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The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chloramines plus free chlorine) in feed water used to prepare dialysate in hemodialysis systems.

The CM130 is a component of the complete water treatment system for hemodialysis and does not treat or alter the water used in dialysate. The CM130 instrument's automated monitoring records total chlorine values in feed water at intervals between 5 and 20 minutes.

The Hach CM130 Chlorine Monitor is a microprocessor-controlled analyzer used to monitor the chlorine content of water which is used to prepare dialysate for hemodialysis. The monitor is mounted in the water room in a location that allows sampling of feed water between the primary (scrubbing) and secondary (polishing) carbon tanks. Water that flows into the CM130 exits the device to a drain. The water samples, once tested, are also discarded to a drain.

The monitor measures and displays total chlorine (free chlorine and combined chloramines) as Cl2, ranging from 0.03 to 0.20 mg/L.

The CM130 Chlorine Monitor employs a DPD Colorimetric Method for the detection of total chlorine. The analyzer introduces N,N-Diethyl-p-phenylenediamine (DPD) indicator with potassium iodide and a buffer to the water sample under test. The indicator and buffer are allowed to react with the chlorine and chloramines present in the water. The reaction results in a dye which forms a red color in the water sample. The intensity of the red color is proportional to the total chlorine concentration. It is measured photometrically and the results are automatically recorded and displayed.

The Remote Indicator (RI) is a subsystem that is mounted in the patient treatment area, typically near the ceiling, so that it can be easily seen. Its primary function is to communicate the status of the chlorine concentration of the feed water and the status of the analyzer to the staff while they are working in the patient treatment room.

The CM130 Chlorine Monitor and the Remote Indicator will each provide both an audible and a visual signal.

The provided text describes the HACH CM130 Chlorine Monitor, a device intended to automatically monitor total chlorine levels in feed water for hemodialysis systems. The document is a 510(k) premarket notification summary submitted to the FDA.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

Note: This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than outright clinical efficacy studies. Therefore, many of the typical acceptance criteria for AI/ML medical devices (such as sensitivity, specificity, PPV, NPV) and the detailed study elements like MRMC studies, large-scale ground truth establishment by multiple experts, and specific training set details, are not directly applicable or explicitly stated in this type of submission for this particular device. The focus here is on analytical performance and safety.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the analytical and safety performance of the device, rather than diagnostic accuracy in a clinical context.

Study Details Proving Device Meets Acceptance Criteria

The studies conducted are primarily non-clinical performance, analytical, and safety validations.

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

   • Test Set Sample Size: Not explicitly stated in terms of a specific number of samples for each test (e.g., how many water samples for bias, how many for repeatability). The document mentions "same solutions and test setups" were used for the CM130 and the predicate device.
   • Data Provenance: The studies were "Non-clinical testing" conducted by Hach Company. The location of the testing or the origin of the solutions is not specified, but it implies laboratory-based or simulated environment testing rather than clinical patient data. The nature is prospective in the sense that the device was actively tested under controlled conditions.

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

   • This is not applicable in the typical sense for this device. The "ground truth" for chemical measurements (total chlorine) was established by a reference method for independent verification of "true" measurement values, not by human expert interpretation like in image analysis. Humans were involved in establishing the "ground truth" for human factors testing (representative users), but their qualifications are not specified beyond being "representative users" in target groups (hemodialysis professionals).

3. Adjudication Method for the Test Set:

   • Not applicable as the primary tests are quantitative measurements against a reference method or engineering standards, not subjective interpretations. Human factors testing involved observation and subjective/objective data collection, but no explicit adjudication method (e.g., 2+1 consensus) is described.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic performance. The CM130 Chlorine Monitor is a chemical monitoring device, not an imaging diagnostic device.

5. Standalone (Algorithm-Only) Performance:

   • Yes, the core of the performance testing (bias, repeatability, reproducibility, interference) assessed the standalone analytical performance of the CM130 Chlorine Monitor. The "algorithm" here refers to the instrument's measurement and display capabilities. The comparison was made against a "reference method" and the predicate device.

