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Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.

When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.

The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:

• Temperature: 270°F/132°C
• Exposure time: 4 minutes.
• Drying time: 20 minutes.
• The cassettes are not to be stacked during sterilization.

KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.

Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.

The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.

The provided text describes the "Microdent Sterilization Cassette" and its performance data. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test. It mentions that "KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively." This suggests that at least two representative models were likely tested for some validations.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are referred to as "non-clinical test data" and performed by Implant Microdent System S.L.U. (a Spanish company), implying prospective, bench testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for these non-clinical tests is based on established scientific methodology and quantitative measurements (e.g., SAL ≤ 10⁻⁶, µg/cm² for protein/hemoglobin, visual inspection for moisture/damage), rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable, as the tests are non-clinical and rely on objective measurements against defined standards, not human interpretation that would require adjudication.

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 non-clinical device (sterilization cassette), not an AI-powered diagnostic or assistive tool.

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

The ground truth for these tests is based on:

• Established scientific standards and regulatory guidelines: e.g., ISO 17665-2:2009, ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI ST77:2013 for sterilization; AAMI TIR30:2011 for cleaning.
• Objective measurements and visual inspection: e.g., sterility assurance level, protein/hemoglobin levels, absence of visible moisture or damage.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.

Microdent Genius Implant System is comprised of dental implants and prosthetic components. Microdent Genius dental implants are internal connection endosseous implants machined titanium that can be used with deferred load or immediate load techniques. If sufficient bone depth is available the implant can be inserted sub-crestal. Microdent Genius Implant is recommended to place 2mm sub-crestal position.

The implant has a connection formed by six grooves extending radially around the axis of the implant to provide a precise position of the abutment.

Microdent Genius Implants are provided with blasted surface.

The implants are supplied sterile and the abutments are provided non-sterile.

Implants are also offered in various diameters and length.

Contained various Microdent Genius abutments made of Ti-6AL 4-V-ELI alloy.
The abutments Conical, Angled and Mini Capitel are used for cemented and screw-retained restorations.

A Cover screw protects the inner configuration of the implant and supplied sterile with the implant.
Healing abutment to shape the soft tissue during the healing phase.
The Retention Screws are used for securing the abutments to the implant.

Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.

All abutments include appropriate features and dimensions to mate with Microdent Genius implants.

The provided document is a 510(k) Premarket Notification for the Microdent Genius Implant System, dating back to 2015. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the information provided is primarily a comparison to predicate devices and describes non-clinical testing for compliance with standards, rather than a study designed to meet specific acceptance criteria for performance as would be seen for complex diagnostic or AI devices.

Based on the provided text, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a dental implant system (a medical device, not an AI/diagnostic device), the "acceptance criteria" are compliance with established ISO standards and demonstration of substantial equivalence to a predicate device. The "device performance" is therefore shown through successful completion of these non-clinical tests and the comparison of characteristics.

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test. The document refers to "bench testing" and "analyses" without providing specific numbers of implants or abutments tested for each non-clinical performance test.
   • Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting on manufactured devices, not using patient data. The manufacturer (Implant Microdent Systems) is located in Spain.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices (especially AI/imaging devices) where human experts determine the true condition of a patient based on clinical data. For this dental implant system, the "truth" is determined by compliance with engineering and material standards and performance under simulated conditions.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically employed in studies where human readers are interpreting data, and disagreements need to be resolved. This document details non-clinical laboratory testing.

4. 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:

   • No. This is a dental implant system, not a diagnostic or AI device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a dental implant system, not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is established by engineering standards and material specifications (e.g., ISO standards). Tests were performed according to these standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility), and the device's adherence to these predefined criteria serves as the "truth." There is no clinical "truth" from patients or expert consensus in this non-clinical submission.

7. The sample size for the training set:

   • This information is not applicable. There is no "training set" in the context of a dental implant system's 510(k) submission. This concept is relevant for AI/machine learning models.

8. How the ground truth for the training set was established:

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

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