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Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.

This document describes a 510(k) submission (K082756) for the Raven ProTest - Steam Biological Indicator, which is intended for monitoring steam sterilization cycles. The submission seeks to expand the label claims to include 132°C gravity/flash gravity cycles. The key information is structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Testing was performed on "three separate lots of product manufactured from three different primary spore crops." The exact number of individual biological indicators tested within these lots is not specified.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Raven Biological Laboratories. The data is retrospective in relation to the submission.

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

Not applicable. This device is a biological indicator, and its function is to change color in the presence or absence of viable spores after a sterilization cycle. The "ground truth" is determined by the biological activity of the Geobacillus stearothermophilus spores and the effectiveness of the sterilization process itself, not by human expert opinion interpreting an output.

4. Adjudication Method for the Test Set

Not applicable. The outcome of the biological indicator (color change, turbidity) is a direct biological and chemical reaction, not subject to human adjudication in the context of establishing ground truth for the device's performance. The "ground truth" for each test condition (e.g., sterilization or no sterilization) would be established by physical/chemical parameters of the sterilizer or deliberate under-processing. A "control unit" is used to confirm spore viability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a biological indicator, not an imaging or diagnostic device requiring human interpretation of complex data. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes. The described testing focuses solely on the performance of the biological indicator itself, independent of a human interpreter's direct involvement in its primary function. The indicator's performance (color change, spore recovery, resistance) is intrinsic to the device.

7. The Type of Ground Truth Used

The ground truth is based on:

• Biological Activity: The viability and growth of Geobacillus stearothermophilus spores, indicated by metabolic activity leading to a pH change.
• Chemical Change: The color change of the bromocresol purple indicator from purple to yellow, signifying acid production from spore metabolism.
• Physical Parameters of Sterilization: The conditions of the 132°C gravity displacement and 132°C flash gravity displacement steam sterilization cycles, which are designed to kill microorganisms. A successful cycle should result in no growth, while an unsuccessful one should (ideally) show growth.

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning training sets. This device is a biological indicator, not an AI/ML algorithm that requires a training set. Its "training" is in its design and manufacturing process to consistently meet biological and chemical specifications.

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

Not applicable. (See point 8). The "ground truth" for manufacturing control and device specification adherence would be established through a robust Quality Management System and adherence to relevant standards (e.g., AAMI/ISO 11138-1:2006). For example, spore counts and D-values (decimal reduction time) are verified during the manufacturing of biological indicators.

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Raven ProChem EXT chemical integrator is an integrating chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121℃, 20 minutes; 132℃, 8.5 minutes; 134℃, 7.5 minutes and 135℃, 7 minutes.

ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color. The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ProChem EXT Chemical Integrator, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "3 separate production lots of chemical integrators" were used. The exact number of integrators per lot is not specified.
• Data Provenance: The data was generated through laboratory testing in an "AAMI compliant steam resistometer," indicating a controlled experimental environment. The country of origin and whether it was retrospective or prospective is not explicitly stated, but the nature of the testing suggests it was prospective, laboratory-controlled data.

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

• This information is not provided in the document. The acceptance criteria are based on a standard (ANSI/AAMI ST 60 - 1996), and the device's performance was measured against this standard using instrumental methods (AAMI compliant steam resistometer) rather than expert human assessment for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The performance was assessed against a standard using a resistometer, not through human adjudication or consensus on interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, and its performance is evaluated against scientific standards and instrumental measurements, not by human readers interpreting results in a clinical setting in comparison to AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in a manner relevant to this type of device. The "performance testing" described is essentially standalone. The ProChem EXT Chemical Integrator itself is the "device" being tested in isolation by exposing it to specified sterilization conditions in a resistometer to observe its color change independently. There is no "human-in-the-loop" component in assessing the inherent performance of the chemical indicator against the defined standard.

7. The Type of Ground Truth Used

• The ground truth used is based on defined physical parameters and chemical reactions as standardized by ANSI/AAMI ST 60 - 1996. The "ground truth" for whether the device performed correctly is its color change from green to black when subjected to specific temperature and time combinations in a steam sterilizer, as measured and verified by the AAMI compliant steam resistometer.

8. The Sample Size for the Training Set

• This information is not applicable as the ProChem EXT Chemical Integrator is a physical chemical indicator, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. Its performance is inherent to its chemical composition and design, not learned from data.

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

• This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

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The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 TM , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Raven Pro-PACT Peracetic Acid Culture Test Kit." While it confirms the device's substantial equivalence and outlines its indications for use, it does not contain the detailed acceptance criteria or the study data that would prove the device meets those criteria.

Therefore, I cannot provide the requested information based on the given text.

The document essentially states:

• Device Name: Raven Pro-PACT Peracetic Acid Culture Test Kit
• Intended Use: Testing the efficacy of Steris System1™ liquid chemical sterilization system processing cycles.
• Key Validation Point: "A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit."

