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The perforated base containers are part of a line of the SteriTite @ Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers have been validated for use in STERRAD 100S Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100S Sterilization for a hospital or other health care facilities.

Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization.

• Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers.
• Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters.
• Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers.
• Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm.

The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100S Sterilization for a hospital or other health care facilities.

• After each sterilization cycle the filters must be discarded. -
• Before each sterilization cycle use new filters. -

The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective stcrilization packaging method for operating room instruments. The SteriTite® perforated base containers include a vented base and a vented lid with filter retention plates. The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filltration system that allows effective penetration by the sterilant. The SteriTite® perforated base containers with baskets have been validated for surfaces and lumens in STERRAD 100S Sterilization. For STERRAD 100 and 100S Sterilization each stainless stccl filter retention plate secures a disposable round non-woven polypropylene disposable bacterial filter. Silicone gaskets are permanently attached to the filter retention plates and lid with silicone adhesive. A stainless stcel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.

The disposable filter # SCF02 is a nonwoven polypropylene material.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the SteriTite® perforated base rigid reusable sterilization container system with SCF02-polypropylene non-woven Disposable Filter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "sample size" in terms of a number of cases or patients for a test set in the traditional sense of a clinical trial. Instead, the testing likely involved a series of controlled laboratory experiments and challenges.

• Test Setup: Containers in combination of 10" in total height or 8" high for any one container were tested. The testing involved "blades and lumens" and "inoculated blades" and "inoculated lumens." The text mentions "STU load" which refers to a Steam Sterilization Unit test load, a standardized challenge often used in sterilization efficacy testing. It also references "occlusions were added" for STERRAD 100S testing.
• Provenance: The studies were performed domestically, likely in the US, as indicated by the submission to the FDA and reference to US standards (AAMI). They were conducted as "performance testing" and "additional studies," suggesting controlled laboratory environments rather than retrospective or prospective human patient data. The independent testing was conducted by ASP.

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

This information is not provided in the document. The ground truth for sterilization efficacy is typically established through verifiable biological indicators (e.g., absence of microbial growth) and chemical indicators, observed and interpreted by microbiologists, sterilization experts, or laboratory personnel, not clinical experts like radiologists.

4. Adjudication Method for the Test Set

This information is not applicable to this type of study. Sterilization efficacy studies do not typically involve adjudication methods like 2+1 or 3+1, which are common in clinical imaging studies with human readers. The "ground truth" is determined by direct scientific measurement (e.g., biological indicator kill, chemical indicator change).

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for evaluating the effectiveness of a sterilization container. The device's performance is assessed based on its ability to sterilize instruments, not on how human readers interpret images or data assisted by AI.

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

Yes, in essence, a standalone performance assessment was done. The performance of the "SteriTite® Container with non-woven polypropylene filter" was evaluated directly for its ability to achieve sterilization (microbial inactivation) in the STERRAD 100S System, independent of human interaction during the sterilization cycle. The "efficacy" was "clearly demonstrated" using an "overkill method," biological indicators (Bacillus Stearothermophilus), and half-cycle conditions.

7. The Type of Ground Truth Used

The ground truth used for this study was primarily derived from biological indicators (BI) and likely chemical indicators (CI), indicative of successful microbial inactivation and sterilant penetration. Specifically:

• Microbial Inactivation: The testing organism was Bacillus Stearothermophilus, and inoculated spore carriers with 1 x 10^6 B. Stearothermophilus were used. The "overkill method" also points to this. The "efficacy" for blades and lumens implies the successful killing of these organisms.
• The text makes it clear that "the efficacy... was clearly demonstrated," which is the ground truth.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The device itself (the sterilization container) is the subject of validation.

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

This information is not applicable/not provided as there is no training set for an algorithm.

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