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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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When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.

The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.

This document describes the validation of a surgical face mask. As such, the concept of "AI assistance for human readers" or "ground truth established by experts with many years of experience" is not applicable in the context of device performance testing for such simple medical devices. The evaluations are based on standardized physical and biological tests against established criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm.

The device is a qualitative, single use, reagent chemical indicator made up of a 0.20-inch square indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration. The indicator pad is affixed to one end of a 3.25 inch by 0.20-inch white opaque plastic handle.

The QwikCheck™ Chemical Indicator is a qualitative chemical indicator designed to determine if the concentration of peracetic acid (PAA) in CS Medical's TD-12 Solution is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

Here's an analysis based on the provided text:

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 test set within the "Summary of Non-Clinical Performance Data." It indicates that the performance was evaluated "in a range of concentrations below, at, and above the MRC" and that "data collection [is] ongoing" for stability studies. The provenance of the data is not specified (e.g., country of origin). The studies are non-clinical, meaning they were conducted in a laboratory setting. The data appears to be prospective in nature, as tests were performed to evaluate the device's performance under various conditions.

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

The document does not mention the use of human experts to establish ground truth for the test set. Given that this is a chemical indicator designed for objective colorimetric assessment of peracetic acid concentration, the ground truth would likely be established through precise chemical analytical methods (e.g., spectrophotometry, titration) to determine the exact PAA concentration in the prepared solutions.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned, as human interpretation and multi-reader review are not applicable to the evaluation of a chemical indicator. The device's output (color change indicating PASS/FAIL) is compared directly against the known chemical concentration.

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

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or other human-interpreted medical devices where the variability of human perception is a factor. The QwikCheck Chemical Indicator is a passive device with a direct chemical reaction indicating a result.

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

Yes, the studies conducted are standalone evaluations of the chemical indicator's performance. The "device performance" refers to the indicator's ability to accurately change color (PASS/FAIL) in response to specific PAA concentrations, without human intervention in determining the PAA concentration itself (which is the ground truth from chemical analysis). The "read time" and "blot time" mentioned in the Instructions for Use Validation refer to user interaction, but the core performance being validated is the chemical reaction of the indicator.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on known chemical concentrations of peracetic acid in TD-12 Solution. These concentrations are precisely prepared "below, at, and above the MRC" (1750 ppm). For example, a solution known to be below 1750 ppm should result in a "FAIL" indication, and a solution known to be above 1750 ppm should result in a "PASS" indication.

8. The Sample Size for the Training Set

The document does not specify a "training set" or "sample size for the training set." Chemical indicators are typically developed through chemical formulation and optimization, rather than machine learning algorithms that require distinct training sets. The studies described are performance validation studies, not training exercises.

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

Since there is no mention of a training set for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The ground truth for validating the device's accuracy would have been established through analytical chemistry methods to create solutions with verified concentrations of peracetic acid.

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The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.

The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.

The SERIM Research Corporation RAPICIDE OPA-28 Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA), the active ingredient in RAPICIDE OPA-28 Solution, is above or below its established Minimum Recommended Concentration (MRC) of 0.35%.

Here's an analysis of its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided document indicates the device must reliably indicate if the OPA concentration is above or below the MRC of 0.35%.
The clinical study demonstrated that the device met these criteria through comparative performance with a predicate device.

2. Sample Size and Data Provenance

The document does not explicitly state the exact sample size (number of test strips or OPA solution samples) used for the blind studies.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic device, it is highly likely that the studies were prospective, conducted at the manufacturer's facilities.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth. For chemical indicators like this, the "ground truth" would likely be established through analytical chemistry methods (e.g., spectrophotometry or titration) to precisely determine the OPA concentration in the test solutions, rather than human interpretation of the strips themselves as the primary ground truth.

4. Adjudication Method

The document does not describe an adjudication method. For a qualitative chemical indicator where the "ground truth" is a defined chemical concentration, judgment calls by multiple experts with an adjudication method are typically not required. The comparison is against an analytical standard.

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

No MRMC comparative effectiveness study was mentioned. This type of study is typically relevant for interpretative devices where human variability in reading results is a significant factor. For a chemical indicator, the reading is expected to be relatively straightforward (color change), reducing the need for such a complex reader study. The study focused on the performance of the device itself rather than human improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Performance" section explicitly states that "The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies." This evaluation determines the device's ability to accurately indicate the OPA concentration without human-in-the-loop assistance in the interpretation of the color change.

