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ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.

ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 106 Bacillus subtilis spores (ATCC #9372).

The provided document describes the "PROSPORE 2ª SELF CONTAINED BIOLOGICAL VII. INDICATOR" for Ethylene Oxide sterilization. It details the device, its operational principles, and a summary of testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative manner as one might find in a clinical study. Instead, it focuses on demonstrating "stability" and "effectiveness" in comparison to a predicate device. The performance is summarized as meeting these qualitative criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "three separate lots of finished product ProSpore2 vials" were used for shelf-life stability testing. It doesn't specify the exact number of units per lot or the total number of units tested across various experiments (e.g., recovery media efficacy, 48-hr incubation).
• Data Provenance: The data appears to be prospective as it involves the testing of the newly developed ProSpore2® device by the manufacturer (Raven Biological Laboratories, Inc.) for the purpose of regulatory submission. The country of origin for the data is implied to be the United States, where the manufacturer is located and where the FDA regulatory process took place.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not detailed in the provided summary. Biological indicator testing typically relies on standardized laboratory procedures and measurements (e.g., spore enumeration, D-value calculation, growth observation) rather than expert consensus on subjective interpretations. Therefore, the "ground truth" is established by the inherent biological response and observable color change, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not detailed in the provided summary. Given the nature of biological indicator testing, adjudication by multiple human experts is typically not a primary method for determining the success or failure of the indicator itself. The outcome (color change or no color change) is a direct, objective result of spore viability.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging diagnostics or other AI-assisted diagnostic tools where human readers interpret complex data with and without AI assistance. The ProSpore2® is a self-contained biological indicator, and its performance is assessed directly through its biological response and observable color change, not through human interpretation that would be improved by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the ProSpore2® device. The device itself is the "standalone" indicator. There is no AI algorithm being used, nor is there a human-in-the-loop interacting with an algorithm. The performance of the device is assessed by observers noting the color change (or lack thereof) after incubation.

7. Type of Ground Truth Used

The ground truth used is primarily biological response and physical observation. For spore viability, this involves:

• Biological viability: The ability of Bacillus subtilis spores to germinate and grow when not sufficiently sterilized, leading to metabolic activity.
• pH change: The metabolic activity of viable spores produces acidic byproducts, causing a quantifiable pH drop in the growth media.
• Colorimetric change: The pH indicator (bromothymol blue) visibly changes color from green to yellow in response to the pH drop, indicating viable spore growth.

This is a direct, objective measurement of the indicator's function.

8. Sample Size for the Training Set

This information is not applicable/not provided. The ProSpore2® is a physical biological indicator, not an AI model or algorithm that requires a "training set" in the computational sense. The device's design and formulation were developed through traditional biological and chemical engineering, not machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for developing such a device would involve extensive laboratory research, microbiology, and chemical principles to ensure the correct spore type, population, growth media, and indicator system are effectively integrated. This is a scientific and engineering development process, not the establishment of ground truth for a machine learning training set.

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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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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

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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

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.

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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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