(22 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.