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ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla.

ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are:

3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible

5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and

4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla.

The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.

The technological characteristics of the modified Endopore® Anatomic Endosseous Dental Implant System also are identical to those of the predicates, except for the use of customized configurations to fit specific anatomic jaw locations, including the anterior mandible, anterior maxilla, posterior mandible and posterior maxilla, and the addition of concentric "steps" along the length of the implant's body. The dimensions of the Anatomic Implant System include diameters of 3.75 mm, 4.5 mm, and 5 mm and lengths of 8.5 mm, 10 mm, 12 mm, and 15 mm. These dimensions are within the range of those of the previously cleared Endopore® Endosseous Dental Implant System, with the addition of the 3.75 mm diameter and 15 mm length.

The provided text is a 510(k) summary for the Endopore® Anatomic Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the typical sense of a clinical or analytical performance study.

Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, standalone performance) are not applicable or not available in this type of regulatory submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

For 510(k) submissions, the primary "acceptance criterion" is proving substantial equivalence to a legally marketed predicate device. Device performance is typically evaluated by demonstrating that the new device shares similar technological characteristics, intended use, and performs no worse than its predicate.

Explanation: This 510(k) summary explicitly states: "The minor modification to the design of the Scalloped Endopore® Endosseous Dental Implant System and Endopore® Endosseous Dental Implant System does not alter the implant's indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicate devices." This is the core "study" and "acceptance criterion" for a 510(k) – demonstrating that the new device is as safe and effective as a legally marketed one.

Detailed Information on Studies:

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

   • Not applicable/Not provided. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not on a new clinical or analytical performance study with a test set of data.

2. 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/Not provided. No "ground truth" establishment by experts for a test set is mentioned in this substantial equivalence submission.

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

   • Not applicable/Not provided. No adjudication method is mentioned as there's no disclosed test set or expert review process.

4. 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 a dental implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is irrelevant.

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

   • Not applicable. This is a physical medical device (dental implant), not an algorithm or software. "Standalone performance" in this context would refer to material testing and mechanical performance, which are part of device design and manufacturing but not explicitly detailed as "standalone studies" in this summary for substantial equivalence.

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

   • Not applicable. For this type of 510(k) submission, "ground truth" in the sense of a clinical benchmark for a new diagnostic or prognostic algorithm is not relevant. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their known performance/safety profiles.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set.

In summary: The K052951 document is a 510(k) summary demonstrating substantial equivalence for a dental implant system. It explicitly states that the device's design modifications do not alter its fundamental scientific technology or intended use, thereby making it substantially equivalent to predicate devices. This type of submission relies on comparative analysis of specifications and intended use rather than new clinical or performance studies with separate test and training sets.

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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 Pitt-Easy™ Dental Implant System

The provided document is a 510(k) summary for a dental implant system. It details the device's name, submitter, date prepared, predicate devices, intended use, principles of operation, and technological characteristics. The document explicitly states that the "minor modifications to the design of the Entegra™ Dental Implant System (K961385) and Bicortical® Screw Dental Implant System (K983120) do not alter the implant's fundamental scientific technology" and that the "modified device is substantially equivalent to the predicate devices."

Therefore, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a declaration of substantial equivalence based on design and technological characteristics being identical or having minor modifications compared to previously cleared predicate devices, rather than performance data against specific acceptance criteria.

Without any details on acceptance criteria or a performance study in the provided text, I cannot complete your request.

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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.

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