(188 days)
The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterlity of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.
The Sterilucent Self-Seal Sterilization Pouch is a self sealing pouch used to enclose another medical device that is to be sterilized by a healthcare provider. It is available in sizes to suit the healthcare provider. Devices are inserted into the pouch, sealed, and then sterilized in the Sterilucent low temperature vaporized hydrogen peroxide (VHP) process. After completion of the sterilization process, the pouch maintains sterility of the enclosed medical devices until the seal is opened.
The pouches are constructed of a Tyvek backing with a clear, laminated polyethylene terephthalate (PET)/low density polyethylene (LDPE) film material front. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment.
The provided text describes the Sterilucent Self-Seal Sterilization Pouch and its non-clinical performance data. Here's an analysis of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes the outcome of studies, stating that "all acceptance criteria were met."
However, we can infer criteria and performance from the "Summary of Non-Clinical Performance Data" section:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Sterilization Efficacy | A 12 log reduction achieved, resulting in a Sterility Assurance Level (SAL) of 10-6. |
| Shelf Life | Sterility maintenance demonstrated for a 180-day time period. |
| Microbial Barrier Properties | Appropriate microbial barrier properties demonstrated. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the number of pouches used for each test.
The data provenance is from non-clinical studies, which typically means laboratory testing rather than human patient data. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the studies are non-clinical, it's unlikely that "experts" in the sense of clinical specialists were used to establish ground truth. Ground truth for sterilization efficacy and microbial barrier properties would typically be established by established microbiological testing standards and results.
4. Adjudication method for the test set
This information is not provided as it's not applicable to non-clinical laboratory tests as described. Adjudication methods like "2+1" are typically used for interpreting human-read data (e.g., medical images).
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools with human readers, which is not the nature of this device (a sterilization pouch).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Sterilucent Self-Seal Sterilization Pouch. This device is a physical product (a pouch) used in a sterilization process, not an algorithm or AI system. Its performance is evaluated through its physical and biological properties.
7. The type of ground truth used
The ground truth used for the non-clinical studies was based on:
- Biological Indication (BI) overkill method and half-cycle validation: For sterilization efficacy (determining a 12 log reduction and SAL of 10-6).
- Real-time event-related shelf life studies: For sterility maintenance over time.
- Whole package microbial challenge testing: Exposing pouches to a specified concentration of Bacillus atrophaeus CFU to assess microbial barrier properties.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of validating a medical device like a sterilization pouch, as it's not an AI or machine learning model. Its performance is evaluated through physical and biological testing.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
§ 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).