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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.

The provided text is a 510(k) summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance results in the way commonly associated with AI/ML device evaluations.

Therefore, many of the requested categories for AI/ML study reporting cannot be directly extracted from this document, as they are not applicable to the type of information presented in a 510(k) for a physical medical device like a dental implant.

Here's an attempt to address the applicable points or explain why certain points cannot be answered based on the provided text:

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

This information is not provided in the document. For a physical device like a dental implant, acceptance criteria would typically relate to mechanical strength, biocompatibility, design specifications, and manufacturing quality. The document states that the "minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology," suggesting that the previous performance and acceptance criteria of the predicate devices apply.

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

This information is not provided as this document does not describe a clinical study in the context of assessing algorithms or AI performance. The evaluation is based on technological characteristics and comparison to predicate devices, not on a test set of data.

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)

This information is not applicable/provided. There is no "ground truth" establishment in the context of expert review for a test set as described for an AI/ML device. The evaluation is a regulatory review for substantial equivalence.

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

This information is not applicable/provided.

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/provided. This is a physical medical device, not an AI/ML diagnostic or assistive device.

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

This information is not applicable/provided.

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

This information is not applicable/provided. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no training set mentioned, as this is not an AI/ML device.

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

This information is not applicable/provided.

Summary of Device Information Found in the Document (relevant to the 510(k) process):

• Device Name: Scalloped Endopore® Endosseous Dental Implant System
• Intended Use: For use in the upper or lower jaw arches to provide support for a dental prosthesis.
• Predicate Devices: Endopore® Endosseous Dental Implant System (K926354, K971196, K032140).
• Summary Basis for Substantial Equivalence: "The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates."
• Technological Characteristics of Modified Device:
  • Identical to predicates except for:
    • Addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region.
    • A scalloped coronal margin.
  • Dimensions: 10.5 mm in length x 4.8 mm diameter (within range of previously cleared Endopore implants).
  • Principles of operation are identical to previously cleared Endopore Implant System except for attachment of abutments via an internal connection.

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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.

The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.

The provided text describes a 510(k) summary for the Innova LifeSciences Corporation Endopore® Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria or detailing a clinical study with performance metrics in the way a diagnostic algorithm or AI device submission would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of device submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is for a medical device (dental implant), not a diagnostic algorithm or AI device that would typically involve a "test set" in the computational sense. The "performance data" mentioned likely refers to mechanical testing or a summary of existing clinical data related to the predicate devices or the modified device. The document does not specify human subject data for this particular submission's performance evaluation.

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

• Not Applicable. See explanation above.

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

• Not Applicable. See explanation above.

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 hardware medical device; it does not involve AI or human readers in an MRMC study context.

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

• Not Applicable. This is a hardware medical device; it does not involve algorithms.

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

• The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate dental implants through their long-standing use and prior FDA clearances, supported by material characterization and mechanical testing to demonstrate that the new, shorter length of the implant does not compromise these established performance parameters. The "performance data" mentioned would likely consist of engineering and bench test results.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device and does not use a "training set" in the machine learning sense.

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

• Not Applicable. See explanation above.

Ask a specific question about this device

Ask a specific question about this device