Search Results

The Chlorine Sentinel II is intended for use by hemodialysis professionals as a secondary chlorine device to provide continuous monitoring of Combined Chlorine. It is not intended to replace the primary method of monitoring chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system does not come into direct contact with feed water used to prepare dialysate.

Chlorine Sentinel II is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. It detects dissolved combined chlorine in concentrations at or above 10 PPB by primary detection technology. It self-monitors for maintenance-required conditions and loss of electrical power.

The Chlorine Sentinel II is self-testing. It uses chlorinated city water to automatically test the chlorine detecting functionality of the device once a day and records if the test passed, failed to detect chlorine, or didn't rinse out after detecting chlorine.

The device is designed to use as little water as possible. The sampling water is only used for the length of time that it takes for the chlorine test to be completed. The customer determines how frequently the test needs to be taken from every 5 minutes to every 20 minutes. The user also sets the start time and end time for each day of the week.

The Chlorine Sentinel II has two combined chlorine concentration set points. The user can set a warning set-point at a value of 0.01 PPM to 0.09 PPM. Once the chlorine concentration exceeds this value, the device will alarm at 2-HZ to warn the user of chlorine present at that set-point. The second set-point is factory set at 0.10 PPM.

A chlorine concentration equal to or above the 0.10 PPM set-point will activate the buzzers and the red chlorine alarm indicators at 5 HZ for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The alarms can be by-passed. When by-passed the pulsing lights will turn solid and the buzzer will double click over 15 minutes.

The front cover of the device has two screens. The screen of the chlorine monitor indicates the presence of combined chlorine when the value is not 0.000. The touch screen is used to enter user data and show the statuses of the device.

This FDA 510(k) clearance letter for the Chlorine Sentinel II provides limited specific details on acceptance criteria and study methodologies, particularly concerning clinical performance. The focus is on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for clinical performance that can be directly compared to reported device performance metrics like sensitivity, specificity, or accuracy. Instead, the substantial equivalence is drawn based on similar intended use, technological characteristics, and performance verified through bench testing.

Based on the "Detailed Comparison of the Subject and Predicate Devices" (Page 8-10) and "Testing" (Page 14), here's a synthesis of what can be inferred about performance:

Note: The document primarily focuses on technological equivalence and adherence to safety/testing standards rather than presenting quantitative performance metrics against specific clinical acceptance criteria for sensitivity, specificity, or accuracy in a diagnostic context. This device is a water purification system component, not a diagnostic tool.

2. Sample Size for Test Set and Data Provenance

The document describes "Performance – Bench" testing but does not specify a "test set" in the context of clinical data, nor does it provide a sample size in terms of number of cases or data provenance (country, retrospective/prospective). The studies are bench-level evaluations of the device's technical specifications and linearity.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be against established analytical standards (CLSI EP06-A, EP17-A2) for linearity and detection limits, and engineering standards for safety and electromagnetic compatibility.

4. Adjudication Method

As there is no mention of human expert review or a "test set" in a clinical sense, there is no adjudication method described.

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

No MRMC study was done, as this device is a water purification system component and not a diagnostic device involving human interpretation of medical images or data. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

The device operates standalone in its function of monitoring chlorine. The "Performance – Bench" testing described would fall under a standalone performance evaluation, but not in the sense of a medical AI algorithm. It's a measurement device whose performance is assessed against technical specifications and analytical standards.

7. Type of Ground Truth Used

The ground truth used for performance validation appears to be:

• Analytical Standards: CLSI standard EP06-A for linearity and CLSI standard EP17-A2 for limit of blank, limit of quantitation, and limit of detection.
• Functional Specifications: The device's ability to detect chlorine at specified concentrations (e.g., 0.10 PPM alarm, 0.01 PPM warning) and perform self-tests.
• Engineering Standards: IEC 61010-1 for electrical safety and IEC 60601-1-2:2020 for electromagnetic compatibility.

