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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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The Celerity™ 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® Technology

When used in conjunction with the Celerity™ HP Incubator or the Celerity™ Incubator, the Celerity™ 20 HP BI provides a fluorescent result within 20 minutes.

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity™ Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

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Terragene® Bionova® BT20 Biological Indicator is a Self-Contained Biological Indicator (SCBI) intended for routine monitoring of the efficacy of the following steam sterilization processes:

• Gravity-displacement Steam Sterilization Cycles

• 121 °C, 30 minutes
• 132 °C, 25 minutes
• 132 °C, 15 minutes
• 132 °C, 10 minutes
• 134/135 °C, 10 minutes

• Vacuum-assisted Steam Sterilization Cycles

• 121 °C, 20 minutes
• 132 °C, 4 minutes
• 134/135 °C, 3 minutes

Terragene® Bionova® BT20 provides a final result after a 24 hour incubation at 60 ± 2 °C.

Terragene® Bionova® BT20 Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a filter paper spore carrier inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus ATCC® 7953 spores and a glass ampoule containing purple culture medium, enclosed with a plastic colored cap and a barrier permeable to steam. The culture medium contains a pH indicator that changes color upon acidification by the metabolism of living spores. On each BT20 Biological Indicator there is a propylene label printed with a chemical process indicator that changes from pink to brown when exposed to steam.

Final results: 24-hour readout after incubation at 60 °C. If the sterilization process was successful, culture medium will remain purple. If sterilization was not successful, culture medium will turn to yellow during incubation, thus indicating the presence of live G. stearothermophilus spores.

This document describes the acceptance criteria and the study proving the Terragene® Bionova® BT20 Biological Indicator meets these criteria.

It's important to note that this device is a Biological Indicator for sterilization, not an Artificial Intelligence (AI) or medical imaging device. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth establishment for AI training, etc.) is not applicable. The information provided focuses on the rigorous testing required for biological indicators to demonstrate their efficacy in monitoring sterilization processes.

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

The following table summarizes the acceptance criteria and the "Results" कॉलम में "Passed" यह बताता है कि डिवाइस ने उन सभी मापदंडों को सफलतापूर्वक पूरा किया है।

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

The document does not explicitly state the specific numerical sample sizes for each test in terms of "number of devices tested." However, it consistently refers to testing "three batches analyzed" for critical tests like Viable Spore Population Assay and Reduced Incubation Time (RIT) Test. This suggests a minimum sample size of three batches of the biological indicators for key performance evaluations.

• Data Provenance: The studies were non-clinical performance tests conducted by the manufacturer, Terragene S.A., based in Alvear, Santa Fe, Argentina. The studies are by nature prospective, as they involve manufacturing the device and then subjecting it to controlled tests to demonstrate performance against established standards.

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 as the device is a biological indicator for sterilization monitoring, not an AI or medical imaging device that relies on expert human interpretation for ground truth. The "ground truth" for a biological indicator is defined by the objective outcome of sterilization cycles (e.g., whether spores are killed or grow) and the established scientific standards for spore population, resistance, and growth media. These are measured objectively in a laboratory setting.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI evaluations where human experts are making subjective assessments that need to be reconciled. For a biological indicator, the results are objective (e.g., color change, spore growth/no growth, D-value calculation) based on laboratory protocols defined by ISO standards and FDA guidance.

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

This information is not applicable. This is a biological indicator designed to monitor sterilization, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.

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

This information is not applicable. The device is a physical biological indicator, not an algorithm. Its performance is evaluated in a standalone manner as a biological entity in controlled sterilization and incubation environments, without human intervention during the "reading" phase (i.e., the color change is observed visually or automatically after incubation, it's not a human performing a complex interpretation). The "algorithm" in this context is the biological response of the spores.

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

The ground truth for a biological indicator is primarily established through:

• Microbiological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions, confirmed by observed growth or no growth in a suitable culture medium.
• Physical Parameters: Precisely controlled and measured physical parameters of the sterilization cycles (temperature, time, pressure) that are known to either kill or allow survival of the specific spore population.
• Referenced Standards: The "ground truth" is also defined by the detailed specifications and methodologies outlined in international standards such as ISO 11138-1:2017, ISO 11138-3:2017, and ISO 11138-8:2021, and FDA Guidance documents for biological indicators. These standards define the acceptable D-values, spore populations, survival times, and kill times under specified conditions.

