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The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure
4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure
5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
   The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
   54℃, 42 min, EO 600 mg/l, RH 60±10%
   37℃,75 min. EO 600 mg/l. RH 60±10%
   55°C, 36 min, EO 736 mg/l, RH 50±10%
   37°C, 75 min, EO 736 mg/l, RH 50±10%
   55°C, 35 min, EO 759 mg/l, RH 50±10%
   37°C, 75 min, EO 759 mg/l, RH 50±10%

The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.

The acceptance criteria and the study proving the device meets these criteria are detailed in the "Summary of Non-Clinical Testing" section of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

• Pass Condition (Green):
  • 54°C, 42 min, EO 600 mg/l, RH 60%
  • 37°C, 75 min, EO 600 mg/l, RH 60%
  • 55°C, 36 min, EO 736 mg/l, RH 50%
  • 37°C, 73 min, EO 736 mg/l, RH 50%
  • 55°C, 35 min, EO 759 mg/l, RH 50%
  • 37°C, 73 min, EO 759 mg/l, RH 50%
• Fail Condition (Brown, Brown-red, Brown-yellow):
  • 49°C, 33.6min, EO 510 mg/l, RH 60%
  • 32°C, 60 min, EO 510 mg/l, RH 60%
  • 50°C, 28.8min, EO 625mg/l, RH 50%
  • 32°C, 58.4min, EO 625mg/l, RH 50%
  • 50°C, 28 min, EO 645 mg/l, RH 50%
  • 32°C, 58.4min, EO 645mg/l, RH 50% | Passed |
    | Testing in "No EO Gas" cycles | When tested in cycle with temperature 60°C±2°C, RH≥85%, time 90 min±1min, the indicator should not achieve end-point color. | Passed |
    | Testing against biological indicator | The integrator does not achieve end-point color before the biological indicator is inactivated and demonstrates parallel performance to the biological indicator. | Passed |
    | Single parameter variation testing | Variation of one parameter while other ones are maintained steady. Gas-Chex Indicator should not reach specified end-point green color. | Passed |
    | Testing in cycles with parameters typical for healthcare | Color change from brown-red to green. | Passed |
    | Biocompatibility study and ink transfer test | Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation with history on the market.

Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
| End-point stability and shelf-life study | Gas-Chex indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 3 months.

Meet specifications after real-time 36 months shelf-life exposure. | Passed |

Detailed Information on the Study:

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

   • The document does not specify the exact number of individual Gas-Chex Indicators or test runs used for each test. Instead, it states that various conditions (e.g., specific temperatures, EO concentrations, RH, and exposure times) were tested.
   • Data Provenance: The tests were performed to demonstrate conformance with FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003. These are laboratory-based, non-clinical tests conducted in controlled environments (Ethylene Oxide BIER vessel). The specific country of origin is not explicitly stated for the testing location, but the applicant company is located in Long Island City, New York, USA. The study design is prospective in nature as it involves planned testing under specific conditions.

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

   • This type of device (chemical indicator for sterilization) does not typically involve human expert interpretation of complex data for ground truth establishment.
   • The "ground truth" is established by the known, objective physical and chemical parameters of the sterilization cycles (e.g., temperature, time, EO concentration, RH) and the expected color change response of the indicator based on its design and the established standards (e.g., ISO 11140-1:2014 and FDA guidance). The color change itself (brown-red to green, or remaining brown-red/brown-yellow) is a direct, observable, and objective outcome.
   • Therefore, no human experts are described as being used in an "adjudication" sense to establish fundamental ground truth for the device's performance in these non-clinical tests.

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

   • No adjudication method from human experts is described since the assessment of the chemical indicator's color change is a direct observation against defined criteria (e.g., "green" for pass, "brown, brown-red, brown-yellow" for fail). This is a purely objective assessment against pre-defined color states.

