(119 days)
The 3M Attest™ 390 Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicators for Steam, 1291 and 1292, at 60°C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292.
The 3M Attest™ 390G Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a final fluorescent result at 4 hours.
The Attest™ 390 and 390G Auto-readers are used in conjunction with Attest™ Rapid Readout Biological Indicators by trained personnel in central sterilization departments to monitor sterilization processes. The 390 and 390G Auto-readers, like its predecessors the Attest™ 290, 290G and 490 Auto-readers, have two functions. First, the devices serve to incubate the biological indicator (BI) at the temperature appropriate to the organism. Second, the devices determine whether a potential sterilization failure may have occurred by measuring the intensity of fluorescence produced by an enzymatic reaction associated with spore growth inside the selfcontained biological indicator.
The 390 and 390G Auto-readers include a Crusher Well in which the Attest™ Rapid Readout biological indicators are activated. After activation, the user places the biological indicator into one of the 10 color-coded Incubation Wells. The 390 and 390G Auto-readers have an incubation block controlled to the appropriate temperature for their respective biological indicators. The Auto-readers contain a LCD panel that shows the time remaining for incubation. Fluorescence detection at each incubation well is accomplished by the use of a UV LED and a photo diode sensor. As soon as a positive result is detected, a '+' sign is shown as an indication of sterilization cycle failure, accompanied by an audible alarm. At the end of the specified incubation time, if a negative result is detected, a '-' sign is shown on the LCD panel as indication of an adequate sterilization cycle. When the test is complete, as indicated by the (+) or (-) symbol on the Auto-reader LCD panel under the incubating BI, the customer records the result and disposes of the biological indicator.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Auto-reader | Testing | Acceptance Criteria | Result |
|---|---|---|---|
| 390 | Qualification testing with Attest™ 1291 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 1 hour. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390 | Qualification testing with Attest™ 1292 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 3 hours. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390 | Auto-reader Maintenance of Incubation Temperature | Maintain 60+/- 2ºC over the specified incubation period. | Pass |
| 390G | Qualification testing with Attest™ 1294 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 4 hours. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390G | Auto-reader Maintenance of Incubation Temperature | Maintain 37+/- 2ºC over the specified incubation period. | Pass |
| Both | Electrical Safety (IEC 61010-1, IEC 61010-2-010) | Compliance to specified international safety standards. | Pass |
| Both | Electromagnetic Compatibility (USA Title 47, FCC Part 15, IEC 61326) | Compliance to specified electromagnetic compatibility standards for radiated emissions, conducted emissions, and general EMC requirements. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the exact sample size (number of biological indicators or test runs) used for the qualification testing. It only mentions "Multiple lots of 3M Attest™ Rapid Readout biological indicators were evaluated for performance."
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification for submission to the FDA, suggesting the evaluation was conducted for US regulatory purposes. The data is presented as retrospective in the sense that the testing was completed prior to the submission for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The concept of "experts" and "ground truth" in the typical AI/medical device context (e.g., radiologists interpreting images) does not directly apply here. The device being evaluated is an auto-reader for biological indicators (BIs) used to monitor sterilization processes.
- Ground Truth Establishment: The ground truth for the biological indicator performance testing is established by comparing the rapid readout results (fluorescent result at 1, 3, or 4 hours) to the "conventional incubation time of 7 days." This conventional incubation time is the established method for determining sterility failure or success, and the biological indicators themselves are a well-defined standard for monitoring sterilization.
- Experts: No external human experts are mentioned as establishing this ground truth. The "ground truth" for BI performance is inherent in the established standard for biological indicator readout over 7 days.
4. Adjudication Method for the Test Set:
Not applicable in the traditional sense. The "adjudication" (comparison) is automated: the device's rapid fluorescent result is compared to the established 7-day conventional incubation result for the biological indicators. The acceptance criteria specify a "> 97% alignment" for this comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human interpretation directly impacts the outcome (e.g., diagnostic imaging). This device is an auto-reader for biological indicators, where the primary function is automated detection of fluorescence and temperature maintenance. There's no human "reader" in the loop for the primary function being tested for performance against the acceptance criteria.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed. The entire evaluation described is of the automated device (the 3M Attest™ 390 and 390G Auto-readers) in conjunction with its respective biological indicators. The device functions automatically to incubate, read fluorescence, and provide a positive/negative result without human intervention in the interpretation of the BI's sterility status.
7. Type of Ground Truth Used:
The ground truth used is based on established standard biological indicator performance (conventional 7-day incubation results) and physical measurement standards (temperature maintenance, electrical safety, EMC). Specifically, for BI qualification, it is a comparison against the long-standing 7-day incubation period result, which serves as the "gold standard" for determining bacterial growth in the BI.
8. Sample Size for the Training Set:
The document does not provide any information regarding a "training set" or its sample size. This is expected because the device likely operates based on a fixed algorithm for fluorescence detection and temperature control, rather than a machine learning model that would require a dedicated training phase. The device's performance is validated against established biological indicator principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set is mentioned or implied for a machine learning model, there is no ground truth established for a training set. The device follows pre-defined detection parameters and physical controls.
§ 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).