(172 days)
ProSporeII® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.
ProSpore II is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).
The provided text describes a self-contained biological indicator, ProSpore II, and its equivalence to a predicate device, ProofPlus, for monitoring 121°C steam sterilization cycles. However, the document does not contain a study that presents specific acceptance criteria and reported device performance in a format that can be extracted into the requested table.
Therefore, I cannot provide a direct answer to your request in the specified format. The document focuses on demonstrating substantial equivalence through descriptions of similarity in composition and function, and general statements about stability testing, rather than a detailed performance study with quantifiable acceptance criteria and results.
Here's a breakdown of what is and isn't available in the text:
Not Available in the Text:
- A table of acceptance criteria and reported device performance: The document does not define specific quantitative acceptance criteria (e.g., "D-value must be X ± Y minutes") nor does it provide the exact reported performance values against such criteria. It states that "the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness... has been demonstrated," but without specific numbers or benchmarks.
- Sample size used for the test set and data provenance: No specific sample size for a "test set" (implying a performance evaluation against a gold standard) is mentioned. The testing described focuses on "Population Stability over an 18 month self-life" with "three separate lots of finished product ProSpore II ampules," but this isn't a performance test set in the traditional sense of evaluating efficacy against a specific outcome.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as the "ground truth" for a biological indicator is typically the documented D-value of the spore and its response to sterilization, not an expert consensus on interpreting an image or outcome.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human interpretation or reading in the same way as an imaging diagnostic device. Its output is a color change.
- Standalone performance study (algorithm only): Not applicable, as this is a physical biological indicator, not a software algorithm.
- Type of ground truth used: For stability testing, the ground truth would be the known resistance characteristics of the Bacillus stearothermophilus spores and their expected survival/kill rates under various sterilization conditions, measured through standard microbiological methods (e.g., spore enumeration, D-value determination). The document mentions "D-value stability."
- Sample size for the training set: Not applicable, as this is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
What is mentioned that is relevant, but not in the requested format:
- Device name: ProSpore II® self-contained biological indicator
- Intended Use: Determining the efficiency of a 121°C steam sterilization cycle.
- Predicate Device: ProofPlus™ (AMSCO), K915275
- Testing Information:
- Focus: Population Stability over an 18-month self-life.
- Included: D-value stability and Population stability.
- Lots tested: Three separate lots of finished product ProSpore II ampules.
- Additional testing: Recovery media tested for stability in recovering "low numbers" of "injured spores" over 18 months, and stability of color change when growth occurred.
- Outcome Summary: "For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated."
To answer your request, a different type of document, such as a detailed test report or a clinical study protocol, would be needed. This document serves to establish substantial equivalence for regulatory submission rather than providing specific performance metrics against defined acceptance criteria.
§ 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).