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Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the 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, 30-minute dry time (for GM Zygomatic Surgical Kit Case) or 20-minute dry time (for GM Helix LG Compact Surgical Kit Case)

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time (only for GM Helix LG Compact Surgical Kit Case)

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Zygomatic Surgical Kit Case and the instruments is 738.1 g. The weight of the empty kit case is 515 g.

The combined weight of the GM Helix LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g.

Neodent Instrument Kit Cases should not to 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 devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.

The medical device in question is the Neodent Instrument Kit Cases, intended for use in sterilizing other medical devices by healthcare providers using moist heat (steam). The provided documentation details the acceptance criteria and the studies conducted to demonstrate its performance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

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

Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time (or 40 minutes for model number 110.296)

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

The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 devices include six (6) such kits. The lids are manufactured from injection molded polyphenylsulfone resin, the tray base and case bottoms are manufactured from injection molded polysulfone resin. The designs include grommets of various geometries manufactured from molded silicone that retain the instruments within the tray. Certain designs also incorporate a holder of a single geometry made of Ti-6Al-4V-ELI to position items in the trays. The subject device kits are provided nonsterile to the end- user.

The provided text does not contain information about an AI/algorithm-based device. Instead, it describes a traditional medical device submission for "Neodent Instrument Kits," which are sterilization trays. As such, the concept of a "test set," "training set," "ground truth," "MRMC comparative effectiveness study," or "AI assistance" is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K171713) for a Class II medical device (Sterilization Wrap) under product code KCT.

However, I can extract information related to the performance testing and acceptance criteria for this physical medical device, which is how it meets its intended use.

Here's an interpretation of the document's content relevant to acceptance criteria and performance:

The "Neodent Instrument Kits" are reusable rigid containers intended to enclose other medical devices for sterilization by a healthcare provider. The kits themselves must allow sterilization of the enclosed medical devices and maintain their sterility with an FDA-cleared wrap.

The study proves that the device meets acceptance criteria through a series of non-clinical performance tests, demonstrating its suitability for its intended use and substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the "Purpose of the Testing" and the "Results" sections. The "Conclusion" explicitly states that the device "performs as well as or better than the legally marketed device K171713."

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

The document does not explicitly state the "sample size" in terms of number of devices tested for each non-clinical performance pathway. This type of information is typically found in the full test reports, not a 510(k) summary. However, it implicitly refers to "the device" (singular, representing the device line) being tested.

• Test Set/Sample Size: Not explicitly stated as a numerical count of individual devices tested, but the results refer to the performance of "the device" and "the subject devices." For physical device testing, a representative sample is used, but the exact number isn't in this summary.
• Data Provenance: The study was conducted by JJGC Indústria e Comércio de Materiais Dentários S.A. (manufacturer and sponsor) located in Curitiba, Parana, Brazil. The data would be considered retrospective in the context of the 510(k) submission, as it describes tests already performed to support the marketing application.

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

This question is not applicable as the device is a physical sterilization tray, not an AI/algorithm-based device requiring expert interpretation of diagnostic images or similar data. The "ground truth" (e.g., sterility, cleanliness, material biocompatibility) is established through standardized laboratory testing methods, not expert consensus in an observational study.

4. Adjudication Method for the Test Set

Not applicable. As a physical device undergoing laboratory performance testing, "adjudication" in the sense of reconciling expert opinions on complex data (common in AI studies) is not relevant. Test results are typically objective measurements or qualitative observations (e.g., pass/fail based on predefined criteria in the standards).

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

Not applicable. MRMC studies are used for diagnostic interpretation systems (often involving AI) to assess how human reader performance changes with or without AI assistance. This device is a physical sterilization tray.

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

Not applicable. This device is not an algorithm. Its "standalone" performance would be its functional performance as a physical object, which is what the non-clinical tests assess (e.g., its ability to withstand sterilization cycles, its material properties).

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is derived from several objective and validated methods:

• Sterility Assurance: Demonstrated by challenging the device with biological indicators (or similar methods) and showing complete kill of microorganisms, consistent with ANSI/AAMI/ISO 17665-1/2 standards.
• Physical Integrity & Functionality: Demonstrated by visual inspection, component dimensional fit verification, and functional closure verification after repeated cycles of cleaning and sterilization, as per "Life cycle (simulate usage) testing" guidance.
• Biocompatibility: Demonstrated by standardized cytotoxicity testing (ANSI/AAMI/ISO 10993-5) and broader biocompatibility assessment (ISO 10993-1).
• Cleanliness: Demonstrated by manual cleaning validation methods.

These methods establish the "truth" of the device's performance against recognized industry standards and regulatory guidance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no "training set" for this physical medical device.

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