Search Results

The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.

The Reliance CI is a single-use chemical indicator with indicator ink printed on one end that was developed to monitor the peracetic acid (PAA) dose at the point of use in a Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.

The document provides a 510(k) summary for the Reliance™ CI Process Indicator, a chemical indicator for monitoring peracetic acid dose in endoscope processing systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates that "Performance testing was conducted to demonstrate that the Reliance CI is an effective monitor for the circulating peracetic acid dose." However, it does not specify the sample size used for this performance testing.

Regarding data provenance, the testing was conducted in the context of the device's development by Albert Browne Ltd., a subsidiary of STERIS Corporation, which is based in the United Kingdom. The exact location of the testing facility is not explicitly stated, but it would presumably be within the company's research and development arm. The testing described is inherent to the development and validation of the device, making it prospective in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" for chemical indicators like this is typically established by controlled laboratory conditions where the concentration of the active chemical (peracetic acid in this case) is precisely known and measured by analytical methods, rather than by human expert consensus or pathology. The assessment of color change is likely objective based on defined reference colors.

4. Adjudication method for the test set

This information is not provided. Given that the "ground truth" for a chemical indicator's color change is typically based on objective chemical concentrations and predefined color references, a formal adjudication method by experts (like 2+1, 3+1) is usually not applicable in the same way it would be for image-based diagnostic devices. The assessment is likely based on comparing the indicator's color to a standard color chart or reference after exposure to known concentrations.

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

Not applicable. This device is a chemical indicator, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction and visible color change, which is then interpreted by a human user (by observing the color). There is no "algorithm only" performance separate from its physical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the Reliance™ CI Process Indicator is based on precisely measured and controlled concentrations of peracetic acid (PAA) dose (specifically, 9,000 mg/L PAA min. and 11,500 mg/L PAA min.) within the specified Reliance™ EPS Endoscope Processing System. The efficacy of the indicator is determined by its ability to accurately reflect these known chemical concentrations through its defined color change.

8. The sample size for the training set

Not applicable. This document describes a chemical indicator, not a machine learning or AI-based device that requires a training set. The performance is based on chemical and physical properties, not trained algorithms.

9. How the ground truth for the training set was established

Not applicable. As stated above, this is not an AI/machine learning device, so there is no "training set" or establishment of ground truth for such a set.

Ask a specific question about this device

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F) or an ethylene oxide sterilization process.

The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicitly stating quantitative acceptance criteria. Therefore, the acceptance criteria are inferred from the device's intended use and the performance characteristics described for both the proposed and predicate devices. The core criterion is the reliable and accurate visual color change upon exposure to the specified sterilization processes within the defined temperature ranges.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the test set.

• Data Provenance: The studies referenced (K991418 and K060103) were conducted by Albert Browne Ltd., a UK-based company. This suggests the data provenance is likely from United Kingdom laboratories/facilities. The studies were retrospective in the sense that the results from previous submissions were used to support the current device. However, the current submission also states that Albert Browne Ltd. performed additional testing for "in use conditions," which would be more prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given that the device is a chemical indicator with a clear visual output, ground truth would likely be established through physical/chemical laboratory testing and adherence to recognized standards, rather than expert interpretation of complex images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For a chemical indicator with a distinct color change, adjudication (in the sense of resolving conflicting interpretations) is usually not applicable. The assessment would likely involve objective observation of the color change against a reference and/or instrumental analysis to confirm the chemical reaction, rather than subjective human interpretation requiring consensus.

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 used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. The VERIFY® STEAM and EO Load Record Card is a chemical process indicator, not a diagnostic imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The concept of "standalone performance" for this device is not directly applicable in the way it is used for AI algorithms. The device itself is standalone in its function as a chemical indicator. Its performance is evaluated by observing the chemical reaction (color change) to a sterilization process. There is no "algorithm" in the conventional AI sense for this mechanical/chemical device. The performance data comes from laboratory tests validating the chemical reaction to sterilant exposure.

7. The Type of Ground Truth Used

The ground truth used for this device would be based on physical and chemical validation against established sterilization parameters. This means:

• Known sterilization conditions: Exposing the indicators to precisely controlled steam (at specified temperature and time) or ethylene oxide (at specified concentration, humidity, temperature, and time) processes.
• Failure conditions: Exposing the indicators to suboptimal or failed sterilization cycles to ensure they do not change color or show an inappropriate change.
• Reference standards: Comparing the observed color change to a known standard representing a successful sterilization.

Essentially, the "ground truth" is the objective physical and chemical reality of whether adequate sterilization conditions were met.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable to this device. This product is a chemical indicator, not an AI/machine learning algorithm that requires data for training. The performance of the indicator is based on its inherent chemical properties, validated through laboratory experiments, not on a machine-learning model trained on data.

9. How the Ground Truth for the Training Set Was Established

As stated above, there is no "training set" in the context of AI/machine learning for this device. The chemical properties of the indicator inks were developed and tested based on established scientific principles of chemical reactions to heat, steam, and ethylene oxide. The ground truth for their performance was established through rigorous physical and chemical laboratory testing as described in point 7.

Ask a specific question about this device

The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.

The provided text describes a Verify® Dry Heat Label which is a chemical indicator for dry heat sterilization. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance. It only states that "Albert Browne Ltd. has performed testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the device (a chemical indicator with a clear color change) suggests that expert interpretation in the traditional sense (e.g., radiologists for medical images) might not be directly applicable for its primary function. However, the interpretation of "conforms to ANSI/AAMI ST60" would imply expert knowledge of the standard.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was mentioned. This type of study is more common for diagnostic devices where human interpretation is a critical variable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a physical chemical indicator, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is inherent in its chemical reaction.

