(411 days)
The SteriTite universal 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 SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.
SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).
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 is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamper evident seals. A filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts are available for instrument management. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.
Please note that the provided text is a 510(k) Summary for a medical device approval, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to an already cleared device rather than presenting a comprehensive clinical trial or acceptance testing study against pre-defined performance criteria for a novel device. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, and ground truth establishment details) is not present in this document because it's typically not required for a 510(k) submission based on substantial equivalence.
However, I can extract the information that is present and indicate where the requested details are not available or applicable based on the nature of this document.
Acceptance Criteria and Device Performance (Interpreted from the document's claims about sterility assurance)
The document implicitly defines acceptance criteria based on the ability to achieve sterility (elimination of a biological challenge) using the "overkill method." The performance stated is that this method was followed and successfully demonstrated.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sterility Assurance (elimination of a biological challenge) via "overkill method" | Microbial challenge testing showed successful elimination of a biological challenge. |
| Sterilization of specific lumens (3mm x 400mm) | Lumens of 3mm diameter x 400mm length were successfully tested. |
| Compatibility with MediTray products and various container sizes | All listed MediTray products and container sizes (SC03MG to SC05WG) are compatible and underwent testing. |
| Use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle | The system is indicated and tested for use in this specific sterilization system. |
| Ability to prevent strike-through | Vent holes are offset to prevent strike-through. |
1. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "All containers were tested" and "Furthermore, sample containers were validated," but specific numbers are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Case Medical, Inc. based in Ridgefield, NJ, USA. It is prospective testing designed to support the 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not stated. This type of testing (microbial challenge) typically relies on laboratory methods and established sterility assurance levels rather than expert consensus on imaging or clinical outcomes.
- Qualifications of Experts: Not applicable or not stated.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Sterility testing by biological indicators and inoculated products follows laboratory protocols for pass/fail criteria, not a consensus-based adjudication process.
4. 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:
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly not done. This device is a sterilization container, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a passive sterilization container; it does not involve algorithms or human-in-the-loop processing in the context of AI. The performance demonstrated is the efficacy of the container system in achieving sterility.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for sterility was established using microbial challenge testing with biological indicators and inoculated products. This is a scientific and standardized method for assessing sterilization efficacy, aiming for the "elimination of a biological challenge," indicating a certain sterility assurance level (SAL).
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This submission is for a physical medical device (sterilization container), not an AI/machine learning algorithm requiring a "training set."
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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).