Search Results

The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.

The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.

The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.

The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.

The device is provided non-sterile to the user in medical grade packaging.

Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the XP1 Angled Abutments, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study on the XP1 Angled Abutments themselves.

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 as the document does not describe a performance study involving a test set that required expert-established ground truth. The primary method of demonstrating acceptance was substantial equivalence to previously cleared devices.

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

This information is not applicable as the document does not describe a performance study involving a test set that would require an adjudication method.

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. The device is an angled dental abutment, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

The document does not describe a study that required a "ground truth" in the typical sense for analytical or clinical performance evaluations. Instead, the "ground truth" for the device's acceptance was:

• Conformance to Industry Standards: The material composition (Ti-6AL-4V ELI conforming to ASTM F136) is a verifiable standard based on material science and engineering specifications.
• Substantial Equivalence: The primary "ground truth" for regulatory clearance was a comparison to predicate devices, meaning the regulatory body (FDA) determined the XP1 Angled Abutments were sufficiently similar in design principles, materials, and intended use as devices already legally marketed and deemed safe and effective.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set."

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

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set" or its associated ground truth establishment.

Summary of the "Study" for Acceptance:

The submission for the XP1 Angled Abutments (K090397) primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new clinical trials or extensive performance studies on the new device, the manufacturer demonstrated that the XP1 Angled Abutments were:

• Identical or substantially equivalent in intended use.
• Identical or substantially equivalent in material composition (Ti-6AL-4V ELI conforming to ASTM F136).
• Identical or substantially equivalent in design principles.

The FDA reviewed this comparison and a description of the device's characteristics to determine that it was as safe and effective as the predicate devices already on the market. The letter from the FDA confirms this determination of substantial equivalence, which is the "study" or justification for its acceptance into the market. No specific performance study with a test set, ground truth, or expert involvement as typically understood for software or diagnostic devices is described.

Ask a specific question about this device

The Olympus Dental Implant System is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability.

The Olympus Dental Implant System includes various sizes of parallel sided, threaded, root-form dental implants and straight abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stobility is reached according to the Instructions for Use, Olympus Dental Implants with an insertion depth of 8 mm or more may be immediately loaded. The system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components (Class 1 exempt, not a subject of this submission) intended to facilitate the prevaration of prosthetic restorations.

This document describes the Olympus Dental Implant System, which is a Class II medical device. The information provided outlines its intended use and describes its equivalence to already marketed devices, but it does not include a study describing acceptance criteria or performance metrics in the way one might find for a diagnostic or AI-driven device.

Therefore, I cannot populate the table or answer most of the questions as the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed test results.

Here's an explanation based on the provided text:

• Type of Device: The Olympus Dental Implant System is a physical dental implant system, not a diagnostic or AI-powered software device.
• Regulatory Pathway: The submission is a 510(k) premarket notification. This pathway primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for novel performance metrics.
• Lack of Performance Study Data: The provided text does not contain any sections detailing a study with acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. The "DEVICE DESCRIPTION" and "EQUIVALENCE TO MARKETED PRODUCT" sections confirm this focus on equivalence in design and indications for use.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission.
2. Sample size used for the test set and the data provenance: No performance study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study described.
4. Adjudication method for the test set: No performance study described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical implant, not an AI or diagnostic tool.
6. If a standalone performance (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: No training set for an algorithm described.
9. How the ground truth for the training set was established: No training set for an algorithm described.

Summary of available information:

• Device Name: Olympus Dental Implant System
• Intended Use: "To be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability."
• Regulatory Classification: Class II (Endosseous dental implant - 21 CFR 872.3640; Endosseous dental implant abutment - 21 CFR 872.3630).
• Equivalence: The manufacturer "demonstrated that... the Olympus Dental Implant System is substantially equivalent in indications and design principles to predicate devices."

The 510(k) process for devices like dental implants primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, materials testing, and comparison of design features, rather than extensive clinical performance studies with specific numerical acceptance criteria for diagnostic accuracy or algorithmic performance as would be seen for AI/ML devices.

Ask a specific question about this device

EasyGuide is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the EasyGuide treatment planning software.

Not Found

This FDA 510(k) clearance letter for the "EasyGuide" device, a software for pre-treatment planning of dental implants based on CT scans, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter is a notification of substantial equivalence to a predicate device, which means the FDA has determined it is as safe and effective as a legally marketed device. It does not typically include the in-depth technical performance characteristics or detailed study results that would satisfy your request for acceptance criteria and supporting study data.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance: This information is completely absent.
2. Sample size used for the test set and data provenance: No details on testing, sample sizes, or data origin are provided.
3. Number of experts used to establish ground truth and their qualifications: This is not mentioned.
4. Adjudication method for the test set: No information on this.
5. MRMC comparative effectiveness study details: This type of study is not mentioned or summarized.
6. Standalone (algorithm only) performance study details: Not present.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable, as this document is not about algorithm training or validation in that context.
9. How ground truth for the training set was established: Not applicable.

The letter focuses on the regulatory aspects of 510(k) clearance, such as product code, regulation number, substantial equivalence determination, and general controls. It refers to the "Indications for Use" for the device on the enclosed page, which is a high-level description of its intended use, but not performance specifications.

To obtain the information you're looking for, you would generally need to consult the actual 510(k) submission document itself, which contains the detailed testing and validation data provided by the manufacturer to the FDA. This summary letter does not include that level of detail.

Ask a specific question about this device