To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and study summaries) or a more detailed technical document about the device's validation.

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The Raven Bacterial Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of Chemiclave sterilization cycles at 132°C. A reduced incubation time of 72 hours at 60°C +/- 2°C has been validated for Chemiclave sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Raven Bacterial Spore Strips." It does not contain information about the acceptance criteria and study proving a device meets those criteria in the typical format requested for AI/ML device approval.

Instead, this document is a regulatory approval for a sterilization process indicator, which is a biological indicator used to test the efficacy of sterilization cycles. The "acceptance criteria" here refers to the validation of the spore strip's performance in indicating successful sterilization, rather than performance metrics for an AI algorithm.

Therefore, I cannot provide all the requested information for an AI/ML device study. However, I can extract the relevant information from this document regarding the validation of this specific biological indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria" in this Context:

For a biological indicator like the Raven Bacterial Spore Strips, the "acceptance criteria" are not statistical metrics like sensitivity or specificity in an AI model. Instead, they refer to the conditions under which the device is intended and validated to perform effectively, which typically involves demonstrating that the spores on the strip are killed under proper sterilization and survive if sterilization is inadequate within specific parameters (temperature, time, and incubation conditions). The document confirms that the device has been validated to meet these intended uses and conditions.

Regarding the other requested points (2-9), this document does not contain that level of detail as it pertains to AI/ML device studies.

Here's why and what we can infer:

• 2. Sample size used for the test set and the data provenance: Not applicable in the context of this device. The "test set" would refer to sterilization cycles and spore strips used in rigorous validation studies, but the specific numbers and provenance are not in this FDA letter.
• 3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for biological indicators is typically established by laboratory standards and established microbiological methods for sterility testing.
• 4. Adjudication method: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML diagnostic device with human readers.
• 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a physical biological indicator, not an algorithm. Its "performance" is based on the viability of spores after a challenge.
• 7. The type of ground truth used: For biological indicators, the ground truth is typically the sterility or non-sterility of the challenged item/environment, determined by microbiological culture methods (e.g., absence of growth indicates sterility, presence of growth indicates non-sterility). For the spore strip itself, the ground truth relates to the known resistance of the spores to specific sterilization parameters and their subsequent growth characteristics in a defined medium.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA letter confirms the regulatory clearance of a well-established medical device type (biological indicator) based on its specified intended use and validation using standard microbiological principles, not an AI/ML algorithm requiring the specific study details you've outlined.

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Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.

Here's an analysis of the provided text regarding the ProTest - EO Biological Indicator, structured according to your request:

Acceptance Criteria and Device Performance Study

The document describes the ProTest-EO Biological Indicator, a self-contained unit for monitoring ethylene oxide (EO) sterilization cycles. The study to prove the device meets acceptance criteria involved testing based on AAMI ST59:1999.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Three separate lots of product manufactured from three different primary spore crops were tested." This implies testing was conducted on a sufficient number of product units from each of these distinct lots/spore crops to establish reliability and consistency. The exact number of individual biological indicators tested within each lot is not specified in the provided summary.
• Data Provenance: Not explicitly stated, but given it's for FDA submission, it's presumed to be from the manufacturer (Raven Biological Laboratories) in the United States. The study is prospective in the sense that the testing was performed specifically to validate the claims for this device prior to its market release.

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

• Not Applicable. This type of device relies on a biological response (spore viability/growth) as its "ground truth" rather than expert interpretation of images or clinical data. The "ground truth" for whether sterilization failed or succeeded is determined by the presence or absence of spore growth, indicated by a color change. The AAMI ST59:1999 standard itself dictates the parameters for determining effectiveness.

4. Adjudication Method for the Test Set

• Not Applicable. As described above, the outcome is a direct biological response (color change/turbidity) as per the operational principles, not a subjective interpretation requiring adjudication among experts. The "ground truth" is a direct experimental finding of spore viability.

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

• Not Applicable. This is a biological indicator, not an AI-powered diagnostic device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, this is effectively a standalone performance study. The device itself provides the result (color change or turbidity for growth, or no change for no growth) based on the biological reaction. Human involvement is limited to activating the device, incubating it, and observing the color change, which is a direct, objective read. There's no "algorithm" in the sense of a software-based AI, but the biological indicator system operates autonomously to indicate growth.

7. The Type of Ground Truth Used

• Experimental/Biological Ground Truth: The ground truth is the viability of the Bacillus atrophaeus spores after exposure to an ethylene oxide sterilization cycle.
  • Negative Result (Sterilization achieved): No viable spores remain, thus no growth and no color change within 48 hours.
  • Positive Result (Sterilization failed): Viable spores remain, leading to germination, metabolic activity, and a color change from green to yellow due to pH reduction, within 48 hours.
  • A control unit (unprocessed) is run concurrently to ensure the spores are viable and the culture medium supports growth, confirming the validity of the test.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device that requires a "training set." The performance is based on the inherent biological properties of the spores and media, validated through direct experimental testing.

