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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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