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The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.

The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.

The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.

This FDA 510(k) summary describes the acceptance criteria and the study proving the device (EO Chex™ Indicator Tape) meets these criteria. Since this is for a physical/chemical sterilization process indicator, the "study" is a series of non-clinical performance tests rather than a clinical trial with human subjects. Thus, many of the typical questions for AI medical devices (e.g., sample size for test set, number of experts, MRMC studies) are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the EO Chex™ Indicator Tape is its conformance to the ANSI/AAMI/ISO 11140-1:2014 standard for Type 1 process indicators, along with successful performance in typical EO sterilization cycles, biocompatibility, endpoint stability, shelf-life, and adhesive tests.

Table of Acceptance Criteria and Reported Device Performance:

• 37°C, RH 60%, EO 600mg/L, 25 min: orange-brown
• 54°C, RH 60%, EO 600mg/L, 20 min: orange-brown
  Specific Fail Conditions (no color change or markedly different):
• 37°C, RH 60%, EO 600mg/L, 3 min
• 54°C, RH 60%, EO 600mg/L, 2 min
• 60°C, RH ≥85%, EO - none, 90 min | Passed |
  | Testing in EO cycles typical for healthcare use | To demonstrate that EO Chex indicator tape achieves specified end color in typical cycles. | Color change from pink to orange-brown (in specified cycles: 38°C, 736 mg/L EO, 40-80% RH, 4.5 hrs; 38°C, 759 mg/L EO, 40-80% RH, 4.5 hrs; 54°C, 600 mg/L EO, 40-60% RH, 45 min+; 55°C, 736 mg/L EO, 40-80% RH, 1 hr; 55°C, 759 mg/L EO, 40-80% RH, 1 hr). | Passed |
  | Biocompatibility study and ink transfer test | To demonstrate that the indicator does not create biocompatibility issues for healthcare professionals and patients; and to confirm no ink transfer. | Evaluation of individual components for biocompatibility and indicators with similar formulation with long history on the market.
  Ink Transfer Requirement (ISO 11140-1:2014, 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 acceptable stability of color after processing (passed/failed conditions) and to demonstrate performance parameters are met throughout the declared shelf-life using real-time exposure. | Endpoint Stability: EO Chex indicator tape processed in Pass and Fail cycles at various time points after production and at the end of shelf-life should demonstrate stable color for 180 days.
  Shelf-Life: Met specifications after 24 months of real-time shelf-life exposure. | Passed |
  | Adhesive test healthcare applications | To evaluate if the adhesive is suitable for its function and does not deteriorate during the 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 EO processing. | Passed |

Study Details (Non-Clinical Performance Testing):

This section addresses the specific points requested, noting their applicability to a physical/chemical indicator.

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

   • The document does not explicitly state the numerical sample size for each test (e.g., number of indicator strips tested). However, the testing was conducted according to specified industrial standards (ANSI/AAMI/ISO 11140-1:2014), which implicitly define the required sample sizes and methodologies for such performance evaluations.
   • Data Provenance: Not explicitly stated, but typical for 510(k) submissions, the testing would have been conducted by the manufacturer (Propper Manufacturing Co., Inc.) or a qualified testing lab, likely within the US, as the submitter is based in New York. The data is retrospective in the sense that it was collected prior to the 510(k) submission for the purpose of demonstrating substantial equivalence.

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

   • This question is not applicable in the context of this device. Ground truth for a chemical indicator is established by physical/chemical reactions under controlled conditions (e.g., color change based on precise exposure to sterilant). It does not involve expert human interpretation of complex data like medical images. The "ground truth" is defined by the physical/chemical properties and the specified color change according to the ISO standard.

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

   • This is not applicable as the evaluation relies on objective color change criteria and physical performance metrics rather than subjective human interpretation requiring adjudication.

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:

   • This is not applicable as the device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers.

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

   • This is not applicable. The device is a physical indicator. Its "performance" is its ability to change color as designed, which is a standalone function in itself, but not an "algorithm."

