Search Results

BioHorizons Single-stage Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

BioHorizons Single-stage Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

BioHorizons Single-stage Implants are machined titanium, screw-form endosseous implants supplied in 3.5mm, 4.0mm, 5.0mm, 6.0mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant material is titanium alloy as specified ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance to ANSI / AAMI / ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The BioHorizons Single-stage Implant System includes a series of implant catalog item numbers with Laser-Lok® technology applied to the implant collar to provide additional treatment options for the dental implant clinician.

The provided document is a 510(k) Premarket Notification for the BioHorizons Single-stage Implant System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for a novel drug or a high-risk medical device.

Therefore, the document does not contain the specific information requested regarding acceptance criteria, a standalone study to prove meeting acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Metrics: For a 510(k) submission, the primary goal is to show that the new device (BioHorizons Single-stage Implant System in this case) is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (materials, design, intended use, sterilization methods) and citing existing regulatory approvals for the predicate device, rather than setting and meeting new performance acceptance criteria through a specific study in the way a drug or novel biologic might.

• No Dedicated "Study" in the Requested Format: The document doesn't describe a stand-alone prospective or retrospective study designed to test the device against specific performance acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate devices.

Let's address the specific points based on what can be inferred or what is explicitly stated in the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent points (2-9) are largely not applicable in the context of this 510(k) submission, as it isn't a clinical trial demonstrating performance against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No dedicated "test set" or clinical study with a specific sample size is mentioned. The submission relies on the established performance of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set was established as part of this submission framework.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or expert adjudication process is described here.

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, not an AI-assisted diagnostic tool.

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 in the context of a new performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and clinical use.

8. The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an algorithm being developed.

9. How the ground truth for the training set was established: Not applicable. Same as above.

Ask a specific question about this device

The BioHorizons Single-stage endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

The BioHorizons Single-stage dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 7mm, 9mm, 10.5mm 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM Fi 185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a 11/10T - n sterility assurance level of 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

The provided text is a 510(k) summary for the BioHorizons Single-stage Implant. It is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices. This type of submission typically focuses on demonstrating equivalence in design, materials, and intended use, rather than presenting a detailed study with acceptance criteria and performance metrics as would be found in a clinical trial or a performance study for AI/software devices.

Therefore, based on the provided text, I cannot extract information related to:

• A table of acceptance criteria and reported device performance.
• Sample size for a test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states:

• "The fundamental scientific technology of the device is identical to the referenced predicate devices."
• "All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Single-stage endosseous implants."
• "The BioHorizons Single-stage implants are substantially equivalent to all features of the predicate Maestro System and Prodigy System device which could affect safety or effectiveness because of the similarities in design, material and intended use."

This indicates that the "study" demonstrating the device meets "acceptance criteria" (which are implicit in the predicate device's prior clearance) is the demonstration of substantial equivalence to previously cleared devices (Maestro System, K020645, and Prodigy System, K042429). The acceptance criteria for a 510(k) submission are generally that the new device does not raise new questions of safety and effectiveness compared to the predicate.

In summary, this document does not contain the detailed study information as requested by the prompt because it is a 510(k) summary relying on substantial equivalence, not a de novo clinical or performance study report.

Ask a specific question about this device