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The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time).

When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used.

The system has been validated with devices with working channels >= 0.2mm and a maximum length of 240mm.

The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization. the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.

The tray configurations are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware.

The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.

The document describes the acceptance criteria and the results of non-clinical testing for the KARL STORZ Metal Sterilization Trays. It does not describe a study involving a medical device that uses artificial intelligence or machine learning. Therefore, many of the requested elements of the response (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for the training set) are not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table.

Here's the relevant information that can be extracted:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to non-clinical testing performed with the subject device and standards used, but details on sample sizes for specific tests or data provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical performance and safety testing of a physical medical device (sterilization trays), not an AI/ML diagnostic or prognostic device that would require expert-established ground truths.

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

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study is not applicable as the device is a sterilization tray, not an AI-assisted diagnostic tool.

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

Standalone performance refers to AI algorithm performance. This is not applicable to the KARL STORZ Metal Sterilization Trays.

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

For the non-clinical tests described, the "ground truth" is established by the specified standards and test methods (e.g., AAMI ST77, ISO 17665-1, AAMI TIR 30, ISO 10993-5) which define what constitutes a "passed" result based on quantifiable metrics (e.g., 10-6 SAL, weight difference <3%, specific protein/hemoglobin concentrations, no evidence of lysis). These are objective measurements rather than expert consensus on a clinical diagnosis.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML product that would require a training set.

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

This information is not applicable for the same reasons as point 8.

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The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes).

The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.

KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.

The KARL STORZ-ENDOSCOPE RADEL Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.

The tray configurations, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat.

The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray.

The provided text describes a 510(k) premarket notification for Karl Storz Radel Sterilization Trays and details non-clinical testing performed to demonstrate the device's safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents a "Summary of Non-Clinical Testing" which acts as the study proving the device meets the acceptance criteria. The table below excerpts the relevant information:

Table 1: Acceptance Criteria and Reported Device Performance

Study Details:

Based on the provided text, primarily the "Summary of Non-Clinical Testing" and related sections, here are the answers to the specific questions:

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

   • See Table 1 above.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: The document does not specify the numerical sample sizes (e.g., number of trays, number of cycles, number of cleaning tests) used for any of the non-clinical tests. It only states what was "validated" and with which instruments (e.g., "validated with a miniature scope with an irrigation channel lumen diameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm").
   • Data Provenance: The document does not explicitly state the country of origin of the data. The submitting organization, KARL STORZ Endoscopy-America, Inc., is based in El Segundo, California, USA, and the consultant is in Austin, Texas, USA. Given this is an FDA 510(k) submission, it's presumed the studies were conducted to meet US regulatory requirements. The studies are non-clinical bench testing, not retrospective or prospective human clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This question is not applicable to this type of non-clinical device testing. The ground truth for performance (sterilization efficacy, dry time, cleaning effectiveness, biocompatibility) is established through adherence to recognized international and national standards (AAMI ST77, ISO 17665-1, AAMI TIR 30, ISO 10993-5) and standardized laboratory testing protocols, rather than expert consensus on medical images or clinical outcomes.

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

   • This is not applicable as the testing involves objective measurements against predefined acceptance criteria from standards, not subjective assessments requiring 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

   • This is not applicable. This document describes non-clinical performance testing of a sterilization tray, not an AI/imaging device requiring MRMC studies.

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

   • This is not applicable. This document describes non-clinical performance testing of a sterilization tray, not an AI/imaging device. The "standalone" performance here relates to the device's ability to meet the specified performance criteria (e.g., achieving 10^-6 SAL), which is indeed what was tested.

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

   • The "ground truth" for the non-clinical tests is based on defined performance metrics and thresholds established by recognized national and international standards (e.g., 10^-6 SAL for sterilization, <3% weight difference for drying, specific µg/cm² limits for protein/hemoglobin, and no evidence of lysis for cytotoxicity). It's objective, quantitative data derived from laboratory testing, not subjective clinical or pathological assessments.

8. The sample size for the training set

   • This is not applicable. The device is a medical device (sterilization tray), not an AI algorithm that requires a training set.

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

   • This is not applicable as there is no AI algorithm training set.

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