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:

   • No MRMC comparative effectiveness study was done. This type of study is not applicable to a chemical sterilization indicator, which is a passive device with a direct visual output, rather than an AI-driven diagnostic or interpretative tool that assists human readers.

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

   • Not applicable. The device is a chemical indicator that changes color; there is no algorithm involved. Its performance is inherent to its chemical formulation and physical design.

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

   • The ground truth is based on the known, controlled physical and chemical parameters of the Ethylene Oxide sterilization cycles (temperature, Ethylene Oxide concentration, relative humidity, and exposure time) generated in a Resistometer (BIER vessel). The expected outcome (color change to green for successful sterilization parameters, or no change/partial change for insufficient parameters) is derived from established sterilization science and regulatory standards for chemical indicators.

8. The sample size for the training set:

   • Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no concept of a "training set."

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

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

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The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The Steri-Dot process indicator can be used in the following EO sterilization cycles:

1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
3. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure
4. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
5. 55°C, 759 mg/l EO, ≥35% RH, l hour exposure
6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure

The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.

The provided document describes the Steri-Dot® Process Indicator, a chemical indicator for Ethylene Oxide (EO) gas sterilization. The information primarily focuses on non-clinical testing to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Summary of Non-clinical Testing" table.

Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
| End point stability and shelf-life study | To confirm that Steri-Dot process indicator has acceptable stability after processing when achieved and not achieved end point color (parameters when tested using real-time shelf-life exposure method). | Criteria not explicitly stated in the provided text for this row. | Implied Passed, as overall conclusion is positive. |
| Adhesive test – healthcare applications | The purpose of the test is to evaluate if the adhesive is suitable for its function and does not deteriorate during sterilization process. | The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after Steri processing. | Passed |

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

The document describes non-clinical laboratory testing of a device rather than a study involving human data or a "test set" in the context of AI/machine learning. Therefore:

• Sample size: Not explicitly stated in terms of number of indicators tested for each condition. The testing is described as fulfilling the requirements of ISO standards and demonstrating performance.
• Data provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the Steri-Dot Process Indicator itself.

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

This section is not applicable to this document. The device is a chemical indicator that changes color. The "ground truth" for its performance is determined by the physical chemical reaction and visual observation based on established standards (e.g., ISO 11140-1:2014). There is no mention of expert readers or human interpretation of complex images/data to establish ground truth as would be the case for an AI medical device.

4. Adjudication Method for the Test Set

This section is not applicable. As it's a chemical indicator with a clear color change endpoint, there is no ambiguity requiring an adjudication method by multiple human readers.

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

This section is not applicable. An MRMC study is relevant for AI devices where human readers interpret medical images or data. The Steri-Dot Process Indicator is a chemical indicator, not an AI-powered diagnostic tool. There are no human readers involved in its direct "performance" evaluation beyond visual confirmation of the chemical reaction.

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

This section is not applicable. The Steri-Dot Process Indicator is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its material composition and chemical reaction, not a computational model.

7. The Type of Ground Truth Used

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

• Standardized Chemical Reaction: The chemical indicator's color change in response to specific sterilization parameters (temperature, humidity, EO concentration, exposure time).
• Compliance with International Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators. This standard defines the expected color changes under various exposure and non-exposure conditions to ethylene oxide.
• Visual Observation: The "result" column in the table simply states "Passed," implying that the visual color change (or lack thereof) met the specified acceptance criteria.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical device, not an AI model requiring a training set.

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

This section is not applicable for the same reason as point 8.

In summary: The provided document is a 510(k) summary for a physical chemical indicator. It details the product's function, mechanism, and non-clinical performance testing against established ANSI/AAMI/ISO standards. Many of the questions you posed (e.g., sample size for AI test/training sets, expert consensus, MRMC studies) are primarily relevant for AI/software as a medical device (SaMD) rather than a simple chemical indicator. The "acceptance criteria" and "study proving device meets acceptance criteria" here refer to laboratory testing demonstrating compliance with performance standards for physical chemical indicators.

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