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The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

The BioHorizons Tapered Internal Implant System may be restored immediately

• 1. with a temporary prosthesis that is not in functional occlusion or
• 2. when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Internal Implant System is a system of tapered, threaded, internal connection, root form implants and matching abutments intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The external design of the implant is the same as that of the Bio-Lok Implant System, including the Laser-Lok® collar. The internal connection and the platform are the same as those of the BioHorizons Prodigy System™ Endosseous Implants.

The provided 510(k) summary for the "BioHorizons Tapered Internal Implant System" (K071638) does not describe any specific acceptance criteria for performance or a study demonstrating the device meets such criteria.

Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. This means the device is being presented as being as safe and effective as a legally marketed device, rather than providing novel performance data for specific criteria.

Therefore, most of the requested information cannot be extracted from this document because the regulatory pathway chosen (substantial equivalence) does not typically require the type of detailed performance criteria and study results you are asking for (e.g., sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, etc.).

Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:

Description of Acceptance Criteria and Proving Device Meets Criteria

No specific acceptance criteria for device performance are mentioned in this document. The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices.

No study proving the device meets specific acceptance criteria is described in this document. The document asserts that "BioHorizons Implants Systems, Inc. demonstrated that... the BioHorizons Tapered Internal Implant System is substantially equivalent in indications and design principles to predicate devices." This demonstration would likely involve comparisons of design, materials, and intended use, rather than a clinical performance study with defined criteria and outcomes.

Requested Information:

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

• Acceptance Criteria: Not specified in this document. The "acceptance" is based on substantial equivalence to predicate devices, not on defined performance metrics.
• Reported Device Performance: Not reported in this document. Performance is implicitly assumed to be similar to the predicate devices due to substantial equivalence.

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

• Sample Size: Not applicable/not provided. No specific test set for performance evaluation is described.
• Data Provenance: Not applicable/not provided.

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/not provided. No ground truth establishment for a test set is described.

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

• Not applicable/not provided. No adjudication method for a test set 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 device is a dental implant system, not an AI-powered diagnostic tool, so MRMC studies and AI assistance are irrelevant to this submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable/not provided. Ground truth for performance is not discussed as no performance study is detailed.

8. The sample size for the training set

• Not applicable/not provided. No training set for an algorithm is described.

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

• Not applicable/not provided. No training set or ground truth establishment for it is described.

Summary of Device and Regulatory Context (from the document):

• Device Name: BioHorizons Tapered Internal Implant System
• Intended Use: Artificial root structure for single tooth replacement, fixed bridgework, and dental retention in the mandible or maxilla. Can be immediately restored with a temporary prosthesis (not in functional occlusion) or when splinted/stabilized with an overdenture.
• Device Description: Tapered, threaded, internal connection, root form implants with matching abutments. External design (including Laser-Lok® collar) is like the Bio-Lok Implant System. Internal connection and platform are like the BioHorizons Prodigy System™ Endosseous Implants.
• Classification: Class II (Endosseous dental implant, 21 CFR 872.3640; Endosseous dental implant abutment, 21 CFR 872.3630).
• Regulatory Pathway: 510(k) premarket notification based on substantial equivalence to predicate devices. This means the device is considered "as safe and effective" as devices already legally marketed, rather than requiring novel clinical performance data that would specify acceptance criteria and study results.

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