(451 days)
Sterilier CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylenc Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.
SteriTec CROSS-CHECKS EO process indicators are a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing.
The provided text describes a 510(k) application for a chemical process indicator and includes limited information about performance criteria and study details. Based on the available text, here's an attempt to answer the questions, highlighting what is present and what is missing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Changes color during ethylene oxide processing. | "a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing." |
| Indicates that the item has been processed in Ethylene Oxide. | "They indicate that the item has been processed in Ethylene Oxide." |
| Performs safely and effectively. | "performed in a safe and effective manner" |
| Equivalent to the predicate device (Surgicot 20 EO Gas Indicator). | "performed...equivalently to the Surgicot 20 predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Laboratory tests were performed" but does not give a number of indicators tested.
- Data Provenance: Not explicitly stated, but the tests were performed by "an independent testing laboratory." The location of this laboratory and whether the data is retrospective or prospective is not mentioned.
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. For a chemical indicator, ground truth would likely be established by exposure to EO gas under controlled conditions, not by expert interpretation.
4. Adjudication method for the test set
Not applicable/Not specified. Given the nature of a chemical indicator, "adjudication" in the sense of human interpretation of complex outputs is not relevant. The "ground truth" for whether the indicator changed color would be directly observable.
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
Not applicable. This device is a chemical process indicator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself is a "standalone" chemical indicator that changes color. There is no algorithm or human-in-the-loop interaction described beyond the observation of the color change. The "laboratory tests" inherently represent the standalone performance of the indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device would be whether the indicator was actually exposed to ethylene oxide gas under conditions that should trigger a color change, and conversely, whether it remained unchanged when not exposed. This would be established by controlled laboratory exposure to EO (or lack thereof) rather than expert consensus or pathology.
8. The sample size for the training set
Not applicable. Chemical process indicators typically do not involve "training sets" in the machine learning sense. Their performance is based on chemical reactions.
9. How the ground truth for the training set was established
Not applicable (see point 8).
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).