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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.

• 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.

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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.

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