This is not "expert consensus, pathology, or outcomes data" as typically seen in diagnostic device clearances.

8. Sample Size for the Training Set

The document does not mention a "training set" as it would be understood for machine learning or AI algorithms. The device's operation is based on a polarographic sensor and PLC control, not a learned model from a dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of machine learning or AI for this device.

Ask a specific question about this device

E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).

Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with free chlorine and combined chlorine (monochloramines). The pad is attached to a plastic strip for handling.

The Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) are designed to provide an accurate and convenient method for measuring the concentration of free chlorine remaining in water after rinsing equipment following disinfection.

Here's an analysis of the acceptance criteria and the study conducted for the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating that the subject device consistently generates color change that meets the color blocks for reference solution concentrations, similar to the predicate device. The performance is assessed qualitatively (for detecting levels above 0.5 ppm) and semi-quantitatively (for interpolating concentrations between 0 ppm and 5 ppm).

From the "Non-clinical Performance Data" section:
"The test data confirms the subject device and the predicate device consistently generates color change which meets the color block(s) for the reference solution concentrations tested. This data demonstrates appropriate performance for the detection of residual free chlorine in rinse water that was used in disinfection of hemodialysis equipment fluid pathways."

Given this, the table would look like this:

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

The document does not explicitly state the sample size used for the test set. It mentions "reference solution concentrations tested" implicitly indicating multiple concentrations were used. The data provenance is not specified (e.g., country of origin, retrospective/prospective), but it is a non-clinical performance study.

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 to establish ground truth for the test set. The ground truth appears to be established by using "reference solution concentrations," which implies a controlled laboratory setting where the actual chlorine concentrations are known.

4. Adjudication Method for the Test Set:

No adjudication method is described. The comparison is against "color block(s) for the reference solution concentrations tested," suggesting a direct visual comparison by the test personnel.

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. The study is a non-clinical performance evaluation comparing the subject device's color change against known reference solutions and its predicate device. This device is a test strip, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

No, a standalone (algorithm only) performance study was not done. This device is a manual test strip that requires human observation and interpretation of color change to determine chlorine levels. It does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth used is based on known, controlled reference solution concentrations of free chlorine in water. These are prepared solutions with precisely measured amounts of chlorine.

8. The Sample Size for the Training Set:

This device is a chemical test strip, not a machine learning or AI-driven product. Therefore, there is no "training set" in the context of algorithm development. The performance data is generated through testing the strips against various known concentrations.

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

As there is no training set for this chemical test strip, this question is not applicable. The device's performance is inherently based on its chemical reactivity and the visual interpretation of the resulting color change against a predefined color chart.

Ask a specific question about this device

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop.

The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area.

A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller.

A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.

The provided document is a 510(k) summary for the Nelson Sentinel Series Basic Chlorine Sentinel, a device intended for continuous monitoring of total chlorine in water purification systems for hemodialysis.

However, the document does not contain the level of detail requested for acceptance criteria and the study proving the device meets these criteria in the context of an AI/ML-based medical device performance study. This document describes a hardware device for chemical measurement and its equivalence to predicate devices, not an AI/ML algorithm.

Therefore, many of the specific questions about AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance, cannot be answered from the provided text.

Here's an attempt to extract what is available regarding acceptance criteria and performance, reinterpreting some points for a hardware device context where applicable, and explicitly stating where information is missing for an AI/ML context:

Acceptance Criteria and Device Performance (Based on the provided document for a hardware device)

The document primarily focuses on establishing "substantial equivalence" of the Nelson Sentinel Series Basic Chlorine Sentinel to predicate and reference devices, rather than defining explicit acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would for an AI/ML diagnostic. The equivalence is shown through comparison of intended use, technological characteristics, and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a hardware device for chemical detection and not an AI/ML algorithm, the "acceptance criteria" are implied by performance tests to demonstrate safety and effectiveness for its intended use and similarity to established devices. The "reported device performance" refers to the results of these bench tests demonstrating the device's operational range and accuracy within its specified function.

