(248 days)
The Aesculap Sterilcontainer is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the Sterrad 1005.
The Sterrad Compatible Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the Sterrad sterilization processes (100S). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.
This document is a 510(k) summary for the AESCULAP STERILCONTAINER FOR STERRAD, a reusable sterilization container system. It aims to demonstrate substantial equivalence to previously marketed devices. The performance data section states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Sterrad Compatible Aesculap Sterilcontainer was completed." It also claims that "Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market."
However, the provided text does not include specific acceptance criteria or detailed study results that would allow for a complete description fitting the requested format. It only states that testing was completed and found to be substantially equivalent. There is no information on sample sizes for test or training sets, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance.
Therefore, based on the provided text, a comprehensive answer to your request cannot be fully generated.
Based only on the provided text, here is what can be extracted, acknowledging the significant gaps in information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Sterilization testing results demonstrate substantial equivalence to other Sterilization Containers currently on the market. |
| Not specified in the document | The device is compatible for use with the Sterrad 100S sterilization process. |
Missing Information: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Sterrad Compatible Aesculap Sterilcontainer was completed." However, it does not detail what these "required tests" or their specific acceptance criteria were.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document generally describes a submission to the FDA for a device manufactured by Aesculap, Inc. in Center Valley, PA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was mentioned. This device is a sterilization container, not an AI-powered diagnostic tool, so an MRMC study and human reader improvement are not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device (sterilization container), not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant.
7. The type of ground truth used:
- The document implies that "Sterilization testing results" served as the basis for performance evaluation. For a sterilization container, ground truth would likely be established through direct microbiological testing to confirm sterility and maintenance of sterility, and physical compatibility tests with the specified sterilizer (Sterrad 100S). However, the specific methodology and outcomes are not detailed.
8. The sample size for the training set:
- Not applicable/Not specified. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not specified. (See point 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).