(86 days)
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. The device is a Bacillus stearothermophilus in a recovery medium of Tryptic Soy Broth with Bromocresol purple, a pH indicator.
Here's an analysis of the provided information, structured according to your request. However, it's immediately apparent that this document describes a biological indicator, which is a method for validating sterilization, not a digital medical device or AI system in the conventional sense. Therefore, many of the requested sections (e.g., MRMC studies, expert consensus for ground truth, training sets) are not applicable. I will indicate where this is the case.
Acceptance Criteria and Study for ProSpore Self-contained Biological Indicator
This document describes the ProSpore® self-contained biological indicator, a device used to determine the efficiency of steam sterilization cycles. The "acceptance criteria" in this context refer to the performance specifications the biological indicator itself must meet, rather than the performance of a diagnostic algorithm. The "study" refers to non-clinical tests performed to validate these specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specifications) | Reported Device Performance (Confirmed by Nonclinical Tests) |
|---|---|
| Microorganism: Bacillus stearothermophilus (ATCC # 7953) | Confirmed |
| Population: 1.0 x 10⁵ - 4.0 x 10⁵ cfu/unit | Confirmed |
| Resistance Characteristics (for saturated steam at 121ºC): | |
| - D-value: (determined using Spearman-Karber method) | Confirmed (no specific value given in summary, but validated) |
| - Survival time: (USP XXII, p. 204) = [min] labeled D-value x (log10 labeled spore count per carrier - 2) | Confirmed (no specific value given in summary, but validated) |
| - Kill time: (USP XXII, p. 204) = [max] labeled D-value x (log10 labeled spore count per carrier + 4) | Confirmed (no specific value given in summary, but validated) |
| Incubation period: 7 days | Confirmed (labeled incubation period validated) |
| Ampule: USP type 1. 4-ml flame-seal flint glass ampule | Confirmed |
| Culture/recovery medium: Trypticase® Soy Broth with Bromocresol Purple, adjusted to pH 7.0 | Confirmed |
| Stability: Population and D-value stability after one year | Confirmed |
| Recovery of damaged spores | Confirmed |
| Effect of pH indicator on recovery of injured spores | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "tested samples" in the nonclinical validation studies. However, it does not specify the sample size for these tests. The data provenance is internal laboratory testing performed by Raven Biological Laboratories, Inc. These were non-clinical, laboratory-based studies rather than human clinical studies, and are inherently prospective in their design (i.e., experiments are set up to test specific parameters).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. For this biological indicator, the "ground truth" concerning its specifications (e.g., spore count, D-value, stability) is established through standardized microbiological and chemical testing methods outlined by USP (United States Pharmacopeia) and internal laboratory protocols, not by expert interpretation in the way one would assess medical images or clinical outcomes. The personnel performing these tests would be microbiologists and laboratory technicians, likely under the supervision of a production microbiologist (as Russ Nyberg is listed).
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts when establishing ground truth for subjective or complex data (e.g., medical imaging. For the quantitative measurements and performance characteristics of a biological indicator, the results are typically determined by objective lab measurements as per validated protocols, not expert consensus.
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
This section is not applicable. The ProSpore® is a biological indicator, not an AI system. It does not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The ProSpore® is a physical biological indicator, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth for the performance characteristics of the ProSpore® biological indicator is established through standardized laboratory testing and measurements based on established microbiological and pharmacopeial methods (e.g., USP XXII). This involves direct quantification of parameters like spore population, D-value calculation, and observation of growth/color change under specific controlled conditions. There is no "expert consensus" or "pathology" in the medical sense involved here, but rather adherence to scientifically validated test procedures.
8. The Sample Size for the Training Set
This section is not applicable. The ProSpore® is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process in that context.
§ 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).