(263 days)
The SteriTite® container system with MediTray products is a reusable 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 perforated base and perforated lid with filter retention plates, and disposable polypropylene filters. The Case Medical's SteriTite® container system and MediTray products are compatible with the TSO3 Inc.'s STERIZONE® VP4 Cycle 1 sterilization system for blades, lumened devices and flexible endoscopes.
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 Sterillite® container for use in STERIZONE® VP4(Cycle 1) is available with solid and 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 and lids and base are interchangeable for universal design. 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 document is a 510(k) premarket notification for a medical device (SteriTite® Container System & MediTray Products). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through a full clinical trial or extensive acceptance criteria study typical for AI/ML devices or new drug applications.
Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and specific ground truth methods as they would apply to an AI/ML or diagnostic device are not present in this document. This document describes a physical medical device (sterilization container) and its validation for use with a specific sterilization system, primarily through engineering and microbiological performance testing, not AI/ML model validation.
However, I can extract the information that is analogous or related to your request based on the context of this specific device and regulatory submission.
Here's an interpretation of the document in the context of your request, focusing on the available information:
- Device Under Review: SteriTite® Container System & MediTray Products (a reusable sterilization container system).
- Purpose: To enclose medical devices for sterilization, transport, and storage.
- Specific Compatibility: TSO3 Inc.'s STERIZONE® VP4 Cycle 1 sterilization system.
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to previously cleared predicate devices.
Analogous Acceptance Criteria and Reported Device Performance
Instead of AI/ML metrics (e.g., accuracy, sensitivity, specificity), the "acceptance criteria" here relate to the successful completion and negative results of various sterilization and physical performance tests. The "reported device performance" are the summary results of these tests.
Table of Acceptance Criteria (as inferred from performance testing) and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Lethality Study): Achieve Sterility Assurance Level (SAL) of $10^{-6}$ for surface, flexible, and rigid lumened devices. | "All results were negative." "Data obtained from representative samples of the SteriTite® perforated and solid base container line support SAL of $10^{-6}$ claims." (This implies 100% kill of test organisms in all tested scenarios). |
| Biocompatibility: Polypropylene filter and silicone brackets must not cause irritation; residual H2O2 levels must not exceed breathing zone. | "All results were negative." "In addition, levels of residual H2O2 on SteriTite components after processing in STERIZONE VP4 did not exceed the breathing zone." |
| Sterility Maintenance: Maintain sterility for a specified shelf life (e.g., 6 months) with handling events. | "Maintained sterility after a six month (180 days) real time with handling events. No growth was observed for the material used to absorb microorganisms of all the containers tested after 31 days and 6 months of shelf life. All the STERIZONE® BI+ Biological indicators placed in the containers were tested and were negative. All chemical indicators (CI+) were lighter than the reference color proving the sterilant penetrated the containers." |
| Material Compatibility & Durability (Reuse Testing): Withstand 100 consecutive cleaning and sterilization cycles without material degradation or loss of functionality. | "Validation of material compatibility and functionality was successfully performed after completion of 100 consecutive cleaning and sterilization cycles in STERIZONE® VP4 (Cycle 1)." |
| Microbial Barrier (Microbial Challenge Test): Maintain integrity as a microbial barrier after extensive exposure to sterilant (100 cycles) and an aerosol challenge. | "Testing was performed following the exposure to 100 STERIZONE VP4 sterilization cycles... Samples were then subjected to an aerosol challenge ($10^6$ Bacillus Atrophaeus CFU/ml). Each sample met the sterility maintenance requirement as there was no growth at the end of the incubation period." (This implies successful prevention of microbial ingress). |
| Stacking Capability/Strength: Containers must withstand stacking during storage and transport. | "Testing performed demonstrated that containers can be stacked during storage and transport." |
| Free Fall Impact: Containers must withstand accidental dropping. | "Testing performed demonstrated that container can withstand accidental dropping." |
| Handle Stress: Handles must support maximum load (56 lbs) without deformation. | "Testing performed demonstrated that container handles... are sufficiently robust to support the weight of the container with load (56 lbs.) without deformation." |
Information Not Applicable or Not Explicitly Stated in the Document (as pertaining to AI/ML or Diagnostic Studies):
As this is a physical sterilization container, not an AI/ML algorithm or diagnostic device, many of the requested fields are not relevant or are interpreted differently in this context.
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Sample sizes used for the test set and the data provenance:
- Test Set "Sample Size": The document refers to "representative samples" for validation. Specific numbers of units (e.g., "three inoculated single channel flexible endoscopes," "12 rigid or semi-rigid channeled devices") are mentioned for the sterilization load validation (Table 2), but not a distinct "test set" sample size in the traditional statistical sense for AI/ML validation or clinical trials.
- Data Provenance: The studies were conducted at "qualified independent laboratories," which implies controlled, experimental conditions for product validation, rather than retrospective or prospective patient data collection from a specific country.
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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. Ground truth for this device is established through microbiology (absence of microbial growth, SAL achievement) and engineering (physical integrity, weight limits), not expert adjudication of images or clinical findings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device validated for its primary function (sterilization).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Microbiological Ground Truth: Absence of microbial growth in biological indicators and inoculated test samples after sterilization cycles (for lethality and microbial barrier tests).
- Physical/Engineering Ground Truth: Measured physical integrity, lack of deformation, successful weight support for handles, maintenance of sterility (e.g., no growth observed).
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The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that undergoes "training."
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How the ground truth for the training set was established: Not applicable.
In summary, the document details the performance testing of a physical medical device (sterilization container) to demonstrate its safety and effectiveness. The "acceptance criteria" are implied by the successful completion of these rigorous physical and microbiological validation tests, often adhering to industry standards like AAMI ST77. The document clearly states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' was completed," and "The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available AAMI standards." This is the core of "proving the device meets the acceptance criteria" in this regulatory context.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).