7. Type of Ground Truth Used

The ground truth used would be analytical determination of OPA concentration. The study involved evaluating the test strips in "OPA solutions of Rapicide OPA-28 at the MRC and above." This implies that the OPA concentrations in these solutions were precisely known through validated analytical chemistry methods, serving as the objective ground truth against which the test strip's performance was measured.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This is common for chemical indicators of this type, which are typically developed based on chemical principles rather than machine learning algorithms requiring explicit training data. The development process would involve formulation and optimization of the reagents to achieve the desired color change at the target concentration.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of machine learning, there is no corresponding ground truth establishment method described. The development of the test strip would rely on chemical formulation and empirical testing against analytically prepared OPA solutions with known concentrations.

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The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.

The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square indicator pad that has been chemically treated to detect GTA. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

Here's a breakdown of the acceptance criteria and study information for the Serim® D-CIDE GTA 1.5% Test Strip, 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:

• Sample Size: Not explicitly stated in the provided document. The document mentions "split samples blind studies" but does not give a numeric count of samples.
• Data Provenance: Not explicitly stated. There's no mention of country of origin or whether the data was retrospective or prospective.

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 method of establishing ground truth relies on the chemical reaction and visual color change of the test strip, and comparison to a predicate device, rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set:

• This information is not provided as the ground truth appears to be based on the chemical reaction and visual color change, not on subjective assessment that would require adjudication. The study involved "blind studies" and comparison to a predicate device.

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, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool. Its performance is based on a chemical reaction producing a visual color change, not on human interpretation that could be augmented by AI.

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

• Yes, in essence, a standalone performance was done. The device itself, a chemical test strip, operates independently to produce a visual result based on the glutaraldehyde concentration. The "performance" described is the inherent function of the test strip (a chemical reaction) and its visual output, without a human "in the loop" for interpretation beyond simply observing the color change.

7. The Type of Ground Truth Used:

• The ground truth is established by the chemical concentration of glutaraldehyde in the solutions being tested. The device is designed to visually indicate whether this concentration is above or at/below the MEC of 1.5%, based on a specific chemical reaction. The validation relies on comparing this visual indication against the known concentration of glutaraldehyde and against the performance of a predicate device.

8. The Sample Size for the Training Set:

• This information is not provided in the document. The device is a chemical indicator, not a machine learning algorithm that requires a training set in the typical sense.

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

• This information is not applicable/provided. As mentioned, the device is a chemical indicator. Its development and validation likely involved chemical formulations and testing to ensure the desired color change reaction at specific glutaraldehyde concentrations, rather than a "training set" with established ground truth as understood in AI/machine learning contexts.

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The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.

The device is a qualitative, single use, reagent test strip made up of a 0.40-inch square reagent pad that has been chemically treated to detect glutaraldehyde in CIDEXPLUS 28 Day solutions. The pad is affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the Serim® DISINTEK™ GTA 2.1%. Instead, it refers to performance in comparison to a predicate device. The core functionality is to indicate whether the glutaraldehyde concentration is above or below the Minimum Effective Concentration (MEC) of 2.1%. The description focuses on the qualitative visual response.

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

The document states: "The performance of the Serim Disintek GTA 2.1% Test Strips was evaluated in split samples blind studies..."

• Sample Size: The exact sample size for the test set is not specified in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. The study was a "blind study," which implies it was conducted to objectively assess the device's performance. It is a prospective study, as it's an evaluation of the device's performance under controlled conditions.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the "split samples blind studies". The ground truth appears to be based on the actual glutaraldehyde concentration (e.g., above 2.1%, at/approaching 2.1%, approaching 1.5%) rather than expert interpretation of the test strips.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (like 2+1, 3+1, none) for the test set. Given the nature of the device (a chemical indicator with a visual color change), the "ground truth" seems to be determined by the objective chemical concentration rather than requiring expert adjudication of reader interpretations, although visual interpretation is involved.

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

• Was an MRMC study done? No, not in the sense of comparing human readers' performance with and without AI assistance. This device is a manual chemical indicator, not an AI-assisted diagnostic tool for Human-in-the-Loop scenarios. The study compared the new device's performance against a predicate device.
• Effect Size: Not applicable as it's not an AI-assisted MRMC study.

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

This question is not directly applicable to the device as presented. The device is a "qualitative, single use, reagent test strip" that relies on a visual interpretation by a human observer. There is no "algorithm only" performance because the device itself is a passive chemical indicator that requires human observation for its intended use. The performance evaluation would inherently include the human interpretation component, or at least a comparison against a known chemical concentration.

7. The Type of Ground Truth Used

The ground truth used for the study appears to be the actual glutaraldehyde concentration in the CIDEXPLUS 28 Day solutions. The device is designed to indicate whether this concentration is "above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution." This implies that the solutions used in the "split samples blind studies" had known glutaraldehyde concentrations.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components. Therefore, a sample size for a training set is not applicable. The device relies on chemical reactions, not on data-driven models that require training.