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

   • The ground truth is established by objective physical and chemical criteria, specifically:
     • Defined color changes: Pink to orange-brown under specific EO sterilization conditions (Pass).
     • Absence of color change or markedly different color: Under defined challenging or insufficient sterilization conditions (Fail).
     • Adherence/physical integrity standards: For the adhesive and ink transfer.
     • Biocompatibility standards: Related to material safety.
   • These are based on the requirements of ANSI/AAMI/ISO 11140-1:2014 and the manufacturer's internal specifications derived from these standards.

7. The sample size for the training set:

   • This is not applicable. The device is a chemical indicator that operates based on material properties and chemical reactions. There is no "training set" in the machine learning sense. The development of the indicator chemistry and manufacturing process would involve internal R&D and optimization, but this is not analogous to training an AI model.

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

   • This is not applicable for the reasons stated above.

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The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterlization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The 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:

*Gravity: 121 C/250 F - 30 minutes

• Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes

• Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes

• Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes

• Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes

• *Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
  The OK Plus indicator has the following Stated Values determined in Resistometer:

• 121 C/250 F - 15 minutes

• 132 C/270 F - 4 minutes

• 134 C/273 F - 3 minutes

• 135 C/275 F - 2.9 minutes

The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam 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. OK Plus indicators are sold in boxes of 250 strips.

The indicator responds to all critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.

The provided text describes the acceptance criteria and the results of a study for the "OK Plus Indicator" device, a chemical indicator for steam sterilization monitoring.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual test in the "Summary of non-clinical testing" section. It broadly discusses "testing" and "cycles" without providing numerical quantities for the indicators tested in each scenario. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

This information is not provided in the document. The device's performance is assessed based on objective color changes and correlation with established standards (like biological indicators), rather than expert interpretation of a ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. The assessment of the indicator's performance is based on a clear, objective color change (off-white to black) as per pre-defined criteria, not subjective human adjudication of results.

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

No MRMC comparative effectiveness study is mentioned. This type of study is typically for diagnostic imaging devices where human interpretation is a key component. The OK Plus indicator is a chemical indicator with an objective color change.

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

The studies described are inherently "standalone" in the context of the device's function. The OK Plus indicator's performance is evaluated based on its chemical reaction and color change under specific conditions, without requiring human intervention for its primary function of indicating sterilization efficacy. The "result" column indicates whether the indicator "Passed" or "Failed" specific criteria, demonstrating its inherent performance.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on:

• Physical/Chemical Standards: Defined temperature, time, and steam conditions (e.g., 121°C - 15 min 00 s for black color).
• ANSI/AAMI/ISO 11140-1:2014: International standards for chemical indicators.
• FDA Guidance: "Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003."
• Correlation with Biological Indicators: The "inactivation" of biological indicators serves as a biological ground truth for sterilization efficacy.

8. Sample Size for the Training Set:

This information is not provided. Chemical indicators are typically not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical formulation, and verification is done through rigorous testing, not a training/validation split.

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

As there is no mention of a "training set" in the context of this chemical indicator, the establishment of ground truth for a training set is not applicable. The device's efficacy is proven by meeting the predetermined performance criteria against established chemical and biological standards.

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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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The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed units or loads. The indicator dots turn from white to dark brown/black when sterilization conditions, thus providing an indication of processed items.

The Steam-Dot process indicator can be used in the following steam sterilization cycles:

*Gravity: 121 C/250 F - 30 minutes

• • Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
• • Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
• • Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
• • Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
• • Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes

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

The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.

The provided text describes a 510(k) summary for a medical device called the "Steam-Dot Process Indicator." The document outlines the device's indications for use, performance criteria, and the results of non-clinical testing to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested 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

The document does not specify the exact sample sizes (e.g., number of indicators or test runs) used for each test. It broadly states that the "performance of the Steam-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators and the requirements of FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003."

The provenance of the data is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that it's a 510(k) submission, the testing would be prospective and conducted under controlled laboratory conditions, likely in the US or in a facility adhering to US regulatory standards for medical device testing.

