Search Results

MIS Dental Implant Systems are 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 proposed devices consist of dental abutments and represent a line extension to the MIS CONNECT Conical Connection System.

The proposed MIS CONNECT Conical Connection Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations in the upper or lower jaw and used in conjunction with MIS conical connection implants, MIS V3 and MIS C1 (K163349 and K112162, respectively).

The abutment is placed above the bone level and within the gingival tissue, and is designed to be fitted with a variety of complementary abutment superstructures, including caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject abutments.

Once connected to the implant, the MIS CONNECT Conical Connection Abutment is not intended to be removed.

The abutments are provided in 4.0 and 5.7 mm platform diameters, with an angulation of up to 20°, and at gingival heights of 1.5, 2.0, 3.0, and 4.0 mm.

The proposed MIS CONNECT Conical Connection Superstructures are mounted over the proposed and predicate MIS CONNECT Conical Connection Abutment (Ø4 mm or Ø5.7 mm) and intended for use as an aid in prosthetic dental restoration. The proposed superstructures consist of healing caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject superstructures.

The provided text describes a 510(k) premarket notification for a dental device, the "MIS CONNECT Conical Connection System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness or establishing performance criteria based on an AI model or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study components related to AI/ML medical devices (such as MRMC studies, ground truth establishment for a test set, etc.) are not applicable to this submission.

The "device" in this context is a physical dental implant component (abutments and superstructures), not a software or AI/ML-driven diagnostic tool. The "acceptance criteria" here refer to demonstrating that the new device is as safe and effective as the predicate device.

Here's an analysis of the "acceptance criteria" and "study" as implied by a 510(k) submission for a physical medical device, addressing the relevant points from your request:

Device Name: MIS CONNECT Conical Connection System (dental abutments and superstructures)

Nature of Device: Physical dental implant components, not an AI/ML-driven diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a physical device like this, "acceptance criteria" typically relate to demonstrating the new device performs equivalently to the predicate devices through non-clinical testing (e.g., mechanical testing, biocompatibility, sterilization). There are no "performance metrics" in the sense of accuracy, sensitivity, or specificity as would be for a diagnostic AI.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. For physical device performance testing (fatigue, sterilization), samples would refer to the number of physical devices or batches tested, not patient data. The document mentions "worst case representative samples."
• Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). The data submitted for this 510(k) are from non-clinical laboratory testing (e.g., mechanical fatigue testing, sterilization validation).

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

• Not Applicable. This is not a study assessing diagnostic accuracy or clinical decision-making based on expert consensus. The "ground truth" for mechanical performance is established by engineering standards (e.g., ISO 14801 for fatigue) and laboratory measurements.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" of patient cases requiring adjudication as in a diagnostic accuracy or clinical trial setting.

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

• No. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially those involving human readers and AI assistance). This 510(k) is for a physical dental implant component, not a diagnostic tool, and involves no human readers or AI assistance in its function.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• For Fatigue Testing: Ground truth is defined by the ISO 14801:2016 standard specifications for dynamic fatigue of endosseous dental implants. The "truth" is whether the device withstands specified forces for a specified number of cycles.
• For Biocompatibility: Ground truth is established by ISO 10993-1, and the "truth" is that the materials and manufacturing processes are identical to a previously cleared device.
• For Sterilization: Ground truth is defined by ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat) standards, ensuring a specific sterility assurance level.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device requiring machine learning training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable.

Summary of Study Proving Substantial Equivalence:

The study proving the device meets the acceptance criteria is a collection of non-clinical performance tests and comparisons to predicate devices, rather than a clinical trial or a study assessing diagnostic accuracy. The key components of the "study" are:

• Fatigue Testing: Performed on "worst case representative samples" of the proposed abutments and superstructures according to ISO 14801:2016. The results demonstrated comparable performance to ensure the new dimensions/designs maintain mechanical integrity.
• Biocompatibility Assessment: No new testing was conducted. Substantial equivalence was demonstrated by asserting that the proposed device uses "identical materials" and is "manufactured in the identical manufacturing facility and under the identical manufacturing processes" as the primary predicate device (K173326), and that the intended use and patient contact are identical. This relies on the prior biocompatibility clearance of the predicate.
• Sterilization Validation: For both sterile and non-sterile configurations (for end-user sterilization), validation was conducted on "worst-case construct" samples following ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat), respectively, to achieve a SAL of 10^-6.
• Packaging and Shelf Life: Assessed by demonstrating identity to the predicate device's packaging and material, therefore relying on the predicate's established shelf-life data.

Key Conclusion from the Submission:

"The comparison of the indications for use, technological characteristics, with the inclusion of the results of non-clinical testing, support a conclusion of substantial equivalence of the proposed MIS CONNECT Conical Connection Abutments and Superstructures to the predicate devices." (Page 13)

Ask a specific question about this device