(79 days)
BioHorizons Tapered Internal Plus 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. The implants 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 Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications.
The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, to the implant collar. 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°, validated in compliance with 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 provided text describes a 510(k) summary for the BioHorizons Tapered Internal Plus Implants. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, independent device performance.
Therefore, many of the requested categories related to clinical study design, AI performance, expert review, and ground truth are not applicable to this type of regulatory submission. The document relies on mechanical testing to show equivalence, not clinical effectiveness studies as might be found for more complex medical devices, especially those involving AI/ML.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from equivalence claim) | Reported Device Performance (from "Summary of Testing") |
|---|---|
| Substantial equivalence to predicate device in terms of performance, safety, and effectiveness. | Fatigue Load Testing: Results demonstrate substantial equivalence to predicate devices (in conjunction with both straight and angled prosthetic abutments). |
| Insertion Torque Testing: 3.0mm implant level driver can fully seat 3.8mm Tapered Internal Plus implants in all bone densities without loss of function of implant hex or driver hex. Average insertion torque: 214.4 Ncm. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test (fatigue or insertion torque). Mechanical testing typically uses a small, statistically relevant number of samples for each size/configuration.
- Data Provenance: The document implies the testing was performed internally by BioHorizons or a contracted lab, as it refers to "the subject devices" and "this submission." No specific country of origin is mentioned beyond the manufacturer's location (Birmingham, AL, USA). The data is generated as part of a regulatory submission, which is prospective in the sense of demonstrating performance for a new product, but not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a mechanical engineering study, not a clinical study involving human assessment or interpretation where experts would establish ground truth for a test set in the conventional sense (e.g., radiologists for imagery). The "ground truth" here is the physical performance of the device against established engineering standards (ISO 14801).
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. This is not a study where human adjudication of results/diagnoses would be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is not a study involving human readers or comparative effectiveness in a clinical setting. It's a mechanical testing report for hardware.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical dental implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical Performance Against Standards: The ground truth for this submission is the objective measurement of mechanical properties (fatigue strength, insertion torque) as compared to:
- The performance of the predicate device.
- Established industry standards like ISO 14801.
- Guidance documents such as the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.