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The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be:

• wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems ● or
• placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.

The Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterilization Trays.

Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.

The Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 10-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate V-PRO Sterilization Tray (K140494) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices.

Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 10-2 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a Sterilization Tray.

Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 10-3 to fit the nine Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.

The provided document is a 510(k) premarket notification for "Sterilization Trays" by STERIS Corporation. It outlines the device's intended use and includes a summary of nonclinical tests performed to demonstrate substantial equivalence to a predicate device.

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

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

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

The document does not specify the exact sample sizes (e.g., number of trays, number of sterilization cycles) used for each test. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). However, given that this is a 510(k) submission to the FDA, it is prospective testing conducted by the manufacturer, STERIS Corporation, likely in the USA, to support the device's market clearance.

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 provided in the document. The tests described are laboratory-based performance tests (e.g., sterilization effectiveness, material compatibility, cleaning efficacy), not diagnostic accuracy studies requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense may not directly apply here. Instead, ground truth would be established by validated analytical methods and scientific standards within a laboratory setting.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting data (e.g., medical images). Since the tests described are laboratory performance tests for a sterilization tray, an adjudication method for interpretations is not applicable and therefore not mentioned. Results would be determined by objective measurements and passing/failing pre-defined technical criteria (e.g., presence/absence of microbial growth, chemical residue levels, visual assessment of functionality).

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as the device (sterilization tray) is not an AI-powered diagnostic tool involving human readers. The document details performance tests for physical sterilization equipment, not AI assistance for human interpretation.

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

A standalone algorithm performance study is not applicable as the device is a physical sterilization tray, not an algorithm or AI system.

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

The ground truth for the performance tests would be established through scientific and objective measurements based on established standards and methods relevant to sterilization and material science. For example:

• Effective Sterilant Penetration: Ground truth would be the absence of microbial growth on biological indicators or test articles after sterilization, as per established sterilization protocols (e.g., ISO standards, AAMI guidelines).
• Effective Drying and Aeration: Ground truth would be hydrogen peroxide levels below a pre-determined safe threshold, measured using chemical analysis.
• Effective Cleaning: Ground truth would involve visual inspection and potentially chemical analysis to confirm removal of soil and contaminants according to established cleaning validation protocols.
• Material Compatibility: Ground truth would be the visual assessment or mechanical testing to confirm the trays and accessories retain their functionality and integrity after repeated sterilization cycles.
• Biocompatibility: Ground truth would be the absence of cytotoxic effects, determined by standardized in vitro (e.g., cell culture) or in vivo biocompatibility tests.

8. The sample size for the training set:

A training set is relevant for machine learning or AI models. Since this device is a physical sterilization tray and not an AI system, the concept of a "training set" is not applicable.

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

As implied by point 8, a training set is not applicable for this device.

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