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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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