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MIS dental implants 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 a patient's chewing 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.

MIS short implants are to be used only with straight abutments.

The MIS short implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.

The MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows:
Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm

The implants surface is sand blasted and acid etched.
The MIS short implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The MIS short implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

This 510(k) summary describes a submission for MIS Short Implants. The document establishes substantial equivalence to predicate devices through a comparison of technological characteristics and performance. No specific acceptance criteria or a dedicated study proving performance against them are explicitly detailed in the provided text. Instead, the focus is on demonstrating equivalence based on existing data and non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a specific study designed to meet them. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly tied to the safety and effectiveness demonstrated by the predicate devices and confirmed through non-clinical testing and literature review for the new device.

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

• Sample Size for Test Set:
  • Non-clinical/Fatigue Test: Not explicitly stated. The document mentions "Fatigue test was performed on MIS short implants and its results were found satisfying." The number of implants tested is not provided.
  • Clinical Evaluation: "case studies with 30 months follow up" – the number of cases/patients is not explicitly stated. The phrasing "case studies" suggests an unspecified number of individual cases rather than a large cohort.
• Data Provenance:
  • The fatigue tests were performed by the manufacturer, MIS Implants Technologies Ltd. (Israel).
  • The clinical evaluation was "based on literature review and case studies," suggesting a mix of published research and internal data. The geographic origin of the literature or specific case studies is not specified beyond the company being located in Israel. The statement that "MIS short implants are manufactured to the same Titanium alloy" as the predicate devices implies reliance on the established performance of those devices.

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

Not applicable. The document does not describe a process of establishing ground truth by experts for a specific test set. The clinical evaluation references "literature review and case studies," which would rely on diagnoses and outcomes made by clinicians in those cases, but no specific expert panel or their qualifications for establishing ground truth are mentioned.

4. Adjudication Method for the Test Set

Not applicable. No explicit adjudication method is described for defining a ground truth or reconciling discrepancies, as there isn't a dedicated "test set" in the sense of a dataset requiring expert labeling for a performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a dental implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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 (dental implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the assessment of the MIS Short Implants relies on:

• Biocompatibility/Material Standards: Compliance with ASTM F 136-08 for the titanium alloy.
• Mechanical Performance: Results of fatigue testing.
• Clinical Outcomes/Experience: "Literature review and case studies with 30 months follow up" to assess safety and effectiveness. This would implicitly rely on clinical diagnoses, radiographic evaluations, and patient-reported outcomes to determine the success or failure of the implants.
• Substantial Equivalence: The primary "ground truth" or benchmark is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a physical device, not a machine learning algorithm.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the MIS Crest Widener, addressing your requested information:

Summary of Acceptance Criteria and Device Performance (based on the provided document):

The provided 510(k) summary for the MIS Crest Widener does not contain specific quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., success rates, bone growth measurement).

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" being evaluated and asserted is primarily in terms of:

• Intended Use: The device shares the same intended use as its predicate devices: "Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation."
• Technological Characteristics: The device is made of similar materials (Titanium alloy complying with ASTM F136-02), has a similar mechanism of action (distraction osteogenesis via screw activation), and a similar duration of placement.

Therefore, the "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device performs as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness.

Key Missing Information:

It's crucial to note that the provided 510(k) summary does not include any clinical study data or performance metrics that would typically be found in a study proving a device meets specific acceptance criteria. This type of submission relies on the established safety and effectiveness of the predicate devices.

Given this, I cannot fill in precise quantitative values for acceptance criteria or device performance as they are not present in the document.

Detailed Breakdown of Your Requested Information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document does not describe a clinical study with a "test set" of patients or data to evaluate the device's performance. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo clinical performance data.
• Data Provenance: Not applicable, as no dedicated test set data is presented.

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

• Not applicable. As there is no clinical test set described, there is no mention of experts establishing ground truth for such a set. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices, as deemed by prior FDA clearances.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set or data analysis requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a manual surgical instrument and does not involve any algorithms or standalone software performance.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the documented performance, safety profile, and regulatory history of the legally marketed predicate devices. The new device asserts equivalence to these established devices. This is not "expert consensus," "pathology," or "outcomes data" specifically generated for the MIS Crest Widener, but rather the established understanding of the predicates.

8. The Sample Size for the Training Set

• Not applicable. This device is a manual surgical instrument and does not involve machine learning algorithms that require a "training set" of data.

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

• Not applicable, as there is no training set for this type of device.

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The MIS Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document describes a 510(k) summary for the "MIS Dental Implant System," which is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

The information primarily focuses on:

• Device Description: Components of the MIS Dental Implant System (implants, cover screws, healing caps, abutments, surgical instruments).
• Materials: Implants are made from medical grade 4 (GD-4) pure titanium (ASTM F67-95).
• Intended Use: Surgical and restorative applications in the upper or lower jaw to support prosthetic devices and restore chewing function.
• Predicate Devices: Comparison to 3i Dental Implant System and ITI Dental Implant System.
• Substantial Equivalence Claim: The device has the same intended use and equivalent performance characteristics to the predicate devices.
• FDA Clearance Letter: Confirmation of substantial equivalence by the FDA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text. The document is a regulatory submission, not a scientific study report.

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