Essentially, the ground truth is based on established scientific and microbiological principles and standardized test methodologies rather than subjective expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as the device is a biological indicator and does not involve AI or machine learning that requires a "training set" of data.

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

This information is not applicable for the same reason as above.

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The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.

(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.

(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.

The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.

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

Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

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

• Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
• Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
• Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
• Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
• Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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Celerity 5 HP Biological Indicator:
The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack:
The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non-Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 5 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 5 HP Challenge Pack
The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to the devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

Celerity 20 HP BI
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to these devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

The provided text describes premarket notification for biological indicators and doesn't involve an AI/ML powered medical device. Therefore, many of the requested criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study" or "number of experts used to establish ground truth", which are specific to AI/ML powered devices, are not applicable here.

However, I can extract information related to the acceptance criteria and the study proving the device meets those criteria, as much as applicable for a non-AI medical device.

Device: Celerity 5 HP Biological Indicator (LCB052) & Challenge Pack (LCB059), and Celerity 20 HP Biological Indicator (LCB044) & Challenge Pack (LCB045)

Type of Device: Sterilization Process Indicator (Biological Indicator - BI). These devices contain a specific type of spore (Geobacillus stearothermophilus) and media to confirm the effectiveness of a sterilization process. A positive result (fluorescent signal) indicates sterilization failure, while a negative result indicates successful sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and results are provided for two distinct product lines: Celerity 5 HP and Celerity 20 HP. Note that the "Result" for all tests is simply "PASS", indicating that the criteria were met.

For Celerity 5 HP Biological Indicator and Challenge Pack:

For Celerity 20 HP Biological Indicator and Challenge Pack:

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

The document does not explicitly state the numerical sample size (e.g., number of BIs or challenge packs) used for each specific test (Reduced Incubation Time, Simulated Use, Cap Media, Stability testing). It refers to "All BI lots" for Reduced Incubation Time and "All processed BIs" for Simulated Use, and implicitly "BIs" for Stability Testing. This suggests a statistically relevant number of units from manufactured lots were tested.

• Data Provenance: The document does not specify the country of origin of the data. Given the "U.S. Food & Drug Administration" letterhead and the manufacturer's address in Ohio, USA, it is highly likely that the testing was conducted in the US.
• Retrospective or Prospective: The testing appears to be prospective as it's a pre-market submission to demonstrate the device meets performance criteria for clearance. Stability testing also inherently involves prospective observation over time.

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

This concept is not applicable to this type of device. The "ground truth" for a biological indicator is determined by the biological and chemical reactions themselves (i.e., presence or absence of viable spores, or a color change in the chemical indicator), not by human expert interpretation of images or data. The determination of "sterile" or "non-sterile" from a biological indicator is a direct, objective measurement.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the results of biological indicators are typically objective and determined by the physical/chemical properties and reactions, not by subjective human interpretation requiring adjudication.

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/ML device nor one that involves human "readers" interpreting medical images or data.

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

Not applicable. This is a physical, biological and chemical indicator device, not a software algorithm. The "Celerity Incubator" is an accessory that reads the fluorescent signal, it is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for these devices is based on biological viability (presence or absence of viable Geobacillus stearothermophilus spores) for the biological indicator and chemical reaction (color change) for the chemical indicator, validated against recognized sterilization parameters (e.g., D-value, Survival Time, Kill Time). This is a direct measure of the effectiveness of the sterilization process.

8. The Sample Size for the Training Set

Not applicable. These are not AI/ML devices that require training sets. The "training" of these devices (i.e., their manufacturing and design) is based on established microbiological and sterilization science.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of these biological indicators relies on their inherent design and manufacturing quality, ensuring the spores exhibit the specified resistance characteristics and the media accurately detects their viability. This is established through rigorous quality control and adherence to relevant standards for biological indicators.

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The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.

The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.

Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) Clearance Letter for DISINTEK™ PA Test Strips:

Acceptance Criteria and Device Performance for DISINTEK™ PA Test Strips

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 numerical sample sizes (e.g., number of test strips, unique disinfectant solutions tested, or replicates) used for each test set within the "Dynamic Range," "Instructions for Use Validation," "Closed Bottle Shelf-Life Stability," "Open Bottle Use-Life Stability," "Analytic Specificity – Bioburden," or "Analytic Specificity – Other Disinfectants" studies.

For Comparative Sensitivity and Specificity, the document also does not specify the numerical sample size.

Data Provenance: The studies were conducted by Serim Research Corporation themselves, implying the data is generated internally from their own testing facilities. The data appears to be prospective, as it describes the testing performed on the new DISINTEK™ PA Test Strips to demonstrate their performance against defined criteria. No information regarding country of origin of the data beyond "Serim Research Corporation" is provided, but as an FDA submission, the testing would likely adhere to US regulatory standards.

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

This information is not provided in the document. For chemical indicators like this, "ground truth" typically refers to the analytically determined concentration of PAA in the test solutions. This would be established by validated chemical testing methods (e.g., titration or spectroscopy) rather than expert consensus on visual interpretation. The document implies that the "ground truth" for FAIL/PASS results is based on a known PAA concentration (below/at 850 ppm MRC as FAIL, above as PASS), which would be determined analytically.

4. Adjudication Method for the Test Set

The document describes chemical indicator functionality (color change) and the interpretation of those changes (PASS/FAIL based on visual comparison to color blocks or a "solid black color" for the predicate). There is no indication of an adjudication method involving multiple human readers for interpreting the results of the DISINTEK™ PA Test Strips. The expectation is that the visual interpretation by a single user, following the provided instructions and color chart, is sufficient.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is usually conducted for imaging diagnostics or devices where human interpretation directly impacts effectiveness and can be improved by AI assistance. This device is a chemical indicator with a direct visual interpretation, not a diagnostic imaging AI system.

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

Yes, the studies described are essentially standalone in terms of the device's chemical performance. The studies evaluate the chemical indicator's ability to accurately reflect the PAA concentration, independent of human variability in reading.

However, the "Instructions for Use Validation" section does implicitly involve human interaction, as it validates the device when used as directed by a human with a specific dip and read time. The "performance" being measured (100% FAIL below MRC, 100% PASS above MRC) is the device's inherent chemical reaction, and the human's role is to correctly perform the test and interpret the color chart. So, while it's not an algorithm only in the AI sense, the core data is about the chemical functionality.

7. Type of Ground Truth Used

The ground truth used is based on analytically determined peracetic acid (PAA) concentrations in the RAPICIDE™ PA HLD solutions. Solutions were prepared with known concentrations below, at, and above the 850 ppm PAA Minimum Recommended Concentration (MRC). The "FAIL" result would be correlated with PAA concentrations ≤ 850 ppm, and the "PASS" result with PAA concentrations > 850 ppm.

8. Sample Size for the Training Set

This information is not applicable/not provided. The DISINTEK™ PA Test Strips are a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm that learns from data.

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

This information is not applicable/not provided for the reasons stated in point 8.

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The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.

Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.

The provided FDA 510(k) clearance letter pertains to a chemical indicator device, "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118," not an AI/ML-enabled medical device. Therefore, the information regarding the acceptance criteria and study proving its performance is focused on the chemical and physical properties of the test strips, rather than AI model performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment relevant to AI/ML devices.

Based on the document, I can extract the following information relevant to the device's acceptance criteria and studies:

Device Description and Intended Use:

The Rapicide PA High-Level Disinfection Test Strips are chemical indicators used after the disinfection cycle to verify that the RAPICIDE™ PA High-Level Disinfectant solution has met the Minimum Recommended Concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning solid black when exposed to solutions at concentrations of 1100 ppm ± 20 ppm PAA. A "failure" (solution at or below MRC) is indicated if the pad turns dark grey, blue grey, violet grey, light grey, or white (no color change).

Here's the breakdown of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information from the 510(k) Summary)

The provided document is a 510(k) clearance letter and an abbreviated 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, raw data, or comprehensive statistical analyses that would be found in a full study report or clinical trial documentation. Therefore, many of the requested details for AI/ML device studies (sample size, data provenance, expert adjudication, MRMC studies, training set details) are not applicable or not provided for this type of chemical indicator device.