6. Type of Ground Truth Used:

   • Reference Method: For accuracy (bias) testing, a "reference method used to independently verify the 'true' measurement" of total chlorine was utilized. This is equivalent to a highly accurate laboratory standard or gold standard measurement.
   • Engineering Standards: For electrical safety, software validation, and alarm testing, the ground truth was defined by compliance with specific, recognized engineering and performance standards (e.g., IEC61326-1, IEC61010-1, CLSI EP12-A2).
   • Usability Objectives: For human factors testing, the "ground truth" was the ability of representative users to safely and effectively use the device, as assessed against predefined usability objectives and observed performance.

7. Sample Size for the Training Set:

   • Not Applicable / Not Explicitly Stated. The CM130 is not described as an AI/ML device that requires a "training set" in the sense of supervised learning from data. It's a deterministic chemical analyzer. Its "calibration" or internal parameters would be set through engineering and testing, not by training on a large dataset in the AI sense. Software verification and validation refer to traditional software engineering processes, not machine learning model training.

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

   • Not Applicable. Since there isn't a "training set" for an AI/ML model as described in the typical context, this question does not apply. The device's operational parameters would be established through manufacturer specifications, calibration procedures, and adherence to design control processes.

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The Opaciden OPA Solution Test Strips are a concentration monitor dedicated for use in The Opaciden Of A Solition Tool Derpo de oblions with a minimum recommended ortho-pintlanadeliyate-containing genixo. A Solution Test Strips are dedicated for use with the Ciden Opaciden OPA Solution.

The Opaciden OPA Solution Test Strip is a white polystyrene strip. of dimension 3.25 by 0.2 inch, with a 0.2 by 0.2 inch square yellow indicator pad at one end. It is intended for use exclusively with Opaciden OPA Germicide solutions to determine the germicide concentrations. The reagent pad is immersed in the sample and removed after 2 seconds. Excess sample is shaken off the pad and the strip is kept horizontal for 60 seconds. The chemical reagents in the indicator pad causes the pad to change color from yellow to magenta in OPA solutions with an ortho-phthalaldehyde concentration greater than the MRC of 0.3% OPA.

Here's an analysis of the provided text regarding the Opaciden OPA Solution Test Strips, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state a specific numerical sample size for the test set. It mentions "testing indicators in germicide solutions containing 0.3% and 0.4% ortho-phthalaldehyde." This implies a set of test strips were used in these two concentration levels. The exact number of test strips used at each concentration is not provided.
• Data Provenance: The data appears to be from a prospective study conducted by the Hach Company for their 510(k) submission. The country of origin is implicitly the U.S.A., given the submitter's address and the FDA submission process.

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 or adjudicators to establish ground truth for this device. The ground truth (OPA concentration) was established by preparing germicide solutions at known concentrations (0.3% and 0.4%).

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1, none) is described. The assessment appears to be based on whether the test strip exhibited the expected color change (yellow to magenta) at the specified OPA concentrations.

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

• No MRMC comparative effectiveness study was done. This type of study typically involves human readers assessing cases. The Opaciden OPA Solution Test Strip is an indicator device; its performance is based on a chemical color change, not human interpretation of complex images or data.

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

• The performance assessment described is inherently a standalone test of the device. The "algorithm" is the chemical reaction and color change of the test strip itself. No human interpretation is involved beyond visually observing the color change.

7. Type of Ground Truth Used

• The ground truth used was known solution concentrations. Germicide solutions were prepared with exact concentrations of ortho-phthalaldehyde (0.3% and 0.4%).

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of machine learning or AI. This is a chemical indicator device, not an AI or algorithm-based system that requires training data.

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

• As mentioned above, there is no training set described for this device.

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SteriChek® Blood Leak Reagent Strips provide a quick convenient means of testing for occult blood in dialysate.
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.

The device is made up of a 0.20 inch square yellow reagent pad that has been chemically treated to detect the presence of blood in the dialysate solution used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. To use the reagent strip, the reagent pad is immersed in the sample, removed immediately and allowed to react for 60 seconds. The reagent pad is then compared with the color blocks on the bottle label. The Negative color block is yellow with small blue-green speckles. If a reagent pad has a similar yellow color 60 seconds after reaction with dialysate, then the dialysate does not contain significant blood. The Positive color block is green. A reagent pad with color equal to or darker than the Positive color block indicates the presence of significant blood leak. The speckles on the color blocks represent the reaction image that might be left by intact red blood cells that might land on the reagent pad.

