(38 days)
The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
Like the parent Browne Packaging and Label Steam Indicator, the proposed Modified Packaging and Label Indicator consists of indicator ink applied to a suitable substrate using a flexographic printing method. When exposed to steam in the temperature range of 121°C to 135°C (250°F to 275°F), the indicator changes color. The parent indicator changed color from pink to purple. The color change for the proposed indicator is from pink to dark purple. Neither the proposed or parent indicator is intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a steam process.
Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study:
The document describes a "Special 510(K) Summary" for a modified steam process indicator, comparing it to a predicate device. The core of the submission revolves around demonstrating that the modified device performs similarly to or better than the predicate device and meets relevant standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Visual color change when exposed to steam | Indicator undergoes a visual color change from pink to dark purple when exposed to steam. |
| Effective temperature range of 121°C to 135°C (250°F to 275°F) | Predicate Device: Indicated a color change in a temperature range of 121°C to 135°C (250°F to 275°F). |
| Modified Device: The effective temperature range was explicitly "expanded to include a 135°C steam sterilization cycle." Performance testing "showed that the indicator performed as designed in 132°C, 134°C, and 135°C sterilization cycles." | |
| Conformity to ANSI/AAMI ST60 for Class I process indicators for steam sterilization | Albert Browne Ltd. "performed testing which demonstrates that the Modified Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization." |
| Indicator ink compatibility with multiple substrates | The indicator ink composition was modified "to make the ink compatible with multiple substrates," which was a design goal. |
| Improved intensity of visual color change | The indicator ink composition was modified "to improve the intensity of the visual color change." The parent changed from pink to purple, and the proposed changes from pink to dark purple. |
| Chemical reaction for color change is identical to predicate | The chemical reaction that induces the indicator ink to change color is "identical for the parent and proposed indicators." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the test set or the country of origin for the data. It refers to "testing" and "additional testing" performed by Albert Browne Ltd., implying internal validation. Given Albert Browne Ltd. is located in the United Kingdom, it's highly probable the testing was conducted there. The studies appear to be prospective, as they were performed to demonstrate conformity of a newly modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for visual color change interpretation. For a simple visual process indicator, the "ground truth" is likely based on defined color standards (e.g., a specific shade of dark purple indicating success), rather than subjective expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for reviewing test results. For a device with a direct visual output, it's unlikely an adjudication process by multiple readers would be specified unless there were ambiguous color changes, which are not mentioned.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a simple chemical process indicator, not an AI-powered diagnostic tool. The performance is assessed by its physical color change, not by human interpretation of complex images or data that AI would assist with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance for an AI device. As this is a chemical process indicator, there is no algorithm involved, and therefore no standalone algorithm performance was conducted. The device's function is entirely chemical and physical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on physical and chemical properties and compliance with a recognized standard.
- Physical: The device must undergo a visible color change. The document defines the target color change (pink to dark purple).
- Chemical: The underlying chemical reaction for the color change must be identical to the predicate device.
- Standard Compliance: The device must conform to the "applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization." This standard itself defines the criteria for what constitutes an effective indicator.
8. The sample size for the training set
This device is not an AI/machine learning device, so there is no training set and therefore no sample size for one.
9. How the ground truth for the training set was established
As there is no training set for an AI/machine learning model, this question is not applicable.
§ 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).