Search Results

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

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

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