(108 days)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
The provided text describes the regulatory filing (510(k) submission K171003) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H. This document details the non-clinical performance evaluation of a device designed to monitor sterilization processes, not an AI/ML medical device for diagnosis or prognosis involving human expert review of medical images.
Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "training set details," are not applicable to this specific device and the provided documentation. The study described is a laboratory performance test of a biological indicator and an auto-reader, not a study evaluating human reader performance with or without AI assistance on medical images.
However, I can extract the relevant information from the document to answer the applicable parts of your request:
Device and Study Overview
The device under review is the 3M™ Attest™ Rapid Readout Biological Indicator 1295, used in conjunction with the 3M™ Attest™ Auto-reader 490H. This submission addresses a software change to the Auto-reader to reduce the final fluorescent readout time from 4 hours to 24 minutes. The biological indicator itself (1295 BI) has the same design, materials, and fundamental scientific technology as the previously cleared device.
The "study" in this context refers to non-clinical performance testing conducted to demonstrate that the device, with the reduced readout time, still functions effectively as a biological indicator for monitoring vaporized hydrogen peroxide sterilization processes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Passed" results for each test. The actual quantitative acceptance thresholds are not explicitly listed in this summary, but the results confirm they were met.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Positive Control | Biological indicator shows growth/fluorescence. | Passed |
| Survival Time ≤ 5 seconds | Biological indicator shows growth/fluorescence. | Passed (Survival Time = 5 seconds) |
| Kill Time ≥ 7 minutes | Biological indicator shows no growth/fluorescence. | Passed (Kill Time = 7 minutes) |
| Reduced Incubation Time: Alignment with 7-day conventional incubation time | > 97% alignment | Passed (Meets FDA's requirements for Reduced Incubation Time with > 97% alignment) |
| Final fluorescent readout time | 24 minutes | 24 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of biological indicators tested for each performance criterion (e.g., how many BIs were used to determine survival time or kill time, or for the reduced incubation time study). It only states "No clinical data was included in this premarket application submission," indicating the tests were non-clinical.
- Data Provenance: The tests would have been conducted in a laboratory setting by 3M Company. The document does not specify the country of origin of the data, but 3M's contact address is St. Paul, Minnesota, USA. The studies are prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate the performance with the new readout time.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a non-clinical, in-vitro performance study of a biological indicator and auto-reader. Ground truth is established by the known conditions of the sterilization cycles (e.g., exposure time to sterilant) and the inherent biological response of the Geobacillus stearothermophilus spores. The "truth" is the presence or absence of viable spores after treatment, which is determined by the biological indicator's function, not by human expert interpretation of an outcome.
4. Adjudication Method for the Test Set
- Not Applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The device's readout (fluorescence) is an objective, automated measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is a non-clinical performance study of a device, not a study evaluating human reader performance (with or without AI assistance).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in essence. The testing described is a standalone performance evaluation of the integrated system (biological indicator + auto-reader algorithm) without human intervention in the interpretation of the results. The 490H Auto-reader automatically interprets the biological indicator and provides a fluorescent readout. The "algorithm" here is the system's ability to detect fluorescence within a specific incubation time.
7. The Type of Ground Truth Used
- Biological/Chemical Performance & Controlled Environmental Conditions: The ground truth for the "Passed" results is based on established scientific principles for biological indicators:
- Viable spores (positive control): Known viability and growth in ideal conditions.
- Survival Time: Exposure to a specific, short duration of sterilant where spores are expected to survive.
- Kill Time: Exposure to a specific, longer duration of sterilant where all spores are expected to be killed.
- Reduced Incubation Time Alignment: Comparison to the conventional, well-established 7-day incubation method, serving as a gold standard for biological indicator performance. The fluorescence indicates the presence (or absence) of enzyme activity from viable spores.
8. The Sample Size for the Training Set
- Not Applicable. This device does not use machine learning or AI models that require "training sets" in the conventional sense. The "training" of the device is its design and manufacturing to function according to biophysical principles, not an iterative data-driven process.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8). The device's function is based on the biological activity of bacterial spores and their response to sterilization, which is a well-understood and established scientific principle in microbiology and sterilization.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).