(245 days)
SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.
Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.
The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
The provided text is a 510(k) Summary of Safety and Effectiveness for the SPSmedical SporView® Steam Self-Contained Biological Indicator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values in a quantitative manner. Instead, it states that "All test results met the defined acceptance criteria."
However, we can infer the types of criteria based on the tests conducted:
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Resistance | Met acceptance criteria |
| Spore population | Met acceptance criteria |
| Media recovery in extended steam sterilization cycles | Met acceptance criteria |
| Effects of holding time | Met acceptance criteria |
| Reduced incubation period | Met acceptance criteria |
| Stability of the color change | Met acceptance criteria |
| Media Evaporation | Met acceptance criteria |
| Survival Response Time | Met acceptance criteria |
| Effects of carrier and package materials | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Multiple lots of indicators were tested for" the various performance characteristics. However, it does not specify the exact sample size for the test set or the number of indicators from each lot.
The data provenance is retrospective in the sense that the testing was performed before the 510(k) submission. The country of origin of the data is not explicitly stated, but given the submitter is "SPSmedical Supply Corp." with an address in Rush, NY, U.S.A., it is highly probable the testing was conducted within the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (biological indicator for sterilization processes) does not typically involve human experts establishing "ground truth" in the way, for example, a diagnostic image analysis AI would. The "ground truth" in this context is based on established microbiological and sterilization testing standards and protocols. Therefore, the concept of and number of "experts" and their qualifications for establishing ground truth is not applicable in the same way as it would be for a medical AI device. The ground truth is determined by the results of the microbiological assays and physical integrity tests themselves, evaluated against pre-defined scientific criteria.
4. Adjudication Method for the Test Set
As the "ground truth" is established through scientific testing and adherence to predefined protocols rather than expert consensus, an adjudication method is not applicable in the traditional sense for this type of device. The results are objectively measured and compared against established scientific and regulatory standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance
A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable to this device. This is a biological indicator, not an AI-powered diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done
This is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its physical and biological properties.
7. The Type of Ground Truth Used
The ground truth used for this device is based on microbiological and physical testing standards and protocols. Specifically:
- Viable spore count (for spore population).
- Sterility or growth of the inoculated organism after exposure to specific sterilization conditions and subsequent incubation (for resistance, media recovery, survival response time).
- Visual observation of color change for pH indicator and physical integrity (for stability of color change, media evaporation, effects of carrier/package materials, effects of holding time).
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" in the context of biological indicators refers to the development and refinement of the manufacturing process and formulation, not data-driven model training.
9. How the Ground Truth for the Training Set was Established
This 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).