(33 days)
ProSpore® is a biological steritization process indicator for steam sterilization at 121°C is a device intended for use by a health care provider to accompany products being sterilized through a steam sterilization procedure and to monitor adequacy of sterilization.
ProSpore is a self-contained biological indicator used for determining the efficacy of a 121°C sterilization cycle. The device is a hermetically sealed glass ampoule containing Bacillus stearothermophilus ATCC#7953 bacterial spores in a recovery medium of Tryptic Soy Broth with Bromocresol Purple pH indicator.
The acceptance criteria and study proving the device meets these criteria for the ProSpore Self-contained Biological Indicator are detailed below, based on the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability of resistance characteristics and spore population (presumably over time) | Demonstrated for three separate lots. |
| Recovery of low numbers of injured spores | Demonstrated. |
| Effect of pH indicator on recovery of spores | Demonstrated (implying no detrimental effect or an acceptable interaction). |
| Reduced incubation period of 48 hours | The device demonstrates evidence of growth by color change and/or turbidity within 48 hours for effective monitoring of sterilization, provided signs of growth are present in the control ampoule. This implies the 48-hour period is sufficient for detection. |
| Overall effectiveness in monitoring routine steam sterilization cycles | Demonstrated. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The text states, "Testing was performed to validate the labeled claims and performance characteristics for Prospore. These included using three separate lots to show stability of resistance characteristics and spore population..." This indicates that a minimum of three production lots were used for testing, although the exact number of individual indicators within each lot or across all tests is not specified in the provided document.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Raven Biological Laboratories, Inc. The document does not specify country of origin or whether the study was retrospective or prospective, though it implicitly describes prospective testing for device validation.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the document. The nature of the device (biological indicator for sterilization) suggests that ground truth would be established by direct observation of bacterial growth and/or color change, rather than interpretation by human experts in the traditional sense of diagnostic imaging. The "growth by color change and/or turbidity" within 48 hours is the direct measure.
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Adjudication Method for the Test Set:
- This information is not provided. Given the objective nature of detecting bacterial growth (color change/turbidity), a formal expert adjudication method (like 2+1, 3+1) is typically not applicable. The assessment would likely involve direct observation against a control.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The device is a biological indicator designed to provide a direct readout (color change/turbidity) of sterilization efficacy, not an imaging or diagnostic tool requiring human interpretation relative to AI. Therefore, the concept of human readers improving with AI assistance does not apply here.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in effect, a standalone performance was done. The ProSpore device is a standalone system. It functions as an "algorithm only" in the sense that its output (color change or turbidity) is an inherent, direct chemical/biological reaction of the indicator itself, without human interpretation as part of its core performance measurement. Its performance is measured directly by its ability to register growth if sterilization is incomplete.
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The Type of Ground Truth Used:
- The ground truth used is biological activity/outcomes data. Specifically, it is the actual growth or non-growth of Bacillus stearothermophilus spores and the resulting color change (from purple to yellow) or turbidity in the recovery medium when subjected to specific sterilization conditions (or lack thereof for controls). This directly indicates the success or failure of sterilization.
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The Sample Size for the Training Set:
- This information is not provided. The document describes validation testing, not a machine learning context. Therefore, the concept of a "training set" for an algorithm is not applicable to this biological indicator.
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How the Ground Truth for the Training Set was Established:
- As the device is a biological indicator and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it does not apply in the traditional sense. The device's "training" is its inherent biological and chemical design, optimized through laboratory development to respond to specific sterilization conditions.
§ 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).