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The THS Sterilization Tray is used to enclose, protect, and organize the THS scopes, diagnostic sheath, and associated accessory components, and to facilitate the sterilization process by allowing sterilant penetration and air removal when used in conjunction with an approved sterilization wrap.

The THS Instrument tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap sterility of the enclosed medical device is maintained based on the specific time that the maintenance of sterility for that specific wrap as cleared by the FDA.

The THS Sterilization Tray is to be sterilized using one of the following cycles:

Steam Autoclave Wrapped Pre-Vacuum Parameters: 270°F for 4 minutes
Pre-Vacuum Dry Time: 30 minutes
Gravity Parameters: 250°F for 30 minutes
Gravity Dry Time: 30 minutes

The THS Sterilization Tray will secure the reusable THS components during autoclave sterilization in preparation for future procedures. The THS Sterilization Tray described in this submission contains no components or materials that directly contact the patient and/or patient body fluids.

Here's an analysis of the provided text regarding the THS Sterilization Tray, focusing on 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 provided text does not explicitly state a quantitative sample size for a "test set" in the traditional sense of a clinical or performance study involving human subjects or a large dataset. The performance testing described is likely based on laboratory validation of the sterilization parameters.

• Sample Size: Not specified.
• Data Provenance: The study is an internal validation conducted by Hologic, Inc. (the manufacturer). The country of origin would be the USA (Marlborough, MA). It is a prospective assessment in the sense that the device was specifically tested to confirm its compatibility with the sterilization cycles.

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

This information is not provided in the document. For a sterilization tray, "ground truth" would typically be established by established sterilization standards and validated by microbiological or chemical indicator testing performed by qualified laboratory personnel, rather than medical experts in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 typically apply to studies where human reviewers assess data (e.g., medical images) and disagreements need to be resolved. For a sterilization tray, performance is assessed against predefined physical and microbiological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a sterilization tray, not a diagnostic tool requiring human interpretation of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, a standalone validation was done. The performance testing described (Section 7: "Performance Testing") assesses the device's ability to withstand and facilitate the sterilization process according to specified parameters, independent of human interaction during the sterilization cycle itself. While there's no "algorithm" in the sense of AI, the device's intrinsic characteristics are tested in a standalone manner.

7. The Type of Ground Truth Used

For a sterilization tray, the "ground truth" would be the successful completion of the sterilization process, demonstrating:

• Sterilant Penetration: Evidence that the sterilant reached all surfaces within the tray.
• Air Removal: Confirmation that air was effectively removed, allowing proper sterilant contact.
• Maintenance of Device Integrity: The tray and its contents withstand the sterilization cycles without damage.
• Microbiological Inactivation: (Implied by standard sterilization validation) Assurance that a sterility assurance level (SAL) is achieved, typically through the use of biological indicators in conjunction with the validation of the chosen sterilization cycles.

The document states the tray "has been validated to be sterilized using" the specified cycles, implying that these aspects of ground truth were confirmed.

8. The Sample Size for the Training Set

This information is not applicable or provided. The THS Sterilization Tray is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven model development.

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

This information is not applicable or provided for the reasons stated above (no training set for a physical device).

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