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

• Sample Size for Test Set: Not explicitly stated in the document. The document mentions various "studies" (Linearity, Precision, LoB/LoQ/LoD, Method Comparison, Free Chlorine, 15 Weeks Calibration), but does not provide details on the number of samples or measurements used in these bench tests.
• Data Provenance: The studies were performed as "Bench Testing." The origin of the water samples or the specific laboratory where tests were conducted is not specified, but it would be laboratory-based testing relevant to water purification for hemodialysis. The document does not specify if the data was retrospective or prospective in the context of an AI/ML study, as it's not an AI/ML device.

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

• This question is not applicable as the device is a chemical sensor, not an AI/ML device requiring expert interpretation for ground truth. Ground truth for chlorine concentration would be established by analytical chemistry methods (e.g., lab-grade spectrophotometry, titration).

4. Adjudication Method for the Test Set

• Not applicable for a chemical sensor device.

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

• Not applicable. This is a hardware device for chemical detection; MRMC studies are relevant for evaluating diagnostic image interpretation by humans, often with and without AI assistance.

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

• Not applicable as this is not an AI/ML algorithm. The "performance" refers to the device's ability to accurately measure chlorine and provide alerts.

7. The Type of Ground Truth Used

• For the performance testing mentioned (Linearity, Precision, etc.), the ground truth for chlorine concentration would have been established by accurate chemical analysis methods in a laboratory setting (e.g., using reference standards and validated analytical techniques). It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of Document Relevance to AI/ML Device Analysis:

This document is a regulatory submission for a physical medical device (a chlorine monitor) demonstrating its substantial equivalence to pre-existing devices. It details the device's functional characteristics, intended use, and bench testing performed to ensure safety and effectiveness. It does not provide information related to the development, validation, or performance of an AI/ML algorithm, which would require a significantly different set of acceptance criteria and study designs focusing on model performance metrics, data sets, and human-AI interaction.

Ask a specific question about this device

The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.

Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with Ozone. The pad is attached to a plastic strip for handling.

Here's an analysis of the provided text regarding the E-Z Chek® Ozone Test Strips, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly performance-driven, relating to the ability of the test strips to accurately detect and differentiate ozone concentrations.

Study Information:

The provided document offers a high-level summary of the device's performance but lacks detailed information about the specific study design and methodology. Due to this limitation, many of the requested points cannot be fully addressed.

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

• Sample Size: Not specified in the provided text. The document states "The data confirms the product consistently generates color change...", but does not provide numbers of tests, samples, or replicates.
• Data Provenance: Not specified. It's highly probable the testing was conducted internally by Reprocessing Products Corporation, but the location and whether it was retrospective or prospective is not mentioned.

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

• Number of Experts: Not applicable/not specified. This device is a chemical test strip with a visual color change. The ground truth would be established by preparing water samples with known, precise concentrations of ozone (reference solutions), not by expert interpretation of the test strip results in a clinical setting.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As noted above, the assessment likely involves comparing the color change on the strip to a pre-defined color chart, with the "ground truth" being the known ozone concentration of the reference solution. This is a direct chemical measurement, not a subjective interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. These studies are typically for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance to measure reader improvement. The E-Z Chek® Ozone Test Strips are a direct chemical test.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance: While the principle of comparing the strip's color to a color chart is "standalone" in that a human is reading the result from the strip itself, there isn't an "algorithm" in the typical sense of AI/machine learning. The device is the algorithm (chemical reaction + color change). The performance data is the standalone performance of the physical test strip.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used would be reference solutions with known, precisely measured concentrations of ozone. The test strips' color changes are then compared against these known concentrations. This is implied by the statement "The data confirms the product consistently generates color change which meets the color block for the reference solution concentration."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. Chemical test strips are developed through chemical formulation and calibration, not typically by training a machine learning model on a "training set" of data in the way an AI-powered diagnostic device would be. The development likely involved numerous trials to achieve the desired chemical reaction and color scale, but this isn't a "training set" in the AI sense.

