Search Results

MIS V3 Conical Connection Dental Implant System 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants. The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone. The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm; 3. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants surface is sand blasted and acid etched. The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows: "Narrow Platform" (NP) – 3.3mm diameter: blue; "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple. The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch). Components: The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

The provided text describes a 510(k) premarket notification for a dental implant system (MIS V3 Conical Connection Dental Implant System) and focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria based on a clinical study of its performance. The document primarily details mechanical and material equivalency, as well as biocompatibility and sterilization, as opposed to performance metrics that would typically arise from an AI/ML-based medical device.

Therefore, many of the requested items (acceptance criteria table, sample size for test set, expert involvement, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it pertains to a physical dental implant, not an AI/ML device requiring such performance studies.

However, I can extract and present the acceptance criteria for mechanical performance and the study that proves the device meets those from the document, as it is a physical device and not an AI/ML algorithm.

Here's the information that can be extracted relevant to the device's mechanical and material acceptance:

Acceptance Criteria and Device Performance for MIS V3 Conical Connection Dental Implant System

The "acceptance criteria" for this dental implant system are implicitly defined by proving its substantial equivalence to legally marketed predicate devices, particularly regarding mechanical performance and material properties. The primary study proving this is Fatigue Testing per ISO 14801:2007, which is a standard for dental implants.

1. Table of Acceptance Criteria (Implicit from Predicate Equivalence) and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (for Fatigue Testing): The specific number of implants/abutments used in the fatigue test is not explicitly stated as a "sample size" in the document, but it's implied that sufficient samples were tested to demonstrate compliance with ISO 14801:2007.
• Data Provenance: The tests were conducted internally by MIS Implants Technologies Ltd. and by an "independent testing laboratory" for shelf-life testing. The country of origin for the data is not explicitly stated beyond Israel (MIS Implants Technologies Ltd. is based in Israel) for the company and general international standards for the testing. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• N/A. This information is relevant for studies involving human interpretation or clinical outcomes for AI/ML devices. For a physical device demonstrating mechanical and material properties, "ground truth" is established by adherence to recognized international standards (e.g., ISO for mechanical testing, AAMI/ISO for sterilization), and expert judgment is inherent in the development and validation of these standards, not typically in individual "readers" of test results.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods (like 2+1, 3+1) are primarily used in clinical studies or expert review processes for AI/ML performance evaluation. For mechanical and sterilization testing, the "adjudication" is the pass/fail result based on the quantitative measurements against the standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is specific to evaluating the clinical effectiveness of a diagnostic tool (often imagery-based) with and without AI assistance, involving multiple human readers. This document is for a physical dental implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This question applies to AI/ML algorithms. The performance assessment here is for the physical device itself (mechanical, material properties).

7. The Type of Ground Truth Used:

• For mechanical and physical properties (fatigue, material composition, sterility, shelf-life), the "ground truth" is adherence to established international standards and engineering specifications (e.g., ISO 14801:2007, ASTM F136-13, ANSI/AAMI/ISO 11137-1:06, EN ISO 11137-2:12, ISO 17665-1:2006, ISO 14971). Pathological or outcomes data (clinical ground truth) was not required for this 510(k) as per section 9.

8. The Sample Size for the Training Set:

• N/A. This term is relevant for AI/ML models. This is a physical device.

9. How the Ground Truth for the Training Set was Established:

• N/A. This term is relevant for AI/ML models.

Ask a specific question about this device