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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Here's an analysis of the provided FDA 510(k) clearance letter, focusing on the acceptance criteria and the study proving the device meets them:

The VERIFY STEAM Integrating Indicator (K243876) is a chemical indicator designed to monitor steam sterilization cycles. It is intended to be placed within containment devices (packs, pouches, etc.) during sterilization to independently verify that critical parameters have been met. The device is considered to "pass" if a dark bar on the indicator enters the "ACCEPT (OK)" window.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical testing performed to evaluate the performance of the VERIFY STEAM Integrating Indicator and demonstrate its substantial equivalence to a predicate device (K213412).

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

• The document does not specify the exact sample sizes (number of indicators) used for each individual test (Stated Value, Simulated Use, Stability, Comparison with Biological Indicator).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission for a medical device, it is highly likely that these were prospective, laboratory-based studies conducted by the manufacturer (STERIS Corporation, Franklin Park, IL, USA) to evaluate the device's performance under controlled conditions.

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

• This device is a chemical indicator that produces a visual change (dark bar entering an "ACCEPT (OK)" window) based on exposure to sterilization parameters. The "ground truth" for these tests is established by the controlled sterilization cycle conditions (temperature, time, presence of steam) and the objective physical change of the indicator, rather than subjective expert interpretation.
• Therefore, no human experts were used to establish the ground truth for the test set in the way radiologists or pathologists would interpret an image. The performance is assessed against defined physical and chemical criteria.

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

• As the "ground truth" is determined by objective physical and chemical changes under controlled conditions, and the outcome (pass/fail) is a direct observation of the indicator's state, no adjudication method involving human experts was necessary for the test set.

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 type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VERIFY STEAM Integrating Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its primary function is to react chemically, not to be "read" in a complex interpretive sense by multiple human readers.

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

• This question is not applicable in the context of a chemical indicator. The device is entirely standalone in its function – it reacts chemically without any human intervention or an algorithm. Its "performance" is its physical color change, which is then observed by a human. There is no separate "algorithm" to evaluate.

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

• The ground truth for these tests is based on objective physical and chemical properties and predefined standards. Specifically:
  • Controlled Sterilization Parameters: The cycles are run at precisely defined temperatures and times, and the presence of steam is controlled. The "truth" is whether these parameters were met or not.
  • ANSI/AAMI/ISO 11140-1:2014: This international standard defines the performance requirements for chemical indicators, providing the objective benchmarks against which the device is evaluated.
  • Biological Indicator Inactivation: For comparison testing, the inactivation of a biological indicator (a highly resistant microorganism) serves as an objective "gold standard" for sterilization efficacy.

7. The sample size for the training set:

• The document does not mention a "training set" in the context of device development. This concept is typically associated with machine learning or AI models. For a chemical indicator, the "development" involves chemical formulation, material science, and engineering to achieve the desired reaction kinetics and visual endpoint. There isn't a "training set" in the computational sense.

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

• As there is no "training set" in the conventional sense for this type of device, this question is not applicable. The development of such an indicator would involve extensive research and development in chemistry and material science, where performance is iteratively optimized against the physical/chemical principles of sterilization and the requirements of relevant standards.

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