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Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:

• o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time.
  The trays are intended for sterilization of metal and thermoplastic loads.

Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.
Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).

• Injection molding sterilization cassettes ●
• Machined sterilization cassettes ●

The provided text describes the Klockner Surgical Box, a set of sterilization cassettes, and its regulatory clearance (K173642). It focuses on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than clinical data or AI algorithm performance.

Therefore, the requested information regarding AI algorithm performance metrics (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of human readers with AI assistance) is not applicable to this document. This document pertains to the physical and functional performance of a medical device (sterilization cassettes) and not an AI-powered diagnostic or assistive tool.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, based on the provided non-clinical performance testing.

1. Table of acceptance criteria and the reported device performance:

The document describes performance tests in "Table 5.1 Brief description of non-clinical performance testing" on page 11. The "Results" column essentially serves as the reported device performance, and the context of the "Standard(s) used" implies the acceptance criteria defined by those standards.

2. Sample sized used for the test set and the data provenance:

The document states that "Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases" for the validation tests. This implies that these specific models were used as representatives for the entire Klockner Surgical Box line. The exact number of units of these "worst-case" models used for testing is not explicitly stated, but it refers to "the kits" for the limits of reuse test.

• Test Set Sample Size: Represented by "Surgical Box Kit Klockner" and "Bone Space Maintainers Box Kit" as worst-case containers. The precise number of these kits tested is not provided, other than "the kits" for reuse.
• Data Provenance: The tests were carried out to demonstrate compliance for the device manufactured by Soadco, S.L. in Andorra, implying the tests were conducted for this device and potentially at their facility or a contracted lab. The document does not specify if the data is retrospective or prospective, but given it's for premarket notification, it would be data collected specifically for this submission.

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

This information is not applicable. The study is a non-clinical performance evaluation of a physical sterilization device, not an AI model that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be defined by the rigorous standardized methods of the cited regulatory standards (e.g., absence of microbial growth, visual cleanliness, material integrity after cycles).

4. Adjudication method for the test set:

Not applicable, as it pertains to expert consensus for AI model evaluation, which is not relevant here. The evaluation methods for the device performance tests would follow the protocols of the cited standards.

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 study for a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a non-clinical study for a physical device, not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is based on objective, quantifiable measures and methodologies prescribed by recognized international and national standards:

• Cleaning validation: Visual inspection and quantifiable cleaning measures (e.g., residual soil detection).
• Steam sterilization validation: Absence of microbial growth in biological indicators after sterilization.
• Limits of reuse: Meeting inspection and performance criteria (e.g., material integrity, functionality) after a specified number of reprocessing cycles.
• Drying time: Visual and quantifiable dryness.

8. The sample size for the training set:

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

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