(79 days)
BioHorizons Tapered Internal 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.
The BioHorizons Tapered Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant material is titanium alloy as specified in 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 threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• Lok® microchannels, to the implant collar of select models. 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 with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.
The provided document is a 510(k) premarket notification for a medical device called "BioHorizons Tapered Internal Implants." It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and performance through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of submission. The document primarily focuses on technical characteristics and mechanical testing to justify equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable as this is a substantial equivalence claim, not a de novo clearance with specific acceptance criteria from a clinical trial. The "acceptance criteria" here relate to demonstrating equivalence in design, materials, and mechanical performance to predicate devices. The performance reported is that the device "performs as well as the referenced predicate device."
| Feature/Performance Aspect | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Implant-Abutment Connection) | Must meet or exceed the performance of predicate devices as tested by ISO 14801. | "The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices." |
| Material Composition | Must be ASTM F136 compliant (Ti-6Al-4V ELI Alloy). | "Implant material is titanium alloy as specified in ASTM F136..." |
| Surface Treatment | Must be RBT and/or Laser-Lok microchannels, proven effective in predicate devices. | "Roughening the threaded surface with Resorbable Blast Texture (RBT) media... and by micro-machining grooves, known as Laser-Lok® microchannels..." |
| Sterility Assurance Level | Minimum 10-6 SAL, validated per ANSVAAMI/ISO 11137-1. | "Provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1..." |
| Intended Use | Must align with the intended use of predicate devices. | The intended use for the subject device is virtually identical to that of the BioHorizons Tapered Internal Implant System (K071638). |
| Overall Equivalence | Must be substantially equivalent in design, materials, intended use, and performance to predicate devices. | "The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform as well as the referenced predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for a "test set" in the context of a clinical study. The testing refers to "Mechanical testing of the 3.0mm implant-abutment connection... in conjunction with angled prosthetic abutments representative of the worst-case scenario." This implies an engineering test, not a clinical trial with human subjects. Thus, the "sample size" would refer to the number of devices mechanically tested, which is not detailed but is typically a small number for such engineering tests.
- Data Provenance: The 'data' generated is from mechanical testing conducted according to ISO 14801 and FDA guidance documents. This is laboratory-based engineering data, not clinical data from countries of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on engineering and material standards (ASTM, ISO) and comparison to predicate devices, not on expert consensus for ground truth on clinical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.
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-powered diagnostic tool. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a dental implant, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) is based on:
- Established engineering standards (e.g., ISO 14801 for fatigue testing, ASTM F136 for material).
- Performance of legally marketed predicate devices (K071638 and K093321), which have already demonstrated safety and effectiveness through their own clearance/approval processes.
- Physical and chemical properties of the materials and design features.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the machine learning/AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI algorithm is involved.
In summary: The provided document is an FDA 510(k) clearance letter and summary for a dental implant, not a study evaluating acceptance criteria for a diagnostic device or AI software. The "study" referenced is mechanical testing to demonstrate substantial equivalence to existing devices.
§ 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.