(402 days)
The SteriSet Sterilizatoin Conatiner is intended to be used to ecnlose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".
The containers are used for holding operating room instruments and/or textiles during vacuum-steam sterilization procedures and for maintaining sterility during storage and transport under proper hospital conditions.
This document is a 510(k) Summary for the Wagner SteriSet Sterilization System. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data for a new device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies is largely not applicable to this type of regulatory submission in the provided text.
The document states: "The containers are identical to the Medline (K010825) and AMSCO (K823902) in design, materials, and intended use. All containers (Medline and AMSCO included) are manufactured by Wagner GmBH." This is the core argument for substantial equivalence, implying that since the predicate devices have established efficacy and safety, the identical Wagner device also meets those unstated criteria.
Here's a breakdown of what can be extracted or inferred from the provided text, and what is absent:
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A table of acceptance criteria and the reported device performance:
- Not applicable/Not provided directly. The document does not specify quantitative acceptance criteria (e.g., specific sterilization efficacy rates or sterility maintenance periods with numerical targets) or report performance against such criteria. The entire submission hinges on demonstrating "substantial equivalence" to predicate devices, meaning it is assumed to meet the same, unstated performance requirements as those predicates.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. There is no mention of a specific "test set" or experimental data from a study with a sample size for the Wagner SteriSet containers themselves. The reliance is on the substantial equivalence to predicate devices, which presumably underwent their own validation studies at the time of their clearance.
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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/Not provided. As no specific 'test set' or ground truth establishment study for the Wagner SteriSet is described, there's no mention of experts for this purpose.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. See point 3.
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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 a sterilization container, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. For substantial equivalence, the "ground truth" is essentially that the predicate devices were deemed safe and effective based on their original reviews and market history.
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The sample size for the training set:
- Not applicable/Not provided. There is no machine learning model or "training set" for this device.
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How the ground truth for the training set was established:
- Not applicable/Not provided. See point 8.
In summary, the provided text from the 510(k) Summary explicitly focuses on demonstrating substantial equivalence based on design, materials, and intended use being identical to legally marketed predicate devices, not on presenting novel performance study data for the Wagner SteriSet. Therefore, the detailed study-related information requested is largely absent because it's not the purpose of this specific type of regulatory document.
§ 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).