(113 days)
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:
- In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
- In STERRAD 100NX Flexible cycle, process flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm.
120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.
Reuse testing was performed after 501 STERRAD 100NX Standard cycles.
The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for STERRAD 100NX has perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. 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 describes a 510(k) premarket notification for the "SteriTite Universal Container System with MediTray Products for STERRAD 100NX". This is a medical device for sterilization packaging, not an AI/ML powered device, therefore, many of the typical acceptance criteria and study components like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of AI/ML.
However, based on the information provided for this non-AI/ML medical device, here's a breakdown of the available details:
Acceptance Criteria and Device Performance for SteriTite Universal Container System
The acceptance criteria for this device are implicitly tied to its compatibility and effectiveness in sterilization with the STERRAD 100NX system. The study conducted validated this compatibility and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly list quantified "acceptance criteria" for each performance metric in a pass/fail sense, as would be typical for an AI/ML model. Instead, it describes validated compatibility and performance. The "reported device performance" indicates that these conditions were successfully met.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compatibility with STERRAD 100NX Sterilizer (Standard Cycle) | Validated for use with STERRAD 100NX Standard cycle for various container sizes (Full-size, Mid-size, Half-size, Mini-long, Mini-size) and associated MediTray products and accessories. Tested with 10 stainless steel lumens. |
| Compatibility with STERRAD 100NX Sterilizer (Flex Cycle) | Validated for use with STERRAD 100NX Flex cycle for various container sizes (Full-size, Mid-size, Half-size, Mini-long, Mini-size) and associated MediTray products and accessories. Tested with 1 flexible lumened device plus inserts per container. |
| Sterilization of Stainless Steel Lumens (Standard Cycle) | Effective for processing stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length. |
| Sterilization of Flexible Lumens (Flex Cycle) | Effective for processing flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm. |
| Shelf-life after Sterilization | Achieved 120 days of real-time shelf life, including handling events, after STERRAD 100NX sterilization. |
| Reuse Capability | Demonstrated effective performance after 501 STERRAD 100NX Standard cycles. |
| Compatibility with Specific MediTray Products | Validated for use with Baskets, Trays, Insert Boxes, Metal Brackets, Metal Partitions, Posts, Silicone Brackets, Racks, and Stringers. |
| Compatibility with Specific SteriTite Accessories | Validated for use with SCF02 Round filter, SCFM02 Rectangular filter, SCS01W Tamper Evident Seals, SCLH2023 Load Card Large, and SCLH2024 Load Card Small. |
Study Details (as applicable for a non-AI/ML device):
This section addresses the provided categories, noting when they are not relevant to this type of device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document specifies "10 stainless steel lumens" for Standard cycle validation and "1 flexible lumened device plus inserts per container" for Flex cycle validation (implicitly meaning multiple containers were tested). It also mentions "501 STERRAD 100NX Standard cycles" for reuse testing. The specific number of containers or load configurations tested for overall compatibility isn't explicitly stated but implied to be comprehensive for the listed products.
- Data Provenance: The validation testing was "conducted at qualified independent laboratories." The country of origin is not explicitly stated but the submission is to the FDA (USA). The study is prospective in nature, as it involves testing the device under controlled conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an AI/ML device. For this sterilization container, "ground truth" is established through standardized microbiological and physical testing methods (e.g., spore-kill assays, leak tests, sterility assurance level verification). The document states the testing was done "in accordance with FDA guidance and available AAMI standards," implying adherence to established scientific protocols rather than expert consensus on interpretive tasks.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of an AI/ML device. Adjudication methods are relevant for subjective interpretations, often in medical imaging. The validation here relies on objective measurements and established sterilization efficacy protocols.
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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 device is not an AI/ML system, and therefore, no MRMC study involving human readers and AI assistance was conducted.
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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 medical device, not an algorithm. Its performance is inherent to its design and material properties in conjunction with the sterilizer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" refers to the sterility assurance level (SAL), absence of microbial growth, and integrity/functionality of the container and its contents after sterilization and handling. This is established through validated, objective testing methods (e.g., biological indicators, chemical indicators, leak tests, material compatibility tests, shelf-life studies, reuse cycle testing) according to recognized standards (like AAMI).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for it.
§ 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).