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The Omni Instrument Tray is intended to enclose, protect, and organize the Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. The Omni Instrument Tray has been validated for the following sterilization cycles: Prevacuum Steam 132°C (270°F) 4 minutes exposure 35 minutes dry time Contents: - 1 Omni Hysteroscope - 1 Removable Outflow Channel - 1 XL Removable Outflow Channel - 1 Omni 3.7mm Diagnostic Sheath - 1 Omni 5.5mm Operative Sheath - 1 Omni 6mm Operative Sheath - 3 Seal Caps - 2 Light Guide Adapters STERRAD ® - STERRAD 100S Short - STERRAD NX Standard - STERRAD 100NX Standard Contents: - 1 Omni Hysteroscope - 1 Removable Outflow Channel - 1 XL Removable Outflow Channel - 1 Omni 3.7mm Diagnostic Sheath - 1 Omni 5.5mm Operative Sheath - 1 Omni 6mm Operative Sheath - 3 Seal Caps - 2 Light Guide Adapters

The Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. The Omni Instrument Tray is made of a stainless steel, santoprene, and silicone and is supplied non-sterile and is designed for multiple use for the sterilization of the Omni Hysteroscope set prior to each use of the Hysteroscope.

The Omni Instrument Tray is intended to enclose, protect, and organize the Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. It must be used with an FDA-cleared sterilization wrap. The device was validated for Prevacuum Steam at 132°C (270°F) for 4 minutes exposure and 35 minutes dry time, and STERRAD® cycles (100S Short, NX Standard, 100NX Standard).

Here is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical bench testing and simulated use testing. Specific sample sizes for each test are not explicitly provided in the summary. The data provenance is described as being generated through "non-clinical bench testing and simulated use testing," implying in-house or contract lab testing, not involving human subjects or real-world patient data from specific countries. The testing is and can be considered retrospective to the device design.

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

Not applicable. The testing described is for a sterilization tray, focusing on engineering and biological performance. Ground truth for these types of tests is established by adherence to recognized standards and objective measurements (e.g., microbial kill, cytotoxicity, mechanical strength), not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. This device is not an AI diagnostic tool and does not involve human interpretation or adjudication of results in the traditional sense. Acceptance is based on meeting pre-defined criteria from relevant standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (sterilization tray), not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the form of non-clinical bench testing and simulated use testing. The document states that "non-clinical bench testing and simulated use testing demonstrate the Omni Instrument Tray is similar to the predicate device." This refers to the testing of the device itself (algorithm-only equivalent for a physical device) against established performance criteria, independent of human interaction during the test process beyond setting up the tests.

7. Type of Ground Truth Used:

The ground truth used for the performance testing is based on:

• Adherence to recognized industry standards: e.g., ISO 10993-5:2009 for biocompatibility, IEC 62366-1:2015 for usability, ISTA 3A for packaging, ANSI/AAMI ST77:2013 for containment, AAMI TIR12:2010 for durability, AAMI TIR30:2011 for cleaning.
• Objective measurements and criteria: such as the absence of cytotoxicity, successful completion of sterilization cycles (implied by meeting the standards for sterilizers), confirmed fit of components, and ability to withstand specified mechanical forces.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device (sterilization tray), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

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

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