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

This information is not applicable and not provided in the document. The "ground truth" for a chemical indicator like the Steam-Dot is based on the physical and chemical reaction of the indicator ink to specific temperature, time, and steam exposure parameters, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. There are no human "experts" establishing a subjective ground truth in this context; rather, instrumental measurements of physical parameters and observable color changes define the outcome.

4. Adjudication method for the test set

Not applicable. As described above, the determination of "pass" or "fail" for the chemical indicator is objective, based on measurable physical parameters and a defined color change endpoints. There is no subjective interpretation requiring an adjudication process by multiple reviewers.

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 that changes color to confirm exposure to sterilization conditions. It is not an AI-powered diagnostic device or an imaging system requiring human interpretation or assistance from AI. Therefore, an MRMC study is irrelevant for this product.

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

Not applicable. This is not an algorithm-only device. Its function is based on a chemical reaction, not a computational algorithm.

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

The ground truth for this device is based on defined physical and chemical parameters of steam sterilization as established by international standards (ANSI/AAMI/ISO 11140-1:2014) and regulatory guidance (FDA Guidance for industry for chemical indicators). This involves exposing the indicators to precise temperature, time, and steam conditions in controlled laboratory settings and observing the specified color change. It is an objective, laboratory-defined ground truth, not reliant on expert consensus, pathology, or clinical outcomes data.

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not an AI/machine learning model that requires a training set. Its function is based on a chemical formulation and its reaction to sterilization conditions.

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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Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

The Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes.

The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens.

The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters.

The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus.

The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position.

The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.

This is a medical device submission for a Binocular Indirect Ophthalmoscope (BIO), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like acceptance criteria tables, sample sizes for training/test sets, ground truth establishment methods, expert adjudication, MRMC studies, and standalone performance are not applicable.

The document describes the device, its intended use, and establishes substantial equivalence to a predicate device.

Here's what information can be extracted based on the provided text, and why other parts of your request are not applicable:

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

• Not Applicable. This device is a traditional medical instrument, not an AI/ML diagnostic or predictive tool. As such, there aren't "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) that are common for AI/ML algorithms. Instead, regulatory approval for such a device is based on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device. This involves meeting recognized standards (like ISO 10943:2012), conducting bench testing, and verifying manufacturing quality. The document states the device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes," which acts as the primary "acceptance criteria" for its design and performance characteristics.

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

• Not Applicable. As this is a traditional medical hardware device (an ophthalmoscope), there is no "test set" of data in the context of AI/ML or image analysis. The evaluation for substantial equivalence would involve engineering bench testing, electrical safety testing, and potentially user studies for usability, but not a dataset for an algorithm.

3. 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)

• Not Applicable. No "ground truth" or expert review of data is involved in the evaluation of this hardware device in the way it would be for an AI/ML algorithm.

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

• Not Applicable. No test set or data adjudication process as described for AI/ML.

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 is not an AI-assisted device, so no MRMC study comparing human readers with and without AI assistance would have been performed or is relevant.

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

• Not Applicable. This is a standalone hardware device used by a human clinician; it does not involve a standalone algorithm.

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

• Not Applicable. No "ground truth" in the context of clinical data assessment is relevant for this hardware device submission. Its performance is assessed against engineering standards and functional requirements.

8. The sample size for the training set

• Not Applicable. No training set, as this is not an AI/ML device.

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

• Not Applicable. No training set or ground truth establishment relevant to AI/ML.

Summary of what is present in the document:

• Device Name: Propper Insight™ Binocular Indirect Ophthalmoscope (BIO) Kits (Models 199185 and 199285)
• Regulatory Class: II (Product Code: HLI)
• Intended Use: "Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye."
• Predicate Device: Heine OMEGA 500 binocular Indirect ophthalmoscope, LED version (K123316)
• Substantial Equivalence Basis: The Propper Insight™ BIO is deemed substantially equivalent to the predicate device because:
  • Both are designed for the same purpose.
  • Both use similar light sources (LED).
  • Both have the same indications for use.
  • Both have very similar operational principles and design.
  • The new device does not introduce new potential hazards or safety risks.
  • The device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes." This compliance serves as the primary technical validation for the device's performance and design.

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