutment is identical to the predicate abutment. The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are the same." This is the basis for its clearance, not a detailed performance study with acceptance criteria.

Ask a specific question about this device

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.

The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.

The provided text is a 510(k) summary for a medical device (ITI Esthetic Ease Abutments) and does not describe acceptance criteria, a study proving device performance, or any of the other requested information related to an AI/ML-based device performance study.

The document is a regulatory submission for a dental implant abutment, outlining its description, intended use, and substantial equivalence to previously cleared predicate devices based on material and design specifications. It is a standard medical device clearance document, not a study report or performance evaluation in the context of AI/ML or a clinical trial with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include several prosthetic accessories (abutment, titanium temporary posts, plastic burnout copings, and titanium healing caps).

The provided text describes a 510(k) premarket notification for prosthetic accessories to the ITI Dental Implant System. It focuses on establishing substantial equivalence to previously cleared devices rather than on performing a new clinical study with acceptance criteria for a novel device performance.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable. The document is a regulatory submission demonstrating that the new devices are similar in design, material, and intended use to existing, legally marketed devices.

Here's a breakdown of the information that can be extracted based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain explicit acceptance criteria or reported device performance in the way you might find for a diagnostic or AI-driven device. The basis for acceptance is "substantial equivalence" to predicate devices, meaning the new devices are considered safe and effective because they are fundamentally the same as devices already on the market.

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

• Not Applicable. This submission is not based on a clinical study with a test set of patient data. It is a comparison of product specifications (materials, design, intended use) against predicate devices.

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

• Not Applicable. Ground truth in the context of a clinical test set is not established here. The FDA reviewers assess the substantial equivalence claim based on the provided documentation and their expertise in medical devices.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no test set or adjudication process as described for performance studies. The FDA's review process involves evaluation by agency experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is not mentioned or implied by the document. MRMC studies are typically used to assess the impact of a new diagnostic tool on human reader performance, which is not the purpose of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This refers to prosthetic accessories for dental implants, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

• Not Applicable. "Ground truth" as an outcome measure from a clinical study (e.g., pathology, long-term outcomes) is not the basis for this submission. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which these new devices are compared.

8. The Sample Size for the Training Set:

• Not Applicable. There is no training set mentioned, as this is not an AI/machine learning device or a clinical study.

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

• Not Applicable. See point 8.

In summary: This document is a regulatory submission seeking clearance for medical devices based on their substantial equivalence to existing devices. It does not describe a clinical study with specific performance acceptance criteria, test sets, or ground truth establishment as would be found for a novel diagnostic or therapeutic device undergoing a performance evaluation.

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