Acceptance Criteria and Device Performance Study

The information provided describes the SteriChek® Blood Leak Reagent Strips, a device designed to detect occult blood in dialysate. The acceptance criteria and the study proving the device meets these criteria are outlined below.

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 size used for the test set in terms of the number of individual blood samples. However, it mentions that the performance characteristics were analyzed with suspensions of whole blood in dialysate and solutions of human hemoglobin in dialysate.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

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 experts to establish ground truth for the test set. Instead, the ground truth for hemoglobin concentration was established using a standardized laboratory method.

4. Adjudication Method for the Test Set

Not applicable. The study primarily focused on comparing the sensitivity of the device to a predicate device and a quantitative laboratory method 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 performed. The study described is a comparison of the device's sensitivity to a predicate device and a laboratory standard.

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

Yes, the study appears to evaluate the device in a standalone manner. The "device performance" refers to the chemical reaction and color change of the reagent strip itself, which is then visually compared to color blocks. While a human is involved in the visual comparison, the core "performance" attributed to the device is its ability to react to and indicate the presence of blood at certain concentrations.

7. The Type of Ground Truth Used

The ground truth used was measured hemoglobin concentration using the Drabkin spectrophotometric method. This is described as "the standard used in most laboratories" where hemoglobin is converted to a stable pigment (cyanmethemoglobin) and its absorbance is measured at 540 nm with a spectrophotometer. The absorbance value directly measures the hemoglobin present.

8. The Sample Size for the Training Set

The document does not describe a "training set" as this device is a chemical reagent strip, not a machine learning or AI-driven system that typically involves training data.

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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SteriChek® Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek® Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde

The device is made up of a 0.20 inch square light red reagent pad that has been chemically treated to test the concentration of Glutaraldehyde in solutions for disinfecting dialyzers used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

The provided text describes the SteriChek® Glutaraldehyde Reagent Strips, a qualitative reagent strip method designed to measure Glutaraldehyde concentration in dialyzer disinfecting solutions. The regulatory submission (K040660) focuses on establishing substantial equivalence to a predicate device, the Serim™ Glutaraldehyde Test Strips.

Here's an analysis of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a table. However, it indicates the device's performance characteristics are based on analytical studies and that it effectively measures the pH or hydrogen ion concentration, which is the underlying mechanism for both the proposed device and its predicate.

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

The document states, "Assessment of The performance characteristics of SteriChek Glutaraldehyde Reagent Performance: Strips are based on analytical studies using samples of Glutaraldehyde solutions of various concentrations."

• Sample Size for Test Set: Not specified. The document only mentions "samples of Glutaraldehyde solutions of various concentrations."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Due to the nature of the device (reagent strips for chemical testing), it's highly likely to be prospective laboratory studies.

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

This information is not provided in the document. The ground truth was established by a reference method, not by human experts interpreting the device's output.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an analytical reference method for Glutaraldehyde concentration, not by human interpretation requiring adjudication.

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 clinical interpretation where human readers are involved. This device is a chemical reagent strip.

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

The device itself is a standalone chemical test; therefore, its performance assessment is inherently standalone. The study evaluates the reagent strip's ability to react to Glutaraldehyde solutions. There is no "algorithm" in the modern sense as this device is a chemical indicator system.

7. The Type of Ground Truth Used

The ground truth for the performance assessment was established using a reference chemical assay method: "The reference method for determination of Glutaraldehyde is based on the reaction of Glutaraldehyde with hydroxylamine hydrochloride followed by titration of the released acid (Aldrich Chemical Company, "Basics Assay Method for Determination of Determination of Aldehydes and Ketones".)"

8. The Sample Size for the Training Set

Not applicable. The device is a chemical reagent strip. There is no machine learning "training set" in the context of this device.

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

Not applicable, as there is no "training set" for this type of device. The chemical formulation and performance were likely developed through standard chemical and product development processes.

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