(141 days)
OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
Implant Innovation's dental implant systems include screw-form (i.e. threaded) titanium implants with a machined, external HEX to assist in placement and to provide antirotation features for the restoration. The OSSEOTTE® Brand implants have a special dual acid-etched treatment process to increase surface roughness.
The OSSEOTITE NTTM Dental Implants are tapered implants designed to mimic the shape and form of a natural tooth. The taper aspect ratio varies depending upon the length and diameter. The NT implants will be available in diameters of 3.25, 4.0, 5.0 and 6.0 mm and lengths of 8.5, 10.0, 11.5, 13.0 and 15.0 mm.
The provided document, K014235 for OSSEOTITE NT™ Implants and Accessories, is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through clinical trials with specific acceptance criteria, as might be seen with a PMA (Premarket Approval) application.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a training set.
However, I can extract the information that is present concerning performance data and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Mechanical strength at least equivalent to currently marketed OSSEOTITE® Dental Implants (predicate device). | "mechanical testing of the implants demonstrated that the OSSEOTITE NTTM Dental Implants possess mechanical strength at least equivalent to the currently marketed OSSEOTITE® Dental Implants." |
2. Sample Size Used for the Test Set and Data Provenance:
- The document mentions "mechanical testing of the implants." This implies in vitro testing.
- Sample Size: Not specified.
- Data Provenance: In vitro testing (laboratory-based), not specified geographical origin. This is not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This device is not an AI/imaging device where human reader performance would be assessed.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:
- Not applicable. This device is an implant, not an algorithm.
7. The Type of Ground Truth Used:
- For the mechanical performance, the "ground truth" would be the measured mechanical properties (e.g., strength, fatigue resistance) of the predicate device, against which the new device was compared. This is a scientific measurement, not an expert-derived ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is a physical medical device, not an AI model.
In summary, this 510(k) filing relies on demonstrating substantial equivalence primarily through comparison of physical characteristics and mechanical testing to existing predicate devices, rather than clinical efficacy studies with specific acceptance criteria or expert-based ground truth evaluations.
§ 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.