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This instrument tray is intended to be used to enclose and protect Olympus flexible endoscopes during sterilization. The instrument tray is designed to hold one endoscope at a time and is to be used in conjunction with an FDA cleared sterilization wrap for ethylene oxide sterilization. The instrument tray is an optional accessory to the Olympus endoscopes for which it is designed. Maintenance of sterility depends on the sterilization wrap, not on the instrument tray. This instrument tray is indicated for ethylene oxide sterilization of only compatible Olympus endoscopes. For compatible endoscopes, refer to the table below, "Compatible Olympus Endoscopes".

The Olympus Instrument Tray is comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage.

This document describes the Olympus Instrument Tray, intended to protect flexible endoscopes during ethylene oxide (EtO) sterilization. The study focuses on demonstrating the tray's effectiveness in allowing proper sterilization and aeration of endoscopes.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Worst-Case Endoscope (URF-P5): Sterilized successfully in a 30-minute half cycle, demonstrating 6-log reduction capability (SAL of 10^-6^). |
  | Ethylene Oxide Residuals | Residual concentrations of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) must be within acceptable limits after a 12-hour aeration time, pursuant to ISO10993-7. | - Instrument Tray: Residual concentrations of EO and ECH were all within acceptable limits after 12 hours of aeration.
• Worst-Case Endoscope (URF-P5): Residual concentrations of EO and ECH were all within acceptable limits after full cycles and appropriate aeration. |
  | Biocompatibility | Material (Radel-R) meets the requirements for biocompatibility pursuant to ISO-10993. | The trays are constructed of biocompatible Radel-R, which meets the requirements for biocompatibility according to ISO-10993. |
  | Risk Analysis | Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. | Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. (No specific performance data is provided here, just that the process was followed.) |

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

• Sample Size: The document does not explicitly state the numerical sample size for the test set (number of trays or endoscopes tested). However, the testing involved:
  • "worst case component load" for the instrument tray validation.
  • "worst case endoscope (URF-P5)" for the endoscope validation. This implies at least one URF-P5 endoscope was tested, along with an unspecified number of biological indicator organisms and chemical indicators.
• Data Provenance: The data appears to be prospective as it describes validation testing performed specifically for this submission. The country of origin of the data is not specified, but the applicant and manufacturer are based in Germany, and the correspondent in the USA.

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

• The document does not mention the use of external experts to establish ground truth for the test set. The ground truth (successful sterilization defined by 6-log reduction and acceptable residual levels) was established through objective laboratory testing using FDA cleared biological indicator organisms and chemical indicators, in conjunction with relevant ISO standards.

4. Adjudication Method for the Test Set

• No adjudication method is described, as the evaluation relies on objective laboratory measurements (biological indicator kill, residual chemical levels) rather than subjective human interpretation.

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 device is an instrument tray, not an AI or imaging device that involves human readers or interpretation of results. Therefore, an MRMC comparative effectiveness study was not applicable and not done.

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

• This device is an instrument tray, not an algorithm or AI system. Therefore, a standalone performance study as typically understood for AI was not applicable and not done. The "standalone" performance here relates to the physical and chemical performance of the tray itself in facilitating sterilization.

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

• The ground truth used for both sterilization effectiveness and residual testing was based on objective biological and chemical indicators and adherence to established regulatory standards (SAL of 10^-6^ and ISO 10993-7).
  • For sterilization: 6-log reduction in biological indicators.
  • For residuals: Measurement of EO and ECH concentrations within acceptable limits.

8. The Sample Size for the Training Set

• This device does not involve a "training set" as it is not an AI/machine learning device. The validation is based on physical and chemical testing described above.

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

• Not applicable, as there is no training set for this device.

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