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

As there is no training set for this chemical indicator device, this question is not applicable.

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The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.

The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Metricide OPA Plus Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.

The Serim® DISINTEK™ OPA Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA) in Metricide OPA Plus Solution is above or below its minimum effective concentration (MEC) of 0.3%.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device, specifically the Metricide OPA Plus Solution Test Strip, by accurately indicating OPA concentration relative to the 0.3% MEC.

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

• Sample Size: The document does not explicitly state the numerical sample size used for the test set. It mentions "split samples blind studies" but provides no specific numbers for the samples tested.
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission to the US FDA, it is highly likely that the data was generated in the United States, but this is not explicitly confirmed. The studies appear to be prospective in nature, as they involve actively evaluating the performance of the new device in comparison to a predicate.

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 method for establishing ground truth for the test set is implied by the comparison to a predicate device and chemical reactions, rather than expert interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. The nature of a chemical indicator test, where the result is a color change based on a chemical reaction, typically does not involve human adjudication in the same way an imaging diagnostic might. The output is a direct chemical reading.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists in the reading process. The Serim® DISINTEK™ OPA Test Strip is a chemical indicator that produces a direct, objective result (color change), not a complex interpretation task for human readers.
• Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Was it done? Yes, in essence, the performance evaluation described is a standalone study of the device. The "split samples blind studies" evaluated the performance of the Serim DISINTEK OPA Test Strips on their own merits and then compared the results directly to the predicate device. The device's mechanism is a chemical reaction leading to a direct color change, which is an inherent "algorithm" of the test strip itself. The outcome is not subject to human interpretation in the same way as an imaging algorithm might be reviewed by a human.

7. Type of Ground Truth Used

The ground truth used is based on chemical concentration levels of OPA relative to the 0.3% MEC. This is established by:

• The known chemical properties and reactions designed into the test strip.
• Comparison to the performance of an already legally marketed and accepted predicate device (Metricide OPA Plus Solution Test Strips) which also relies on chemical determination of OPA concentration.
• The chemical principle: "A chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color." This defines the objective ground truth against which the strip's response is measured.

8. Sample Size for the Training Set

This information is not provided. As this is a chemical indicator and not a machine learning or AI-driven device in the modern sense (which typically requires large training sets), the concept of a "training set" for an algorithm isn't directly applicable in the same way. The device's "training" would be through its chemical formulation and manufacturing tolerances, which are established through lab development and quality control, not typically a large data-driven training set.

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

Not applicable in the context of a "training set" for a traditional algorithm. The "ground truth" for the device's design and chemical formulation would have been established through:

• Understanding the specific chemical reactions of OPA.
• Titration or analytical chemistry methods to precisely determine OPA concentrations at and around the 0.3% MEC.
• Empirical testing during product development to refine the chemical composition of the test strip to achieve the desired sensitivity and specificity for the color change at the MEC threshold.

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The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.

The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Cidex OPA Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.

The provided text describes the Serim DISINTEK OPA Test Strips and the study conducted to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly defined by the performance of the predicate device, the Cidex OPA Solution Test Strip, and the ability to accurately indicate the OPA concentration above or below the Minimum Effective Concentration (MEC). The device's performance is reported in comparison to this predicate.

Acceptance Criteria & Reported Device Performance for Serim DISINTEK OPA Test Strips

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

• Sample Size for Test Set: The document states "split samples blind studies" were used, but it does not specify the exact sample size used for the test set.
• Data Provenance: Not explicitly stated, but typical for device submissions in the US, the studies would likely be conducted in the country of origin of the submitter (Serim Research Corporation, Elkhart IN, USA). The study is described as performance evaluation, implying it was prospective in nature, as new data was generated using the device.

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

The document does not mention the use of "experts" in establishing ground truth in the context of human readers or medical professionals for this type of chemical indicator. The ground truth for chemical concentration is typically established by analytical chemistry methods rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For a chemical indicator, "adjudication" in the sense of reconciling differing expert opinions would not typically apply. The "ground truth" for OPA concentration would be determined by quantitative chemical analysis.

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, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

The device itself is a passive chemical indicator. Its performance is inherent to its chemical reaction properties. While human interpretation of the color change is necessary, the "test strip" itself acts as a "standalone" indicator in the sense that its chemical reaction and color formation occur independently of human judgment. The study evaluated the device's performance directly by comparing its indications to those of the predicate device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this chemical indicator would be the actual chemical concentration of ortho-phthalaldehyde (OPA) in the Cidex OPA Solution, determined by a validated analytical method (e.g., spectrophotometry, titration, or other quantitative chemical analysis). The device's color change is then compared against this known OPA concentration to determine its accuracy in indicating above or below the MEC of 0.3%.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a chemical indicator and not a machine learning or AI model. The concept of training data does not apply here.

