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Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time.

Neodent Instruments Kits are intended for sterilization of non-porous loads.

The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g

Neodent GM EasyGuide Kit Cases should not be stacked during sterilization

Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants:

Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry-time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time.

Neodent Instruments Kits are intended for sterilization of non-porous loads.

The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g.

Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices includes grommets manufactured from medical grade silicone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

Here's a summary of the acceptance criteria and study information for the Neodent EasyGuide Kit Cases, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size for each test. For the cleaning validation, it refers to "tests" and "All the acceptance criteria were met," implying multiple runs. For sterilization validation, it mentions "All Biological Indicators," suggesting multiple BIs were used per cycle. For life cycle testing, it states "All evaluated cassettes," suggesting multiple devices were tested. For cytotoxicity, "L929 cell culture" refers to a cell line, not human subjects.
• Data Provenance: The document generally indicates that the testing was performed by JJGC Indústria e Comércio de Materiais Dentários S.A. (Neodent). The country of origin for the data is implied to be Brazil, where the sponsor is located. The studies are non-clinical performance data, likely prospective in nature as they describe validation processes for the device.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The studies described are technical performance validations (cleaning, sterilization, life cycle, biocompatibility), which rely on objective measurements and established scientific standards rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on objective device performance rather than interpretations that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an instrument kit case for sterilization, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance (Algorithm Only)

This information is not applicable. The device is a physical medical device (sterilization kit case), not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Objective Measurements/Standards: For cleaning validation (hemoglobin, protein levels), sterilization (Sterility Assurance Level - SAL, dryness), life cycle (functional integrity after cycles), and biocompatibility (cell proliferation).
• Established Industry Standards: The tests were performed according to recognized standards like AAMI TIR30:2011, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff," and ANSI/AAMI/ISO 10993-5 (Cytotoxicity).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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