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The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.

The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.

The provided text describes the Green Card Bowie-Dick Test (BD115), a sterilization process indicator. The study detailed is a non-clinical performance test to verify the device meets applicable standards for Class 2 indicators for Bowie and Dick-type air removal tests.

Here's the breakdown of the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The testing was conducted on 3 manufactured lots of the Green Card Bowie-Dick Test.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective testing conducted by the manufacturer (SteriTec Products, Inc., located in Englewood, CO, USA).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided in the document. The ground truth for this type of device (a chemical indicator for sterilization) is established through physical measurements of temperature and air presence in a controlled sterilization environment, not through expert interpretation of images. The criteria refer to thermocouple graphs for temperature verification.

4. Adjudication Method for the Test Set:

• Not applicable or not specified. The performance of this device is assessed against objective physical and chemical changes (color change, temperature differences) based on defined ANSI/AAMI/ISO standards, rather than subjective human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not relevant for this device. An MRMC study is typically performed for AI/image analysis systems where human readers interpret medical images, and the AI assists in that interpretation. The Green Card Bowie-Dick Test is a chemical indicator that provides a direct visual result.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, effectively. The performance testing described is for the device itself to objectively meet specific physical and chemical criteria. The "algorithm" here is the chemical reaction of the indicator. The acceptance criteria are based on whether the indicator changes color as expected under specific sterilization conditions, without human interpretation influencing the measurement of those conditions (e.g., thermocouple readings). The visual interpretation of the color change by a human is the final step, but the "performance" of the device in demonstrating the condition is intrinsic to the device itself.

7. Type of Ground Truth Used:

• The ground truth is established through objective physical measurements in controlled sterilization environments, specifically:
  • Temperature measurements using thermocouples within a "Standard Test Pack" and at the drain, to verify specific temperature differences (e.g., no greater than 0.5°C difference for pass, 2°C or greater for fail).
  • Defined steam sterilization cycles (e.g., 270°F/132°C and 273°F/134°C for 3.5 minutes).
  • Absence or presence of residual air engineered into the test conditions.
  • Direct observation of color change (uniform green for pass, non-uniform with purple for fail) and color density as per ANSI/AAMI/ISO standards.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This is a physical chemical indicator, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is inherent to its material composition and design, which is validated through a test set of manufactured lots.

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

• Not applicable. As explained above, there is no "training set" for this device in the context of an AI/ML algorithm. The device's inherent chemical and physical properties are designed to react to specific sterilization conditions, and its performance is validated against established industry standards for those reactions, not "trained" on data.

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SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.

Critical Parameters in a standard hospital pre-vacuum steam sterilizer

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The provided text is an FDA 510(k) clearance letter for a medical device called the "Emu-Graph 4 Emulator, Model No .: CI 144." This document describes the device, its intended use, and indicates that it has been found substantially equivalent to a predicate device.

Crucially, this document is a regulatory clearance letter, not a study report. It states the intended use and performance requirements (acceptance criteria in this context), but it does not contain the details of the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information regarding the study design, sample sizes, ground truth establishment, or expert qualifications because this information is not present in the provided text.

However, I can extract the acceptance criteria and the reported device performance as stated in the "Indications for Use" section.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The following information cannot be provided from the given document as it describes a regulatory decision, not the underlying study report:

2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done. (This device is a chemical indicator, not an AI algorithm).
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

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The provided text is related to a 510(k) premarket notification for a medical device called "SteriTec Instant Readout Chemical Integrator Challenge Pack, Model No.: I.T 105". This document is an FDA clearance letter and an "Indications for Use" statement. It does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving device performance in the context of advanced AI/ML algorithms.

Specifically, the document refers to a chemical indicator and its performance requirements according to FDA Chemical Indicator Guidelines and ISO 11140-1:2005. The "performance" in this context refers to the chemical integrator changing color to indicate successful sterilization conditions, not the performance of an AI/ML algorithm.

Therefore, many of your requested points are not applicable or cannot be extracted from this document, as they relate to AI/ML device studies.

However, I can extract the following information based on the document:

Acceptance Criteria and Reported Device Performance (as a chemical integrator)

The device is a chemical integrator, and its performance is described in terms of its response to specific steam sterilization conditions. The "Indications for Use" statement outlines the critical parameters and the expected response.