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

As there is no training set for this chemical indicator, this question is not applicable.

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SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.

The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

This document is a 510(k) summary for the SERIM® HiSENSE ULTRA 0.1™ Test for Total Chlorine. It describes the device, its intended use, technological characteristics, and performance evaluation.

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 Data Provenance

The document does not explicitly state a specific numerical sample size for the test set. It mentions: "The performance of the Serim HiSENSE ULTRA 0.1 Test Strips were evaluated using water samples in which either sodium hypochlorite or chloramines were added to give a range of total chlorine (free chlorine/chloramines) levels."

• Sample Size: Not explicitly stated as a number of samples. The evaluation used "water samples."
• Data Provenance: The water samples were prepared by adding sodium hypochlorite or chloramines to achieve varying total chlorine levels. While the country of origin isn't specified, it's implied to be an in-house laboratory evaluation based on the nature of the test. It is a prospective evaluation, as samples were prepared for the purpose of testing the device.

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 ground truth for the prepared water samples would typically be established by precise chemical measurements (e.g., using a reference method or analytical chemistry techniques) rather than human experts interpreting results.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a semi-quantitative chemical test strip, the adjudication method would likely involve comparing the color change on the strip to a color chart provided with the device, and subsequently comparing that reading to the known concentration of the prepared water sample.

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 manual chemical test strip, not an AI-assisted diagnostic tool.

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

Not applicable. This device requires human interpretation of the color change on the test strip against a color chart. It is not an automated algorithm.

7. The Type of Ground Truth Used

The ground truth for the test set was established by prepared water samples with known concentrations of total chlorine. These known concentrations would have been determined through precise chemical methods, making it an analytical truth.

8. The Sample Size for the Training Set

This information is not provided in the document. As a chemical test strip, it's unlikely to have a "training set" in the sense of machine learning algorithms. The design and calibration of the test strip's chemical formulation and color chart would be based on chemical principles and experimental validation, but the term "training set" is not applicable here.

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

Not applicable. See point 8. The "ground truth" for developing such a device would reside in the chemical reactions and the correlation of color intensity to chlorine concentration, established through laboratory experiments and chemical analysis during the product's R&D phase.

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The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.

The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square purple reagent pad that has been chemically treated to detect the active ingredient in the Steris 20™ Sterilant® when used in the STERIS SYSTEM 1® Processor™. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

The Serim* Peracetic Acid Chemical Indicator is configured as a paper pad on a plastic strip support. A dve in the chemical indicator pad is oxidized (bleached) by the use solution. The extent of bleaching indicates whether a sufficient concentration active agent (peracetic acid) was present. At the end of the processing evele the user compares the reacted indicator to a color chart composed of two color blocks. The "START" color block is similar to the unreacted indicator strip. The =COMPLETE color block is similar to an indicator strip that has been exposed to peracetic acid at or above a concentration of 1500 ppm.

The provided text is a 510(k) Premarket Notification for the Serim® Peracetic Acid Chemical Indicator. This document focuses on establishing substantial equivalence to a previously cleared device, not on presenting a standalone study with detailed acceptance criteria and performance data as one would expect for a new, non-equivalent device or an AI/software as a medical device (SaMD).

Therefore, many of the requested points cannot be directly addressed from the provided text because the device, a chemical indicator, is not an AI/Software device, nor is the document an MRMC or standalone study report. It's a regulatory submission for a physical device.

However, I can extract information relevant to the intent of the questions where possible, and clearly state when information is not available due to the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

The submission declares substantial equivalence to the STERIS PROCESS™ Chemical Monitoring Strips (K921559). The "acceptance criteria" for this submission appear to be the demonstrated identical nature and functionality to the predicate device.

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

Not applicable. This is a 510(k) for a physical chemical indicator, not a study involving a test set of data (like medical images or clinical records). The claim is about manufacturing and functional identity to a predicate device.

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

Not applicable. No "ground truth" as typically understood in a software or AI device study is established for a test set in this 510(k) submission. The performance relies on the chemical reaction and color change.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a chemical indicator, not an AI or software device, and no MRMC study is mentioned or relevant to this type of submission.

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

The device is a standalone chemical indicator that produces a visual result. It requires human interpretation to compare the reacted strip to a color chart. There is no "algorithm only" component. The performance discussed is the chemical reaction itself, not a digital algorithm.

7. The type of ground truth used

The "ground truth" for this chemical indicator's functionality is the known chemical concentration of peracetic acid. The device is designed to visually indicate if this concentration is at or above a specific threshold (1500 ppm).

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not an AI or machine learning model that requires a training set.

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

Not applicable. No training set is used for this device.

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