(23 days)
The SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. SPOR-TEST PA Biological Indicators are qualified using Getinge Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.
The SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris System 1 liquid chemical sterilization process, with Steris 20 sterilant. The product contains chromatography strips that are inoculated with Geobacillus stearothermophilus spores at a nominal population of 10^6 per strip. Sterile tubes of Getinge Media (modified soybean casein digest broth) and a transfer loop are also included. The SPOR-TEST PA Biological Indicator Kit is used in the same manner as the Steris® Process Biological Indicator Kit.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in a structured manner that allows direct extraction into the requested table format. The document is a 510(k) summary for a biological indicator kit, focusing on its equivalence to a predicate device rather than detailed performance study results against specific criteria.
However, I can extract the closest information available regarding performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Survive at 41 seconds (at 1,000 ppm peracetic acid, 50°C) | The SPOR-TEST PA Biological Indicator will survive at 41 seconds. |
| Killed at 6 minutes (at 1,000 ppm peracetic acid, 50°C) | The SPOR-TEST PA Biological Indicator will be killed at 6 minutes. |
| Readout time | Greater than 97% assurance for a 48 hour readout. (The change from 72 hours to 48 hours was the only modification from the predicate device). |
2. Sample size used for the test set and the data provenance:
- Sample size: "Samples from a minimum of 3 different lots of SPOR-TEST PA were tested." The exact number of individual indicators tested per lot is not specified.
- Data provenance: Not explicitly stated, but given it's a submission to the FDA by "Getinge USA, Inc." located in Rochester, NY, it is presumed to be US-based. The study appears to be prospective for the purpose of demonstrating the device's performance qualities, as it describes actively testing samples of the new device.
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 in the document. The "ground truth" for a biological indicator typically involves observing growth or no growth of the spores under controlled conditions, which doesn't usually involve human experts in the same way, for example, a medical imaging diagnosis does. The determination of "survive" or "killed" is a direct biological outcome.
4. Adjudication method for the test set:
- This information is not provided. As mentioned above, the assessment of biological indicators (growth/no growth) is generally a direct observation rather than requiring expert adjudication.
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:
- An MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance. The SPOR-TEST PA Biological Indicator Kit is a direct biological indicator, not a diagnostic imaging or AI-assisted interpretation device. The document mentions "human readers improve with AI vs without AI assistance" which is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance study was not done in the context of an algorithm. This device is a biological indicator; its performance is the direct result of biological interaction (spore survival/kill) with a sterilant, not an algorithm.
7. The type of ground truth used:
- The ground truth is based on the biological outcome of the Geobacillus stearothermophilus spores – specifically, whether they survive or are killed under controlled peracetic acid sterilization conditions. This is a direct measure of efficacy.
8. The sample size for the training set:
- This information is not applicable and therefore not provided. The device is a biological indicator, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as 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).