(180 days)
Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.
Aesculap's Reusable Sterile Container Filters allows for thorough penetration and evacuation of sterilants, while maintaining an effective barrier against microbial contamination. The Ulters are circular in shape and can be used for up to 2,200 washing and sterlilization cycles. Aesculages Reusable filters are to be used in conjunction with Aesculan's Sterilcontainer System (K792558).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Reusable Sterilecontainer Filter.
It's important to note that the provided documents are a 510(k) Summary and FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies in the way one might see for novel AI/software devices. Therefore, many of the typical "acceptance criteria" and "study" elements you'd expect for an AI device are not explicitly present or are addressed differently in this context.
Acceptance Criteria and Reported Device Performance
Note: The provided document is a 510(k) summary for a physical medical device (a filter), not an AI/software device. As such, "acceptance criteria" here refers to the demonstrated performance aspects relevant to the device's function as a sterilization wrap, primarily barrier effectiveness and reusability. There are no performance metrics like sensitivity, specificity, or AUC that would be associated with an AI device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Barrier against microbial contamination | Effective barrier maintained through 2,200 uses. |
| Thorough penetration and evacuation of sterilant (steam) | Allows for thorough penetration and evacuation of sterilant. |
| Durability/Reusability | Maximum of 2,200 uses/washing and sterilization cycles. |
| Compatibility with Aesculap SterilContainer System | For use with Aesculap SterilContainer in prevacuum steam sterilization. |
| Sterilization Cycle Compatibility | For use at 273°F for 5 minutes (as per Indications for Use). |
Study Details (Based on the provided 510(k) Summary)
Given that this is a 510(k) for a physical filter, the "study" described is a demonstration of performance to support substantial equivalence, rather than a clinical effectiveness study. The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This implies that the 'study' likely involved in-house testing to demonstrate the claims made for the filter's performance (e.g., barrier integrity after multiple cycles).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided 510(k) summary. The claim is for "a maximum of 2,200 uses," which suggests that filters were subjected to at least this many cycles in testing. The number of individual filters tested is not mentioned.
- Data Provenance: Not specified. Typically, such testing would be conducted in a laboratory setting by the manufacturer (Aesculap®, Inc., which is based in Center Valley, PA, USA). It would be considered prospective testing for the purpose of validating the device.
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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 in the context of this device. Ground truth for barrier effectiveness and reusability would be established through laboratory methods (e.g., microbial challenges, physical integrity tests) performed by engineers and technicians, not clinical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies primarily to expert review in diagnostic studies.
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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 is not an AI/software device involving human readers.
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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 device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be established through objective laboratory testing. This would include methods to assess:
- Microbial Barrier Effectiveness: E.g., bacterial challenge tests, aerosol particle penetration tests.
- Physical Integrity and Durability: E.g., visual inspection, tensile strength tests, burst strength tests, and other physical property measurements after repeated sterilization cycles to ensure the filter remains intact and functional.
- Sterilant Penetration: Tests to confirm steam can pass through the filter effectively.
- The "ground truth" for this device would be established through objective laboratory testing. This would include methods to assess:
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI 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).