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

• How Ground Truth for Training Set Was Established: Not applicable in the context of an AI training set. For chemical test strip development, the "ground truth" in development would be the precisely prepared and verified ozone concentrations of water samples used to calibrate the color scale and ensure the chemical reagents react appropriately. This typically involves analytical chemistry techniques to confirm the actual ozone levels in control solutions.

Ask a specific question about this device

The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).

Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling. The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.

The provided document describes the Reprocessing Products Corporation (RPC) Total Chlorine Test Strips. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative pass/fail format with specific thresholds. Instead, it describes the intended performance and then presents data confirming that performance.

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

• Sample Size for Test Set: The document states that "Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine." However, it does not specify the number of individual tests or measurements performed with these reference solutions. It does list the specific gradations for each test strip range (e.g., 0 ppm, 0.01 ppm, 0.02 ppm for Ultra-Low Total Chlorine).
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective. Given the nature of a 510(k) submission for a test strip, it's highly likely that the performance evaluation was conducted prospectively in a laboratory setting using prepared reference solutions.

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

This type of testing for chemical reagent strips does not typically involve human experts establishing "ground truth" in the same way as medical imaging or clinical diagnoses. The "ground truth" is established by the known concentrations of the reference solutions themselves. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used when there's subjective interpretation or disagreement among human readers/experts. For these test strips, "ground truth" is determined by the precisely known concentrations of the reference solutions. The interpretation of the color change on the strip is then compared against a pre-defined color chart.

The document indicates: "The color change is interpreted by the use of color blocks on two separate (ranges) color charts." This suggests a direct comparison method rather than an adjudication process. Any discrepancies would likely point to a failure of the strip or the reading process, not an issue with establishing ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device. MRMC studies are used to evaluate the impact of a device (often AI) on human reader performance in interpreting medical images or clinical data. This device is a semi-quantitative chemical test strip; its performance is assessed against known chemical concentrations, not through human diagnostic accuracy with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was performed. The entire performance section "The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine..." describes the device's performance in isolation using reference solutions. It does not involve human readers interpreting results in a variable "human-in-the-loop" setting.

7. Type of Ground Truth Used

The type of ground truth used is known chemical concentrations (reference solutions). The performance of the test strips is validated by comparing the color change produced by the strip when exposed to these reference solutions against the expected color block for that known concentration.

8. Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning algorithms. Since this device is a chemical reagent test strip, it does not involve a machine learning algorithm and therefore does not have a "training set" in the conventional sense. The development of the chemical formulation and color chart would involve R&D and calibration, but not a dataset for algorithm training.

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

As there is no "training set" for a machine learning algorithm, this question is not applicable. The ground truth for the performance evaluation (test set) was established by using precisely prepared reference solutions with known concentrations of chlorine.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the concentration of total chlorine present in the sample.

The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the amount of total chlorine present in the sample.

The provided text describes the SteriChek™ Total Chlorine Reagent Strips, a device for testing total chlorine levels in water for dialysate preparation. Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Sample Size: The document states "water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels." However, it does not specify the exact number of samples or the range of concentrations tested beyond 0-3 ppm and 0.1 ppm low-level detection.
   • Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (USA), it's highly probable the testing was conducted in the USA. It's a retrospective analysis of the device's performance against controlled samples.

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

   • The document does not mention the use of human experts to establish ground truth for visual comparison. The "color blocks are calibrated in terms of chlorine concentration," implying a predefined standard. The "color of the pad is visually compared to a color chart" by the user.

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

   • None is explicitly stated. The device relies on a direct visual comparison by the user to a color chart.

