(162 days)
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The system offers the following components. - Comfort Cap
This document describes a 510(k) premarket notification for the "Advanced Intermezzo Implant System," an endosseous dental implant. The purpose of the 510(k) summary is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for a typical performance study of a diagnostic device. Instead, the focus is on demonstrating "substantial equivalence" to predicate devices through various tests.
The primary method for demonstrating substantial equivalence related to performance was a comparative fatigue test.
While specific numerical acceptance criteria (e.g., minimum force for fatigue failure) are not provided, the reported device performance is that the subject device met the performance of the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence via Fatigue Test) | Reported Device Performance (Summary) |
|---|---|
| To demonstrate "substantial equivalence" in fatigue performance compared to the predicate device per ISO 14801. | The test result of the fatigue test supported that the subject device is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fatigue Testing: The document does not specify the exact sample size used for the comparative fatigue test per ISO 14801. It only states that the test was "conducted on the subject device and primary predicate."
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the test data. However, the submitting company, MegaGen Implant Co., Ltd., is located in the Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this submission is for a medical device (dental implant) and its physical properties (e.g., fatigue strength), not for an AI/diagnostic software where expert ground truth would be established. The "ground truth" here is the physical performance of the device under mechanical stress.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical image interpretation or diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for the physical performance of a dental implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through physical testing and engineering standards. Specifically, comparative fatigue testing per ISO 14801 was used. This standard defines methods for dynamic fatigue testing of endosseous dental implants.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.