(35 days)
ProSporeII® is a biological sterilization 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.
ProSpore2 is a self-contained biological indicator used for determining the efficacy of a 121°C steam sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside the tube is a 1ml glass ampoule of growth media consisting of Tryptic Sov Broth and a pH indicator of Bromocresol Purple. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the ProSpore2 Self-contained Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail thresholds. However, based on the description of the testing and the conclusion of substantial equivalence, the implicit acceptance criteria relate to the stability and effectiveness of the device compared to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Population Stability over 18-month shelf life | Demonstrated. |
| D-value stability over 18-month shelf life | Demonstrated (tested with three separate lots). |
| Reduced incubation time validation (48-hour) | Validated (based on testing results). |
| Recovery media stability in recovering low numbers of injured spores over 18-month shelf life | Demonstrated. |
| Stability of color change when growth occurred over 18-month shelf life | Demonstrated. |
| Overall effectiveness in monitoring routine steam sterilization cycles | Demonstrated. |
| Substantial equivalence in composition and function to predicate device (ProofPlus™) | Concluded. The devices are similar in: |
- Intended use (monitoring 121°C steam sterilization)
- Bacterial spore strain (B. stearothermophilus)
- Spore carrier (paper disc)
- Housing (plastic vial and cap)
- Recovery media ampoule (sealed glass)
- pH indicator for growth detection (purple to yellow)
- Activation method (crushing glass ampoule)
- Chemical indicator on label for processed/unprocessed distinction. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document states "three separate lots of finished product Prospore2 units" were tested for Population Stability and D-value stability. It doesn't specify the exact number of units per lot, but implies multiple units within each lot would have been tested across the 18-month shelf life.
- Data Provenance: The data is presented as originating from Raven Biological Laboratories, Inc., the manufacturer of the device. It is prospective data, generated from testing the ProSpore2 device specifically for its shelf-life and performance characteristics. The country of origin is not explicitly stated for the testing location, but the company is based in Omaha, Nebraska, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in the traditional sense (e.g., review of medical images). Instead, the "ground truth" for a biological indicator is the objective outcome of a controlled sterilization process and the subsequent growth or non-growth of the bacterial spores. The testing itself, conducted by the manufacturer's microbiologist and likely other qualified personnel within the company, serves as the establishment of this "truth" based on microbiological principles and FDA guidelines.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication" in this context is the objective observation of bacterial growth (color change) or lack thereof after a defined sterilization and incubation period. It's a binary outcome based on scientific observation, not a subjective interpretation requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation heavily influences the outcome. For a biological indicator, the performance is a direct result of the biological response to the sterilization process and the growth media.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively standalone performance, as it evaluates the device's intrinsic biological and chemical function without human-in-the-loop diagnostic interpretations. The device's color change is an automated visual indicator of growth, not requiring complex human judgment for its primary function.
7. The Type of Ground Truth Used
The ground truth used is based on microbiological principles and observable outcomes:
- For resistance characteristics (D-value), the ground truth is established by exposing the spores to controlled sterilization conditions and observing the kill rate.
- For population stability, the ground truth is the actual count of viable spores.
- For recovery media performance, the ground truth is the successful cultivation of viable spores, especially injured ones.
- For the overall effectiveness, the ground truth is the unambiguous indication of successful or failed sterilization based on spore viability (no growth vs. growth).
8. The Sample Size for the Training Set
There is no "training set" in the context of an AI/ML algorithm for this device. Biological indicators do not employ AI or machine learning. Their function is based on a direct biological response.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).