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The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:

The proposed Verify® 275F 3 Indicator consist of:

• A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spot.
  The indicator ink spot is located on one end of the strip, adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify" 275F 3 Indicator changes from yellow to blue/purple color when the steam sterilization cvclc is complete.
  The Verify® 275F 3 Indicator can be used to monitor 3 minute 275°F (135°C) prevacuum steam sterilization cycles.

Here's an analysis of the provided text regarding the Verify® 275F 3 Indicator, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for a premarket notification for a Class 6 chemical indicator. It describes the device, its intended use, and states that performance testing was conducted to verify that the device meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating (Class 6) steam indicators. However, the document does not provide specific details about the study methodology or the exact reported performance metrics that would typically be found in a comprehensive clinical or performance study report.

Based on the available information, here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as implied by the standard and intended use):

Important Note: The document states that the device "meets the requirements," but it does not quantitatively report the exact performance (e.g., specific time-temperature parameters at which the color change definitively occurs, the accuracy or precision of this change, or any statistical measures of performance). The acceptance criteria for Class 6 indicators in ANSI/AAMI/ISO 11140-1:2005 are complex, involving stated values (SV) for time at specific temperatures, and the indicator's response needs to be within certain limits of those SVs. These specific values are not provided in this 510(k) summary.

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

The document states: "Performance testing was conducted to verify that the proposed Verify® 275F 3 Indicator meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ST44."

• Sample Size: Not specified. The document does not provide any details about the number of indicators tested.
• Data Provenance: The testing was conducted by STERIS Corporation, presumably at their facilities. The country of origin for the data is not explicitly stated but would likely be the USA, given the company's location (Mentor, OH) and regulatory submission context. The study is prospective in nature, as it involves newly manufactured indicators undergoing controlled testing.

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

Not Applicable. For a chemical indicator, the "ground truth" is typically established by the physical parameters of the resistometer (e.g., temperature, time, steam quality) and the pre-defined, objective color change required by the standard. There is no mention of human expert assessment being used to establish the ground truth for the performance of the indicator itself, beyond potentially observing and verifying the color change against the reference block.

4. Adjudication Method

Not Applicable. As the ground truth is based on the physical parameters of the resistometer and the objective color change, there isn't a need for expert adjudication in the way it would be applied to, for example, image interpretation.

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

Not Applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool for human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

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

Yes, implicitly. The chemical indicator's performance is standalone in the sense that its color change is a physical/chemical reaction to a specific sterilization cycle. The testing described (using a resistometer to ANSI/AAMI ST44) measures the indicator's performance directly and objectively, independent of human interpretation for the primary result. The human element would come in simply observing whether the color change has occurred to confirm a passed cycle.

7. Type of Ground Truth Used

The ground truth used is based on controlled physical parameters and objective chemical reaction. Specifically:

• The resistometer ensures precise control over the steam sterilization conditions (temperature, pressure, time).
• The ANSI/AAMI ISO 11140-1:2005 standard defines the acceptable performance characteristics for Class 6 emulating indicators under these controlled conditions, including the expected color change.
• The "endpoint color" reference block on the indicator itself serves as an objective visual ground truth for comparison.

8. Sample Size for the Training Set

Not Applicable. Chemical indicators are physical devices that react to specific conditions. They do not involve algorithms or machine learning that require a "training set" in the computational sense. The design and formulation of the chemical indicator are developed through R&D, not trained on data.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

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