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

• Not Applicable. No training set was used. The ground truth for the performance study (resistance, spore population, recovery, incubation time) was established through controlled laboratory experiments, often comparing against established reference methods or standards (like AAMI ST59:1999) using known sterilization parameters and calibrated equipment to assess spore viability and growth.

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Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

This document describes the Raven ProTest - Steam Biological Indicator, a self-contained biological indicator designed to monitor the efficacy of steam sterilization cycles.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance is described in the context of validating its labeled claims and characteristics during testing. The primary performance goal is to demonstrate effective monitoring of steam sterilization cycles.

Study Information:

1. Sample size used for the test set and data provenance:

   • Sample Size: "Three separate lots of product manufactured from three different primary spore crops" were tested. While the exact number of individual biological indicators within these lots isn't specified, it indicates an evaluation across different production batches.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing was "performed in accordance with AAMI ST59:1999," which is a US standard. The study seems to be internal validation by the manufacturer, Raven Biological Laboratories. The study is retrospective in the sense that it evaluates the manufactured product against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of biological indicator study does not typically involve human experts establishing ground truth in the way a diagnostic imaging study would. The ground truth for biological indicators is established by the known conditions of the steam sterilization cycle (e.g., fully successful sterilization vs. partial/failed sterilization conditions). The "ground truth" of whether spores survived or not is determined by their biological response (growth/no growth) and color change.

3. Adjudication method for the test set:

   • Not applicable as the "ground truth" is determined by the biological reaction of the spores themselves and their nutrient media, rather than expert interpretation of complex data. The "adjudication" is essentially the observation of a color change or turbidity.

4. 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:

   • Not applicable. This device is a biological indicator, not an AI-powered diagnostic tool. There are no "human readers" interpreting images or complex data in the sense of an MRMC study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its biological and chemical components.

6. The type of ground truth used:

   • Biological Response: The ground truth is established by the biological viability of the Geobacillus stearothermophilus spores under different sterilization conditions. A successful sterilization cycle should render the spores non-viable, leading to no growth and no color change in the media. An unsuccessful cycle should leave viable spores, leading to growth (turbidity) and a color change (purple to yellow). This is a direct biological and chemical outcome.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of device.

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The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization when the Spore Strip (either the single species G. stearothermophilus or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple

This document is a 510(k) clearance letter for the Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple. It primarily deals with the regulatory approval of a sterilization process indicator and does not contain detailed information about acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML device evaluations. Therefore, I cannot extract the requested information from the provided text.

The document confirms that:

• Device Name: Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple
• Indications For Use: Intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization.
• Regulation Number: 880.2800 (Sterilization Process Indicator)
• Regulatory Class: II
• Product Code: FRC

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The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

Not Found

Because the provided text is a regulatory 510(k) clearance letter from the FDA, it outlines the regulatory approval for a medical device but does not contain the detailed scientific study information requested. The letter confirms substantial equivalence to a predicate device and provides general information about regulatory compliance. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information on MRMC studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request with the provided input. This document serves as a regulatory approval notice, not a scientific study report.

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The Raven Bacterial Spore Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.

Here's an analysis of the provided text to extract the acceptance criteria and details about the study.

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: "three lots each of newly manufactured spore strips, spore strips nearing expiry, newly manufactured Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP) and MTSB w/ BCP nearing expiry."
     • This means 3 lots of new spore strips, 3 lots of expiring spore strips, 3 lots of new media, and 3 lots of expiring media.
     • The exact number of individual spore strips or media vials tested within these lots is not specified.
   • Data Provenance: Not explicitly stated, but given the submitter is Raven Biological Laboratories, Inc. in Omaha, NE, and the document is for FDA submission, it's highly probable the testing was conducted in the USA by the manufacturer or a contracted lab. The study is retrospective in the sense that the testing has already been completed to support the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study does not involve human expert interpretation of results, but rather a direct biological outcome (bacterial growth/no growth, indicated by color change/turbidity). The determination of growth is objective.

3. Adjudication method for the test set: Not applicable. The "ground truth" (presence or absence of bacterial growth) is determined directly by objective observation (color change, turbidity) of incubated media. There's no subjective interpretation requiring adjudication among human readers.

4. 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: Not applicable. This is not a study involving human readers or AI. It's a performance validation of a biological indicator.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biological indicator, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is the biological outcome of bacterial growth or inhibition, as evidenced by a color change (purple to yellow) and/or turbidity in the growth media after incubation. This result directly indicates whether sterilization was successful or not.

7. The sample size for the training set: Not applicable. This is a biological indicator validation, not a machine learning model, so there is no training set in the conventional sense.

8. How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the validation study (test set) was established by observing bacterial growth/no growth.

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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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