(170 days)
The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992.
The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.
The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.
Here's an analysis of the provided text, extracting the requested information about the device's acceptance criteria and studies:
Acceptance Criteria and Study for Propper BI-O.K. EO Gas Biological Test-Pak
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance characteristics similar to existing devices for monitoring ethylene oxide sterilization. | Tested in-house in a Joslyn BIER vessel under controlled conditions (60% RH, 600 mg/L ethylene oxide, 54.4°C). The results obtained are similar to those reported for similar devices. |
| Suitable for its intended use as a disposable device for biological monitoring of ethylene oxide sterilizers in health care facilities. | Based upon indications for use, construction, and performance, deemed "suitable for its intended use" and "substantially equivalent" to established devices like the standard AAMI pack and commercially available test packs from 3M and ATI. Performance was verified versus the standard AAMI pack under specified conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Performance studies" were done "in-house." This indicates the data was retrospective and likely originated from the manufacturer's own testing facility. Specific country of origin is not explicitly stated beyond "in-house," but given the manufacturer's address in Long Island City, New York, the data likely originates from the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Performance studies" section describes in-house testing in a BIER vessel as the basis for performance evaluation.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Performance was evaluated through direct testing in a controlled environment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biological indicator for a sterilization process, not an imaging device or diagnostic tool that typically involves human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Performance studies" describe the device being tested "in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions." This indicates algorithm-only performance testing as the device functions independently of human interpretation in its initial role.
7. Type of Ground Truth Used
The ground truth used was direct experimental outcome (sterilization efficacy in a controlled environment). The device's performance was compared to "similar devices" and "the standard AAMI pack," implying a benchmark based on established scientific principles and industry standards for biological indicators.
8. Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI component. The device is a biological indicator, which operates on a deterministic biological reaction, not a learned algorithm.
9. How Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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).