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The Verify® V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 1 Low Temperature Sterilization System.

The Verify V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the Amsco® V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer. The user places the packaged Verify V24 SCBI into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media. The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid. The modified Verify V24 Self-Contained Biological Indicator is identical in design to the original K073244 device with exception of the media formulation. It is identical with respect to performance specifications with exception of the incubation time.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Verify® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual test (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability). It reports results in a summary format ("Pass").

The data provenance is not explicitly stated in terms of country of origin. Given the submission is to the US FDA, it is highly likely the studies were conducted in the US or under US regulatory standards. The studies are non-clinical tests conducted to confirm the performance of the modified culture media, implying they are prospective experimental studies designed to evaluate the modified device.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical or diagnostic evaluations. The testing described focuses on the intrinsic performance of the biological indicator (e.g., microbial growth, color change, stability) under controlled laboratory conditions, rather than interpreting complex human-generated data. Therefore, the concept of qualified experts establishing ground truth as in a diagnostic imaging study is not applicable here.

4. Adjudication Method for the Test Set:

No adjudication method is described. The tests are laboratory-based and likely involve objective measurements (e.g., observation of color change, presence/absence of growth, incubation time).

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

No MRMC study was done, as this is a biological indicator designed to provide a direct readout of sterilization efficacy, not to be interpreted by human readers for diagnostic purposes where human variability would be a factor.

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

Yes, a standalone performance evaluation was conducted. The described tests (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability) are all objective, laboratory-based assessments of the biological indicator's performance without human interpretation or intervention in the result generation process. The device itself changes color or fails to change color as its "output," which is then directly observed.

7. Type of Ground Truth Used:

The ground truth for these tests is based on controlled experimental conditions and objective biological/chemical outcomes. For example:

• Sterility: Absence of microbial growth in uninoculated controls.
• Viability/Growth: Presence of microbial growth in inoculated controls.
• Incubation Time: Observed time to positive growth.
• Media Stability: Maintenance of expected performance over time.
  These are not based on expert consensus, pathology, or outcomes data in a clinical sense, but rather on established microbiological and chemical principles.

8. Sample Size for the Training Set:

The document does not mention a "training set" as this device does not utilize machine learning or AI that would require such a dataset. The biological indicator's function is based on a direct biological response, not a learned pattern.

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

Not applicable, as there is no training set for this type of device.

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The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.

The Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes is used by healthcare providers to monitor the Amsco V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer. The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media. The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.

The provided text describes the STERIS Verify® Self-Contained Biological Indicator (SCBI) for Vaporized VH2O2 Sterilization Processes. It outlines various nonclinical tests performed to demonstrate safety and substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria values (e.g., minimum population reduction thresholds, specific D-values, or sterility assurance levels) or detailed study results that explicitly prove the device meets numerical acceptance criteria in a comparative table for each characteristic.

Instead, the document primarily lists a series of nonclinical tests and their qualitative "Pass" results, indicating the device performed within expectations or specifications for each test. It doesn't present a formalized table of acceptance criteria vs. device performance with quantitative metrics.

Therefore, many of the requested elements for a detailed study description are not available in the provided text. I will answer based on the information that is present.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

As noted, the document doesn't provide a table with quantitative acceptance criteria and their corresponding reported device performance values. It lists tests and their qualitative "Pass" results.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each of the nonclinical tests listed. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for a biological indicator would typically be determined by microbiological assays and physical/chemical tests, rather than expert interpretation in the same way as, for example, medical images.

4. Adjudication method for the test set

This information is not applicable and not provided in the document for the type of nonclinical tests described for a biological indicator. Adjudication methods like "2+1" typically apply to diagnostic studies involving human readers.

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 is not applicable to the device described. The device is a biological indicator, a consumable product used to monitor sterilization processes, not an AI-assisted diagnostic tool that would involve human readers.

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

This is not applicable to the device described. The device is a biological indicator, not an algorithm. Its performance is evaluated through its biological response to sterilization conditions.

7. The type of ground truth used

For the biological indicator, the "ground truth" for assessing its performance is based on established microbiological principles, such as:

• Microbiological viability assays: Determining the initial population of spores.
• Resistance profiling: Measuring the D-value (decimal reduction time) or Z-value (temperature coefficient) of the Geobacillus stearothermophilus spores against the sterilant.
• Growth/no-growth observations: Observing the physical change of the media (color change, turbidity) after incubation to indicate the survival or inactivation of spores.
• Sterility testing: For media sterility and package integrity.

The document implicitly refers to these types of ground truths through tests like "Viable Population Assay," "Resistance," and "Controls (Viability and Media Sterility Demonstrated)."

8. The sample size for the training set

This information is not applicable to the nonclinical studies of a biological indicator and is not provided. There is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for an algorithm.

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The Verify® Self-Contained Biological Indicator may be used for installation testing and routine monitoring of the following steam sterilization cycle:

• 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items

The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.

This is a 510(k) summary for a biological indicator and not an AI/ML device per se. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample sizes for training/test sets) are not applicable or cannot be extracted from the provided text. The document focuses on performance testing to expand the indications for use of the biological indicator.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing was conducted," implying a controlled study, but details are not given.

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

• Number of Experts: Not applicable/specified. For a biological indicator, the "ground truth" is determined by whether the indicator correctly registers sterilization or growth, which is a direct biological outcome, not an expert interpretation.
• Qualifications: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The performance of a biological indicator is typically assessed through direct observation of growth or lack thereof in the culture medium, not through expert adjudication in the manner of diagnostic image interpretation.

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

• MRMC Study: Not applicable. This is a biological indicator, not an AI/ML diagnostic device involving human readers.

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

• Standalone Performance: While the "device" (biological indicator) operates independently to indicate sterilization effectiveness, it's not an "algorithm" in the typical sense of AI/ML. Its performance is inherent in its biological response. The study was essentially a standalone performance validation for a specific sterilization cycle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for a biological indicator's performance is typically established by:
  • Microbiological viability: Determining the survival or inactivation of the inoculated Geobacillus stearothermophilus and/or Bacillus atrophaeus spores after exposure to sterilization conditions.
  • Sterilization Cycle Parameters: The efficacy of the sterilization cycle itself, under controlled conditions.
    The document states, "Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle," implying direct biological/physical validation against established sterilization efficacy.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.

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