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The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:

• 270°F (132°C), 3 min. flash gravity steam sterilization .
• 270°F (132°C), 10 min. flash gravity steam sterilization .

The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash steam sterilization cycles.

Here's a breakdown of the acceptance criteria and study information for the Albert Browne Ltd. Verify Gravity Flash Integrator, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The 10 min. indicator ink's performance was not re-evaluated as it was identical to the predicate device's ink and was covered by previous 510(k) submissions (K051101 and K002937).

Study Information

Here's the detailed information about the study as requested:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size for the test set.
   • The document does not explicitly state the country of origin of the test data (though the sponsor is UK-based) nor whether it was retrospective or prospective. It refers to "simulated use testing," which implies prospective testing in a controlled environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not provided in the document. For chemical indicators, the ground truth is typically assessed by objective color change against a reference, rather than expert interpretation in the same way a medical image would be.

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

   • This information is not provided in the document. Given the objective nature of a chemical indicator color change, formal adjudication methods like 2+1/3+1 are less applicable than for subjective interpretations.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.

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

   • This device is a standalone chemical indicator. Its performance is evaluated intrinsically based on its color-change properties when exposed to specific sterilization conditions. There is no "algorithm only" performance separate from the physical indicator itself. The "testing for the 3 min. indicator ink was repeated" and "simulated use testing" represent this standalone performance evaluation.

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

   • The ground truth for this device is based on objective physical/chemical criteria related to sterilization effectiveness. Specifically, the indicator must meet the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996. This standard likely specifies the precise chemical exposure conditions required to elicit the expected color change. "Simulated use testing" would involve controlled sterilization cycles known to achieve (or not achieve) specified sterilization parameters.

7. The sample size for the training set:

   • This device does not involve a "training set" in the context of machine learning or AI. It's a chemical indicator, and its performance is based on its physical/chemical properties.

8. 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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