(95 days)
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.
ITI implants have an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasma-sprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths.
This document is a 510(k) Summary for the ITI® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific acceptance criteria or device performance data for this product.
Therefore, I cannot fully answer your request based on the provided text. The document states:
"The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle."
This indicates that the submission is for a device that is essentially the same as a previously cleared one, and as such, detailed performance studies with acceptance criteria are typically not required. The basis for substantial equivalence is the identity of the device to its predicate.
However, I can extract information related to the device and its regulatory context:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document does not describe acceptance criteria or reported device performance for a new study. Instead, it asserts that the device is identical to previously cleared devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or data provenance is mentioned as no new performance study was conducted.
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. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 document pertains to dental implants, not AI-assisted reading or diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document pertains to dental implants, not algorithms.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new ground truth was established as no new performance study was described.
8. The sample size for the training set
- Not applicable. No training set for a new study is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment is described.
Summary of what the document does indicate:
- Device Name: ITI® Dental Implant System
- Indications for Use: Surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients, for single-stage or two-stage surgical procedures.
- Predicate Devices: ITI Dental Implant System and Implant Innovations Inc. Osseotite Dental Implants (K013570).
- Basis for Substantial Equivalence: The device is identical in intended use, material, surface treatment, design, and operating principle to previously cleared ITI implants. The contraindication regarding tobacco use has also been removed, aligning with the predicate Implant Innovations Inc. Osseotite Dental Implants.
- Device Components: Grade 4 titanium (cold worked), grit blasted and acid-etched (SLA surface) or titanium plasma-sprayed (TPS surface) anchorage surface, smooth machined neck. Available in diameters from 3.3 to 4.8 mm and various lengths.
- Regulatory Classification: Class III, Product Code DZE, Regulation Number 21 CFR 872.3640 (Endosseous Implants).
§ 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.