Specific Performance (Critical Parameters in hospital steam sterilizers - likely referring to minimum exposure times required to achieve "pass" indication for different thresholds, or absence of "pass" for under-exposure):

| General Performance: The SteriTec Instant Readout Chemical Integrator Challenge Pack "meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." The Integrator Challenge Pack "monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F)." "When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green." "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."

Specific Performance Thresholds (as described for the device): The table in the "Indications for Use" provides the "Critical Parameters" for the device, which, in the context of a chemical integrator, define the conditions under which it is expected to respond. The "Indicator "A", "B", "C"" columns likely correspond to different performance thresholds within the ISO standard or internal validation, showing the minimum exposure times at which the integrator should indicate a "pass" or "fail" for various conditions. For a chemical integrator, "performance" means accurately reflecting the conditions it is designed to monitor (e.g., changing color when sterilization conditions are met, and not changing color when they are not). The document implies the device operates according to these thresholds.

132°C (270°F) / Pre-Vacuum:

• Indicator "A": 4 minutes
• Indicator "B": 10 minutes
• Indicator "C": 20 minutes

135°C (275°F) / Pre-Vacuum:

• Indicator "A": 3 minutes
• Indicator "B": 8 minutes
• Indicator "C": 16 minutes

(Note: The document doesn't explicitly state "pass/fail" results for these specific indicator times, but rather lists them as the "Critical Parameters" the device monitors and for which its performance is defined against, i.e., it must behave as expected at these time points for each indicator type.) |
| Temperature/Sterilizer Type:

• 132°C (270°F) / Pre-Vacuum
• 135°C (275°F) / Pre-Vacuum | |

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The SteriTec Instant Readout Chemical Integrator Challenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." And, "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."

This indicates that the device underwent testing to demonstrate compliance with these established standards. However, the document does not provide the details of this study, such as its methodology, results, or specific data.

Information NOT available in the provided document (as it pertains to AI/ML studies and not applicable to this chemical indicator device):

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a physical chemical indicator, not an algorithm processing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a chemical indicator is determined by physical sterilization conditions and its visual color change.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This device doesn't involve human readers or AI assistance in a diagnostic context.
6. Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a chemical indicator, the ground truth is the actual physical parameters of the sterilization cycle (temperature, time, steam quality), verified by calibrated equipment. The "expert consensus" relates to the FDA and ISO standards defining what constitutes a successful sterilization cycle and thus a "pass" indication from the device.
8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.

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This document is a 510(k) clearance letter from the FDA for Steritec Process Indicators. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance and substantial equivalence to a predicate device, not on performance studies with specific metrics.

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SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

SteriTec Integraph-E is a steam sterilization integrator. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a sterilization indicator, SteriTec Integraph-E. It indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use.

Crucially, it does not include any details about a study with acceptance criteria, device performance, sample sizes, ground truth establishment, or expert reviews. These types of details are typically found in the 510(k) submission summary or in the actual study reports, which are not part of this clearance letter.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about a study based on the provided text.

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SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "SteriTec Bowie-Dick Mini Pak, Model No. BD 115." It is not a study report or clinical trial. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement for AI device evaluation.

The letter simply states that the FDA has reviewed the manufacturer's premarket notification and determined that the device is "substantially equivalent" to a legally marketed predicate device.

However, based on the "Indications for Use" section, we can infer the intended performance and what would constitute "acceptance" for the device's function:

1. Table of Acceptance Criteria and Reported Device Performance

The remaining information requested (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set specifics) cannot be provided from this document because:

• This is a regulatory clearance, not a scientific study report.
• The device is a chemical indicator (Bowie-Dick Mini Pak), not an AI-powered device, so concepts like "test set," "training set," "ground truth," "experts for ground truth," "MRMC study," or "AI assistance" are not applicable in this context. The "ground truth" for this type of device is the physical condition of the sterilization cycle (presence/absence of air, correct temperature/time).
• The "study" referenced in K024293 would primarily involve laboratory testing to demonstrate the chemical indicator's color change properties under various controlled conditions (e.g., proper sterilization, partial air removal, significant air presence) and comparison to a predicate device, rather than a clinical trial with human readers or image interpretation.

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SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum or gravity displacement steam sterilization process of 3 minutes or longer at 132° C (270° F), or a flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity displacement sterilizers. When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) clearance letter from the FDA for a device called "SteriTec Integraph Flash," which is a sterilization process indicator.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and mentions its indications for use. However, it does not describe the data or studies that led to this determination.

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