(426 days)
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fine intended as belients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
The BTI Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant and 4.5 to 5.5 mm for wide platform. Lengths range from 7,0 to 18,0 mm. Narrow platform implants are 3,3 wide in the surgical area, with lengths ranqing from 10,0 to 15,0 mm.
This document is a 510(k) premarket notification for the B.T.I. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics for a specific study proving the device meets those criteria is not available in the provided text.
Here is an attempt to address the requested information based on what is available and to indicate what is missing:
Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The provided 510(k) notification for the B.T.I. Dental Implant System is a premarket submission to the FDA. The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to provide detailed performance data against specific acceptance criteria in the way a clinical trial or device validation study would. Therefore, the document does not contain a typical "acceptance criteria" table with corresponding performance data from a specific study designed to meet those criteria.
Instead, the submission focuses on demonstrating that the B.T.I. Dental Implant System has the same intended use as, and similar technological characteristics to, an existing predicate device (Osseotite Dental Implants manufactured by Implant Innovation Inc, K013570). The FDA's letter confirms substantial equivalence based on the information provided, which would typically include comparisons of materials, design, manufacturing processes, and potentially some bench testing data, but the specifics of such comparisons or any defined acceptance criteria are not detailed in the provided excerpts.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document aims to establish substantial equivalence to a predicate device rather than report against specific performance acceptance criteria. | Not specified in the provided document. No specific performance metrics or data from a study are reported. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified. (The manufacturer, B.T.I. Biotechnology Institute, S.L., is located in Spain).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's 510(k) submission as presented here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Not relevant to the type of information presented in this 510(k) summary.
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:
- No. This is a dental implant system (a physical medical device), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement effect size are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the context of device performance data. For a physical device like a dental implant, "ground truth" often relates to in-vitro testing results (e.g., mechanical strength, material compatibility), animal studies, or clinical outcomes from previous versions or similar devices. However, no such specific "ground truth" establishment details are provided in this summary. The "ground truth" for the 510(k) submission itself is based on the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
- Not applicable / Not specified. This is a physical dental implant device, not a machine learning model that would require a 'training set'.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As above, this is not relevant for a physical medical device.
Summary of available information:
The provided document is a 510(k) summary focused on establishing substantial equivalence for the B.T.I. Dental Implant System to a predicate device (Osseotite Dental Implants, K013570). It defines the device, its intended use, and the predicate. The FDA's review confirms this substantial equivalence. However, it does not include detailed device-specific acceptance criteria or a study report demonstrating the device's performance against such criteria. The FDA letter is confirmation of regulatory clearance, not a performance 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.