Here's a breakdown of the requested information based on the provided text:

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

   • Sample Size: Not explicitly stated in the provided document. The 510(k) summary states that "Testing to assess and demonstrate performance of the subject device is summarized below," listing categories like "Dynamic Range," "Comparative Sensitivity and Specificity," etc., and concluding they "Met Acceptance Criteria." However, the exact number of test strips or solution samples used for each test is not disclosed.
   • Data Provenance: Not specified. It can be inferred that the testing was conducted internally by STERIS Corporation, likely in a laboratory setting, to evaluate the chemical performance of the test strips. Retrospective or prospective nature is not mentioned for this type of chemical performance testing.

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

   • Not Applicable / Not Provided: For a chemical indicator device, "ground truth" is typically established by precisely formulated chemical solutions (e.g., 850ppm PAA, 1100ppm PAA ± 20ppm PAA) with known concentrations, verified by analytical chemistry methods, rather than by human expert consensus or annotations as would be the case for medical imaging AI. The document does not mention the use of human experts for establishing ground truth.

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

   • Not Applicable / None: Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human expert annotations for complex data (e.g., medical images). For a chemical indicator, the output (color change) is objective and directly correlated with the chemical concentration. The "reading" of the strip is a visual interpretation of a chemical reaction against a defined color standard (solid black for pass, various greys for fail). Discrepancies would likely be addressed through re-testing or instrument calibration, not expert 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:

   • Not Applicable: MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation. This device is a chemical indicator test strip, not an AI-assisted diagnostic tool.

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

   • Not Applicable: This device is a physical chemical strip, not a software algorithm. Its performance is inherent in its chemical design.

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

   • Known Chemical Concentrations: The ground truth for this device is established by precisely prepared chemical solutions with known, verified concentrations of peracetic acid (e.g., 850ppm MRC, 1100ppm pass threshold). This is a direct physical or chemical measurement, not dependent on expert consensus, pathology, or outcomes data.

7. 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. The "design" is based on chemistry and materials science, not data-driven learning.

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

   • Not Applicable: As there is no "training set" for a chemical indicator, this question is irrelevant. The "design" and "calibration" involve chemical engineering and materials science, where the components are selected and optimized to react predictably to specific chemical concentrations.

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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Here's an analysis of the provided FDA 510(k) clearance letter, focusing on the acceptance criteria and the study proving the device meets them:

The VERIFY STEAM Integrating Indicator (K243876) is a chemical indicator designed to monitor steam sterilization cycles. It is intended to be placed within containment devices (packs, pouches, etc.) during sterilization to independently verify that critical parameters have been met. The device is considered to "pass" if a dark bar on the indicator enters the "ACCEPT (OK)" window.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical testing performed to evaluate the performance of the VERIFY STEAM Integrating Indicator and demonstrate its substantial equivalence to a predicate device (K213412).

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

• The document does not specify the exact sample sizes (number of indicators) used for each individual test (Stated Value, Simulated Use, Stability, Comparison with Biological Indicator).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission for a medical device, it is highly likely that these were prospective, laboratory-based studies conducted by the manufacturer (STERIS Corporation, Franklin Park, IL, USA) to evaluate the device's performance under controlled conditions.

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

• This device is a chemical indicator that produces a visual change (dark bar entering an "ACCEPT (OK)" window) based on exposure to sterilization parameters. The "ground truth" for these tests is established by the controlled sterilization cycle conditions (temperature, time, presence of steam) and the objective physical change of the indicator, rather than subjective expert interpretation.
• Therefore, no human experts were used to establish the ground truth for the test set in the way radiologists or pathologists would interpret an image. The performance is assessed against defined physical and chemical criteria.

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

• As the "ground truth" is determined by objective physical and chemical changes under controlled conditions, and the outcome (pass/fail) is a direct observation of the indicator's state, no adjudication method involving human experts was necessary for the test set.

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 type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VERIFY STEAM Integrating Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its primary function is to react chemically, not to be "read" in a complex interpretive sense by multiple human readers.

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

• This question is not applicable in the context of a chemical indicator. The device is entirely standalone in its function – it reacts chemically without any human intervention or an algorithm. Its "performance" is its physical color change, which is then observed by a human. There is no separate "algorithm" to evaluate.

