(79 days)
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically placed in bone of the upper or lower jaw arches to provide support for dental prosthesis. The Pitt-Easy Implant consists of two component parts: the implant (root component) and a threaded healing cap. In addition, attachments that are screw-retained, such as restorative abutments, are available for attachment to the root component.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K053242) | Device found Substantially Equivalent. |
| No change in composition, design, or intended use compared to predicate. | No change in composition, design, or intended use reported. Only a new contraindication was added. |
| Complies with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | FDA states the device is subject to general controls provisions and must comply with all Act's requirements. |
| Inclusion of new contraindication for Pitt-Easy 3.25mm diameter implants (not suitable for single tooth replacement in the posterior region). | The new contraindication was proposed and accepted as a change to the Directions for Use (DFU). |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a specific "test set" or its sample size. This document describes a 510(k) submission, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to justify efficacy or safety. The submission is based on the assertion that the device is essentially unchanged from its predicate, with only an added contraindication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. As noted above, this document does not refer to a study involving a "test set" and ground truth establishment in the traditional sense of a clinical trial for performance evaluation.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set or an adjudication process within this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document makes no mention of an MRMC comparative effectiveness study or any study comparing human reader performance with and without AI assistance. This device is a physical dental implant, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This is not an algorithmic device.
7. The Type of Ground Truth Used:
Not applicable. The approval process for this device is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy against a "ground truth" through a clinical study. The "truth" in this context is that the device, with the specified contraindication, is considered as safe and effective as the predicate.
8. The Sample Size for the Training Set:
Not applicable. This document pertains to a physical dental implant device and not a machine learning algorithm, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.