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The SteriTite® container system with MediTray® products is a rigid reusable sealed sterilization container system used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. The container consists of a solid or a perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use.

The SteriTite® container has been validated for prevacuum sterilization at 132°C for 4 minutes. with 3 stainless steel (3mm inner diameter × 400mm length) and 3 porous lumens (2mm inner diameter × 400mm length), and representative products of the MediTray line of accessories such as: insert boxes, multilevel tray systems, instrument baskets (stacked and single level) with various inserts including brackets, posts, and partitions. The container may be used for sterilization of medical devices including full instrument sets, stacked trays, and mixed loads.

Additionally, the SteriTite® container has been validated for prevacuum sterilization at 134℃ for 4 minutes using tabletop autoclaves for metal instrument loads with 5 stainless steel lumen (2mm ID × 250mm length).

The following claims have been validated for this device:
· One (1) Year sterile shelf life/maintenance of sterility claim:
· Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units.
· Compatibility with Table Top Pre-Vacuum Steam SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.

The SteriTite® container system is recommended to be used for sterilization of medical devices.

The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The provided text describes the acceptance criteria and supporting studies for the Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories. However, it is primarily focused on the validation of the container system itself and its ability to maintain sterility and achieve a dry outcome.

The concept of "device performance" in this context refers to the container's ability to:

1. Maintain sterility for a specified shelf life.
2. Achieve a dry load after sterilization with reduced dry times.
3. Be compatible with various sterilization methods, including tabletop pre-vacuum steam sterilization.

The text does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness for diagnostic or screening purposes. Therefore, questions related to test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

Here's an attempt to answer the relevant questions based on the provided text:

1. Table of Acceptance Criteria and 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)

This device is a physical sterilization container, not a data-driven device. Therefore, the concept of a "test set" for data provenance as it applies to AI/ML devices is not applicable. The studies performed are physical validation tests.

For the shelf-life study, "Containers representative of SteriTite line of product" were challenged, but the exact number is not specified in the provided text. The reduced dry time study also refers to "numerous shorter dry time studies" in-house and subsequent "independent laboratory validated the outcome." For tabletop sterilization, the study used "two solid bottom containers."

The data provenance is from laboratory studies conducted by Case Medical, Inc. and subsequently validated by a qualified independent laboratory. The country of origin of the labs is not explicitly stated, but the submission is to the U.S. FDA. These are prospective validation studies designed to test the specific claims.

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)

Not applicable. This is not an image-based diagnostic or AI/ML device where expert consensus is used to establish ground truth for a test set. The validation relies on scientific and engineering tests (e.g., microbial challenge, moisture detection, lethality studies) conducted by qualified laboratory personnel and based on established standards (ASTM, AAMI, FDA guidance).

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

Not applicable for a physical device validation. The "ground truth" for sterility is determined by microbial growth (or lack thereof) and for dryness by the absence of residual moisture. These are objective, measurable outcomes, not subjective interpretations 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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth for the validation studies is based on:

• Absence of Microbial Growth: For the sterile shelf-life claim, the ground truth is established by the lack of microbial growth after a whole package microbial aerosol challenge, indicating sterility maintenance.
• Absence of Residual Moisture: For the reduced dry time claim, the ground truth is the confirmed absence of residual moisture after the sterilization and drying cycle.
• Sterilization Efficacy (Lethality): For the compatibility with tabletop sterilizers, the ground truth relates to the effective sterilization of challenge devices (e.g., lumens) within the container, indicating that the sterilization process achieved its intended lethality.

These ground truths are determined through established laboratory testing protocols and standards (ASTM, AAMI, FDA guidance).

8. The sample size for the training set

Not applicable. There is no AI/ML model for this device, and thus no "training set."

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

Not applicable, as there is no training set for an AI/ML model.

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