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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

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.

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