(407 days)
The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.
The Browne TST Single Use Bowie Dick Type Test Pack is a paper sheet containing an indicator figure wrapped in multiple layers of paper which is designed to monitor air removal and steam penetration during a 132 °C (270°F) or 134°C (273°F) steam autoclave processing cycle with a hold time of 3-4 minutes. The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.
This document describes the Browne TST Single Use Bowie-Dick Type Test Pack, a chemical sterilization process monitor. Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Air Removal & Steam Penetration during Autoclave Processing: Demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle. | The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration. |
| Temperature Depression Sensitivity: Detects a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. | Performance testing showed that the sensitivity of the Test Packs is sufficient to detect a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. |
| Performance in Loaded Chamber: Sensitivity of the Test Pack is not affected by the presence of a loaded chamber. | Additional testing conducted in a loaded chamber demonstrated that the sensitivity of the Test Pack was not affected by the presence of the load. |
| Color Change Mechanism: Yellow to blue color change. | Achieves a yellow to blue color change. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the performance testing. It refers to "performance testing" and "additional testing" without quantifying the number of tests conducted.
The data provenance is not explicitly stated as country of origin, retrospective or prospective. However, the submitter is from the United Kingdom, and the device is being submitted to the FDA in the US, suggesting the testing likely occurred in a calibrated lab environment for regulatory submission. The testing appears to be prospective, demonstrating the device's function under specified conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of human experts to establish ground truth for this device. This is a chemical indicator, where the "ground truth" is determined by the known physical conditions within the autoclave (e.g., successful steam penetration, specific temperature depression). The color change of the indicator itself is the output, and its accuracy is validated against the controlled physical parameters, not against human interpretation of an image or condition.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the "ground truth" for a chemical indicator is the physical state of the autoclave, not an interpretation by human experts that would require adjudication. The color change is a direct physical response.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical indicator, not a diagnostic imaging device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was conducted. The performance testing described evaluates the device's ability to accurately reflect the autoclave conditions (air removal, steam penetration, temperature depression) independently. The color change is a direct output of the device's chemical properties reacting to the environment, not requiring human interpretation as part of its primary function.
7. The Type of Ground Truth Used:
The ground truth used is based on physical parameters and controlled conditions within an autoclave. This includes:
- Adequate air removal and steam penetration: Established by controlling the autoclave cycle to ensure these conditions are met.
- Specific temperature depression: Artificially creating a ≥2℃ temperature depression to test the device's sensitivity.
- Loaded vs. Unloaded Chamber: Testing under both conditions to see if the device's performance is affected.
The color change of the indicator then correlates with these known physical states.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device is a passive chemical indicator, not an AI/machine learning algorithm that requires training data. Its function is based on fixed chemical properties.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a chemical indicator.
§ 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).