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Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length.

The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam.

The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. The a -glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure.

The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator and 3M™ Attest™ 490 Auto-reader are designed to monitor steam sterilization cycles. The study provided assesses the performance of both components against established standards and FDA guidance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: "Multiple lots" of 3M™ Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated. Specific numbers are not provided for each test, but the product's performance refers to adherence to international and US standards for biological indicators.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, the testing was conducted in accordance with FDA guidance and international standards (ANSI/AAMI/ISO, USP), implying a controlled laboratory setting for these performance tests.

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 biological indicators is typically established through direct microbiological analysis (e.g., confirming spore viability and count, measuring D-values). Expert consensus in the human interpretation sense (like in image diagnostics) is not directly applicable here. The "experts" would be the scientists and microbiologists performing the tests and validating against the established standards.

4. Adjudication method for the test set:

• Adjudication methods (like 2+1 or 3+1 for human readers) are not applicable to this type of device testing. The device's performance is objectively measured against predefined scientific and engineering specifications (e.g., spore count, D-value, temperature control, fluorescent detection, chemical indicator color change).

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:

• No, an MRMC comparative effectiveness study was not done. This device is a biological indicator and an auto-reader, not an AI-assisted diagnostic tool that relies on human interpretation. The "reader" in this context is the auto-reader detecting a fluorescent signal.

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

• Yes, a standalone performance assessment was done. The entire set of tests described in the "Comparative Data" section evaluates the performance of the 3M™ Attest™ 1491 BI (biological component) and the 3M™ Attest™ 490 Auto-reader (the automated reading device/algorithm) either individually or as a system. For example, the auto-reader's ability to "automatically read the 1491 BI for a fluorescent result within 30 minutes" and maintain incubation temperature is a standalone performance measure. The "Reduced Incubation Time" test specifically compares the device's automated fluorescent result to the "conventional incubation time of 7 days," which serves as a gold standard for a biological indicator's performance.

7. The type of ground truth used:

• The ground truth employed for the various tests includes:
  • Microbiological Standards: For spore characterization, D-value, population count, survival/kill times, recovery media, and component inhibition, the ground truth is established by recognized microbiological culturing and enumeration techniques, adhering to standards like ANSI/AAMI/ISO 11138-1 and -3, and United States Pharmacopeia (USP) chapters.
  • Physical/Chemical Standards: For the chemical process indicator, the ground truth is the expected color change upon steam exposure. For the auto-reader's temperature maintenance, the ground truth is a precisely calibrated temperature range (56 +/- 2°C).
  • Reference Standard (Conventional Incubation): For the "Reduced Incubation Time," the ground truth is the result obtained after the "conventional incubation time of 7 days," which is the established method for determining biological indicator failure/pass.

8. The sample size for the training set:

• The document does not mention a "training set" or "training data" in the context of machine learning. This device does not appear to be an AI/ML-based system that requires a distinct training phase. The system relies on enzyme detection and physical measurements, calibrated and validated against established standards.

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

• As a training set for an AI/ML algorithm is not discussed or implied for this device, this question is not applicable. The device's operational parameters and performance were likely developed and validated through iterative engineering and experimental testing based on scientific principles of microbial inactivation and enzyme activity, guided by the aforementioned industry standards.

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3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate I.V. Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver.

Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and viruses* and yeast, and protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

• In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.

This document is a 510(k) Premarket Notification for a medical device (3M™ Tegaderm™ CHG Dressing) and primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way you've described for an AI/device performance evaluation.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The document describes the device's function and properties, and mentions "in vitro testing" as proof of certain antimicrobial effects, but it does not detail those tests with acceptance criteria or performance metrics in a structured format as typically found in clinical performance studies.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The document focuses on demonstrating substantial equivalence to predicate devices and inherent properties.
• Reported Device Performance:
  • "In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing."
  • "In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage."

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

• Sample Size: Not specified. The descriptions refer to "in vitro testing" which typically involves laboratory experiments with microbial cultures, not patient-derived "test sets" in the context of clinical studies.
• Data Provenance: The testing is described as "in vitro testing," meaning laboratory-based. No country of origin for the data is mentioned, nor is it classified as retrospective or prospective study design.

3. 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)

• Not applicable as this document describes in vitro (laboratory) tests, not human- expert-interpreted data.

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

• Not applicable. The "test set" refers to microbial cultures in a lab, not data requiring expert adjudication.

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

• Not applicable. This is a medical dressing, not an AI diagnostic device. No human reader or AI component is involved.

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

• Not applicable. This is a medical dressing, not an algorithm.

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

• Ground Truth: For the "in vitro testing," the ground truth would be established by standard microbiological methods (e.g., direct measurement of log reduction, observation of zone of inhibition, successful barrier against organisms). This is empirical, objective lab data rather than expert consensus or pathology.

8. The sample size for the training set

• Not applicable. As a medical dressing, there is no "training set" in the context of machine learning or AI.

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

• Not applicable.

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