(53 days)
The Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
Similar to the parent Modified Browne Packaging and Label Steam Process Indicator, the proposed VERIFY® STEAM Value Indicators consists of indicator ink applied to a suitable substrate, i.e. packaging material, self-adhesive labels, tapes, tags, inserts, etc. Modifications to the parent indicator to produce the proposed VERIFY® STEAM Value Indicators included changes to the indicator ink composition, modification to the process used for application of the indicator ink to the substrates, and minor changes to the suite of compatible substrates. The modifications to the indicator ink composition were made to produce two variants with different color change schemes and improve the "printability" of the ink.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VERIFY® STEAM Value Indicators:
It's important to note that the provided text is a 510(k) summary, which often provides a high-level overview. Therefore, specific details common in a full study report (like detailed sample sizes for all tests, ground truth methods for training sets, or MRMC study results) are not always present in this type of document.
Acceptance Criteria and Device Performance Study for VERIFY® STEAM Value Indicators
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to the ANSI/AAMI ST60 standard for Class I process indicators for steam sterilization as the basis for acceptance criteria. The document states that testing demonstrates compliance with "applicable requirements." However, it does not explicitly list specific numerical acceptance criteria from this standard or the precise results demonstrating conformance against those criteria. It only provides a general statement of compliance.
Hypothetical Table (based on general understanding of Class I indicators and implied performance):
| Acceptance Criterion (from ANSI/AAMI ST60 for Class I) | Reported Device Performance |
|---|---|
| Visual Color Change Range: Change from initial color to final color when exposed to steam. | "undergo a visual color change when exposed to steam" |
| Activation Temperature Range: Color change occurs within specified temperature range. | "in a temperature range of 121℃ to 135℃ (250°F to 275°F)" |
| Non-Exposure Indication: No color change when not exposed to sterilant. | Implied to be met, but not explicitly stated. |
| Stability (Shelf-life): Maintain performance over specified shelf-life. | Not explicitly stated in the provided text. |
| Substrate Compatibility: Perform as designed on compatible substrates. | "performed as designed under in use conditions using all of the compatible substrates." |
| "Printability" and Ink Composition: Improved and two variants for color change schemes. | "two variants with different color change schemes and improve the 'printability' of the ink." |
Note: The provided text primarily focuses on the intended use and modifications rather than a detailed breakdown of quantitative acceptance criteria and results. The statement "Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60" is the primary evidence of meeting acceptance criteria.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing" and "additional testing" but does not provide specific numbers of indicators or test runs.
- Data Provenance: The testing was performed by "Albert Browne Ltd.", the manufacturer, which is based in the United Kingdom. The description implies prospective testing conducted specifically for this submission, as it discusses demonstrating conformance and performance "under in use conditions."
3. Number of Experts and Qualifications for Ground Truth for Test Set
- The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. For a physical/chemical indicator, ground truth is typically established by the physical parameters of the test (e.g., verified steam sterilization cycles, controlled temperature environments) and objective observation of the color change. The "ground truth" here is the physical conditions applied to the indicator, not necessarily subjective expert interpretation of the indicator's performance against a human gold standard.
4. Adjudication Method for Test Set
- Not applicable/Not specified. Given the nature of a chemical indicator (a binary outcome of color change/no color change, or specific color transition), adjudication by multiple human observers in the way medical imaging requires is typically not relevant. The assessment of whether a color change occurred is generally objective and may be performed by trained technicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not applicable to a physical/chemical sterilization process indicator. MRMC studies are used for diagnostic interpretation of complex data (like medical images) where human readers are making subjective judgments, and the goal is to evaluate if an AI tool improves their diagnostic accuracy or efficiency. A steam indicator's function is a direct chemical reaction, not subject to human interpretation in the same way.
6. Standalone Performance Study (Algorithm Only)
- Yes, implicitly. The entire performance testing described ("Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization") is a standalone performance assessment of the indicator itself. There is no "human-in-the-loop" once the indicator is placed in the sterilizer; its performance is entirely dependent on its chemical composition and the physical conditions. The "algorithm" here is the chemical reaction of the indicator ink.
7. Type of Ground Truth Used
- The ground truth is based on physical parameters and standards. The indicators are subjected to controlled steam sterilization conditions that are themselves validated against established performance standards (e.g., temperature, time, steam quality). The "ground truth" is that these specific, controlled conditions were met, and the indicator's proper color change response confirms it functioned as expected under those conditions. The ANSI/AAMI ST60 standard provides the benchmarks for these physical parameters.
8. Sample Size for the Training Set
- Not applicable/Not explicitly stated. For a chemical indicator, there isn't typically a "training set" in the sense of machine learning algorithms. The development process involves chemical formulation and iterative testing/refinement by the manufacturer. If one were to loosely interpret "training," it would be the cumulative R&D and calibration work to achieve a reliable chemical reaction, but this wouldn't have a distinct "sample size" in the same way an AI model's training data would.
9. How Ground Truth for the Training Set was Established
- Not applicable/Not explicitly stated. As there isn't a "training set" in the machine learning sense, the method for establishing ground truth for it is not provided. The development of such indicators relies on chemical engineering principles, experimental testing, and adherence to performance specifications, where the "ground truth" during development is the consistent and accurate response of the chemical formulation to defined physical conditions.
§ 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).