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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.

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