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

• The ground truth for these tests is based on objective physical and chemical properties and predefined standards. Specifically:
  • Controlled Sterilization Parameters: The cycles are run at precisely defined temperatures and times, and the presence of steam is controlled. The "truth" is whether these parameters were met or not.
  • ANSI/AAMI/ISO 11140-1:2014: This international standard defines the performance requirements for chemical indicators, providing the objective benchmarks against which the device is evaluated.
  • Biological Indicator Inactivation: For comparison testing, the inactivation of a biological indicator (a highly resistant microorganism) serves as an objective "gold standard" for sterilization efficacy.

7. The sample size for the training set:

• The document does not mention a "training set" in the context of device development. This concept is typically associated with machine learning or AI models. For a chemical indicator, the "development" involves chemical formulation, material science, and engineering to achieve the desired reaction kinetics and visual endpoint. There isn't a "training set" in the computational sense.

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

• As there is no "training set" in the conventional sense for this type of device, this question is not applicable. The development of such an indicator would involve extensive research and development in chemistry and material science, where performance is iteratively optimized against the physical/chemical principles of sterilization and the requirements of relevant standards.

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The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.

The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called "Sterilization Package/Reel." This document focuses on the substantial equivalence of the device to existing predicate devices, primarily through non-clinical bench testing and comparisons of technological characteristics.

The information you requested, relating to acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD)'s performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided text.

The document discusses validation of sterilization processes (ISO 11135, ISO 17665-1), material compatibility, package integrity, and biocompatibility, which are standard tests for physical sterilization packaging, not for AI device performance.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
• · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).

Furthermore, there are 3 thicknesses for health care workers to choose from as follows:

• · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m
• Pouch of Combination B: Medical grade paper 60g+laminated film 52um
• · Pouch of Combination C: Medical grade paper 70g+laminated film 52um

The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO).

The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization.

The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization.

The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas.

The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows:

• Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M
• Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M
• · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M

The provided text is a 510(k) summary for the Medicom Sterilization Pouch and Reel. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria as would be done for a novel AI/software medical device.

Therefore, much of the requested information (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, AI effect size, training set details) is not applicable to this type of device submission and is not present in the document.

However, I can extract the acceptance criteria and reported performance for the physical and chemical properties of the Medicom Sterilization Pouch and Reel, as these are the relevant performance metrics for this specific device.

Based on the provided document, here's an analysis:

Device: Medicom Sterilization Pouch and Reel (FRG, JOJ - Sterilization Wrap)

1. Table of acceptance criteria and the reported device performance:

The document provides extensive tables (Table 5-4 and Table 5-5) detailing the tests performed, the standards followed, the acceptance criteria, and the results ("Pass"). I will consolidate and present these.

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

• Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, and biological test. It only states that the "results of the Medicom Sterilization Pouch and Reel validation studies demonstrate that the sterilization pouches perform as intended."
• Data Provenance: Not explicitly stated regarding the origin of the test samples (e.g., country of manufacture). The studies appear to be prospective validation tests conducted by the manufacturer to demonstrate performance against established standards.

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. The "ground truth" for this device (sterilization pouches and reels) is established by adherence to recognized international standards (e.g., ISO, ASTM, AAMI) for physical, chemical, and biological performance. These standards define the test methods and acceptance criteria. There is no subjective human interpretation or "expert consensus" on ground truth in the way there would be for an AI diagnostic device evaluating medical images.

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

• Not applicable. Adjudication methods like "2+1" are relevant for clinical studies involving human readers and subjective interpretations, especially in AI-assisted diagnosis. For physical product testing conforming to specific standards, the results are typically objectively measured and evaluated against predefined thresholds.

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 sterilization pouch and reel, not an AI or imaging device that would involve human readers or MRMC studies.

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

• Not applicable. This is not a software algorithm or AI device.

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

• The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized international standards (e.g., successful microbial inactivation as per SAL 10^-6, specific tensile strengths, lack of leaks, defined color changes for chemical indicators, biocompatibility profiles). These are established through laboratory testing following validated protocols, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires 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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