7. The Type of Ground Truth Used

The ground truth used for this device's performance is based on:

• Physical/Chemical Reaction: The color change of the indicator ink when exposed to specific temperatures.
• Conformance to Industry Standards: Meeting the requirements outlined in ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization.
• Empirical Observation: The visual change from amber to black.

8. The Sample Size for the Training Set

This device is a chemical indicator, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an algorithm, this question is not applicable.

Ask a specific question about this device

The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:

• 270°F (132°C), 3 min. flash gravity steam sterilization .
• 270°F (132°C), 10 min. flash gravity steam sterilization .

The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash steam sterilization cycles.

Here's a breakdown of the acceptance criteria and study information for the Albert Browne Ltd. Verify Gravity Flash Integrator, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The 10 min. indicator ink's performance was not re-evaluated as it was identical to the predicate device's ink and was covered by previous 510(k) submissions (K051101 and K002937).

Study Information

Here's the detailed information about the study as requested:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size for the test set.
   • The document does not explicitly state the country of origin of the test data (though the sponsor is UK-based) nor whether it was retrospective or prospective. It refers to "simulated use testing," which implies prospective testing in a controlled environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not provided in the document. For chemical indicators, the ground truth is typically assessed by objective color change against a reference, rather than expert interpretation in the same way a medical image would be.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided in the document. Given the objective nature of a chemical indicator color change, formal adjudication methods like 2+1/3+1 are less applicable than for subjective interpretations.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This device is a standalone chemical indicator. Its performance is evaluated intrinsically based on its color-change properties when exposed to specific sterilization conditions. There is no "algorithm only" performance separate from the physical indicator itself. The "testing for the 3 min. indicator ink was repeated" and "simulated use testing" represent this standalone performance evaluation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for this device is based on objective physical/chemical criteria related to sterilization effectiveness. Specifically, the indicator must meet the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996. This standard likely specifies the precise chemical exposure conditions required to elicit the expected color change. "Simulated use testing" would involve controlled sterilization cycles known to achieve (or not achieve) specified sterilization parameters.

7. The sample size for the training set:

   • This device does not involve a "training set" in the context of machine learning or AI. It's a chemical indicator, and its performance is based on its physical/chemical properties.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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):

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.

Ask a specific question about this device

The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:

• 270°F (132°C), 10 min. flash gravity steam sterilization .
• 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .

The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color.

Here's a breakdown of the acceptance criteria and the study that proves the Verify Flash Integrator device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Verify Flash Integrator

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of individual integrators tested. However, it indicates simulated use testing was conducted.

• Sample Size: Not explicitly stated as a number of individual units.
• Data Provenance: The testing was "simulated use testing", implying a laboratory or controlled environment rather than real-world patient data. The country of origin of the device manufacturer is the United Kingdom.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a chemical indicator, "ground truth" would likely be established by objective measurements of temperature and exposure time, rather than expert interpretation of the indicator itself. The performance standard (ANSI/AAMI ST60-1996) would define the parameters for acceptance.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used for studies involving human interpretation (e.g., image analysis by radiologists) where discrepancies need to be resolved. For a chemical integrator that changes color, the outcome is objective (either it changes color appropriately or it doesn't) and would be assessed against the predefined physical parameters, not through expert consensus on its interpretation.

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 assesses how human performance improves with AI assistance compared to without it, which is not relevant for a standalone chemical sterility indicator.

6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was effectively done. The "device" in this context (Verify Flash Integrator) operates entirely by itself (changes color based on conditions). The performance testing described is inherently a standalone assessment of the device's ability to meet its specifications without human interpretation as part of its functionality. Human observation is required to read the result, but the device's performance isn't dependent on human assistance during its operational phase.

7. The Type of Ground Truth Used

The ground truth used was based on objective physical parameters and established standards:

• The specified temperature (132°C/270°F)
• The specified exposure times (10 min. or 4 min.)
• The requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Chemical indicators are physical devices, not machine learning algorithms, and thus do not have "training sets" in the conventional sense. The design and formulation of the indicator would be developed and refined through R&D, but this isn't reported as a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable because there is no "training set" for this type of device. The "ground truth" for the device's development would have been established through chemical and physical principles and laboratory testing to achieve the desired color-change response to specific sterilization parameters.

Ask a specific question about this device

The Verify® Self-Contained Biological Indicator may be used for installation testing and routine monitoring of the following steam sterilization cycle:

• 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items

The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.

This is a 510(k) summary for a biological indicator and not an AI/ML device per se. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample sizes for training/test sets) are not applicable or cannot be extracted from the provided text. The document focuses on performance testing to expand the indications for use of the biological indicator.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing was conducted," implying a controlled study, but details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/specified. For a biological indicator, the "ground truth" is determined by whether the indicator correctly registers sterilization or growth, which is a direct biological outcome, not an expert interpretation.
• Qualifications: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The performance of a biological indicator is typically assessed through direct observation of growth or lack thereof in the culture medium, not through expert adjudication in the manner of diagnostic image interpretation.

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

• MRMC Study: Not applicable. This is a biological indicator, not an AI/ML diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance: While the "device" (biological indicator) operates independently to indicate sterilization effectiveness, it's not an "algorithm" in the typical sense of AI/ML. Its performance is inherent in its biological response. The study was essentially a standalone performance validation for a specific sterilization cycle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for a biological indicator's performance is typically established by:
  • Microbiological viability: Determining the survival or inactivation of the inoculated Geobacillus stearothermophilus and/or Bacillus atrophaeus spores after exposure to sterilization conditions.
  • Sterilization Cycle Parameters: The efficacy of the sterilization cycle itself, under controlled conditions.
    The document states, "Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle," implying direct biological/physical validation against established sterilization efficacy.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.

Ask a specific question about this device

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

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.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device