(99 days)
The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.
Here is an analysis of the provided text regarding the acceptance criteria and study for the IMTEC MDI MII One-Piece Implant:
The document is a 510(k) Premarket Notification for the IMTEC MDI MII 2.9mm One-Piece Implant. As such, the purpose is to demonstrate substantial equivalence to predicate devices, not to establish new performance acceptance criteria through clinical trials. The "acceptance criteria" here refers to the demonstration of safety and effectiveness through equivalence, rather than specific performance metrics validated by a clinical study against a predefined threshold.
Based on the provided text, a formal study with detailed acceptance criteria and reported device performance in the way a clinical trial would typically be structured does not appear to have been conducted for this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (as presented for equivalence) |
|---|---|---|
| Intended Use | The MDI MII intended use and indications for use were previously cleared by the FDA for the various predicate devices listed. (Matches that of predicate devices). | Supports single or multi-unit restorations, immediate loading when good primary stability is achieved, stability and long-term fixation of dentures. |
| Technical Characteristics | Similar to those of the predicate devices. Design similarities between the proposed MDI MII implant and currently marketed fixtures within the IMTEC MDI Dental Implant System. Equivalent in terms of size, materials of construction, performance characteristics, and basic design. | Composed of Titanium alloy; thread lengths 10mm, 13mm, 15mm, 18 mm; blasted & etched surface; micro-threads at intra-osseous collar; transgingival collar 2mm; two prosthetic head design options (O-ball and Tapered Abutment); O-ball head identical to IMTEC MDI implant; abutment portion coated with Titanium Nitride. Auto advancing cutting threads (similar to IMTEC Endure Implant system) |
| Safety and Performance | The addition of auto advancing, cutting threads have no adverse affects on the performance or safety of the IMTEC MDI MII 2.9mm Implant as evaluated in the performance testing conducted by the University of Georgia. | No adverse effects reported from the testing. The same types of safety and effectiveness characteristics are inherent with each of the devices (referring to predicate devices). Does not raise new questions related to safety or efficacy. |
Important Note: The "acceptance criteria" here is fundamentally about demonstrating that the new device is as safe and effective as a legally marketed predicate device, not about meeting specific numerical performance targets established through a de novo clinical study.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text for "performance testing." The text mentions "performance testing conducted by the University of Georgia" and "Laboratory testing by the Medical College of Georgia," but no details on the sample size (number of implants tested, number of tests performed) are given.
- Data Provenance:
- Country of Origin: USA (University of Georgia, Medical College of Georgia).
- Retrospective or Prospective: Unspecified. However, for laboratory performance testing in a 510(k) submission, it would generally be prospective testing of the device prototypes/samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through comparison to predicate devices, adherence to recognized standards (implied by the "performance testing"), and the scientific principles behind dental implant design and materials, rather than expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is typically used in clinical trials or studies where human readers/evaluators are assessing outcomes or images against a "ground truth" established by multiple experts. The document describes laboratory performance testing and comparison to predicates, not a reader study.
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 is a 510(k) for a physical dental implant, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices. The new device is considered safe and effective if it can demonstrate substantial equivalence to these predicates through comparison of:
- Intended use
- Technological characteristics (including materials, design, size, etc.)
- Performance (demonstrated through laboratory testing where similarities are not direct)
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a 510(k) for a physical device like this. Training sets are typically used for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.