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 study was not done. This device is a simple reagent strip with visual comparison, not an AI-powered system or one that requires human readers in the traditional sense of medical image interpretation.

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

   • Yes, a standalone performance assessment was done. The performance of the SteriChek™ strips was directly compared to the predicate device's performance using water samples with known chlorine concentrations. The "algorithm" here is the chemical reaction on the strip leading to a color change, which is then interpreted by visual comparison. The study assesses the inherent ability of the strip to accurately reflect chlorine concentration.

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

   • The ground truth was established by known, precisely prepared chemical concentrations of free chlorine and chloramines in water samples. These were "water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels."

7. The sample size for the training set:

   • The document does not specify a separate training set. This is a chemical reagent strip, not a machine learning model that typically involves training data. The "calibration" of the color chart would have been done during the device's development, but details on that process or sample sizes are not provided within this summary.

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

   • As there's no explicitly mentioned training set in the context of machine learning, this question is not fully applicable. However, the ground truth for calibrating the color chart (which informs the "training" aspect of the device's functionality) would have been established through controlled laboratory experiments using precisely measured concentrations of chlorine to correlate color intensity with ppm values. This process is implied by the statement "The color blocks are calibrated in terms of chlorine concentration."

Ask a specific question about this device

SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.

The device consists of utilizing a fixed sample size of powdered reagent with a predetermined water sample volume in a test tube to effect a color reaction in the water sample. The color of the sample is then visually compared to a colormetric comparator to determine the total chlorine level in the sample. The device utilizes a recognized standard method of analysis for determining levels of total chlorine in water according to the Association for the Advancement of Medical Instrumentation (1993 Association for the Advancement of Medical Instrumentation-ANSI/AAMI;RD5-1992).

The provided text describes a medical device, the SteriChek™ Total Chlorine Test Kit, and its 510(k) submission for market clearance. However, the document primarily focuses on the device's description, intended use, and a comparison of its performance to a predicate device. It does not explicitly state specific acceptance criteria (performance targets/thresholds) or a detailed study plan that demonstrates the device meets those criteria.

Instead, it states that the "Performance of both devices was equivalent," referring to the SteriChek™ kit and its predicate device (Serim™ HiSense Test Strips). This implies that the acceptance criteria for the SteriChek™ kit were to show performance equivalent to the legally marketed predicate device.

Therefore, many of the requested details about the study are not explicitly available or are not applicable in the typical sense for a substantial equivalence submission relying on a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "water samples in which either sodium hypochlorite or monochloramines were added to give a range of free chlorine or combined chlorine levels." The number of these samples is not provided.
• Data Provenance: Not explicitly stated, but the submission is from Environmental Test Systems, Inc. in Elkhart, IN, USA. It's likely the testing was conducted in the USA, but this is not explicitly confirmed. The study appears to be prospective in the sense that the SteriChek™ kit was analyzed with new samples.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not mentioned. The device involves visual comparison to a colorimetric comparator. It's possible that a single operator/technician compared the colors, but details are not provided.

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:

• MRMC Study: No. This device is a chemical test kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable.

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

• Standalone Performance: The device itself is a "standalone" chemical test kit. Its performance is based on the chemical reaction and visual comparison, not an algorithm. The description implies human-in-the-loop for visual comparison, as the color of the sample is "visually compared to a colormetric comparator."

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

• Type of Ground Truth: The ground truth was established by adding known concentrations of "sodium hypochlorite or monochloramines" to water samples. This creates a synthetic but precisely known (reference) concentration of free or combined chlorine, against which the device's readings are compared.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. The device is a chemical test kit, not a machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study performed was a comparison study where the SteriChek™ Total Chlorine Test Kit was evaluated against a predicate device, Serim™ HiSense Test Strips. Both devices were tested with water samples prepared with known concentrations of either sodium hypochlorite (for free chlorine) or monochloramines (for combined chlorine). The objective was to demonstrate that the SteriChek™ kit's performance was "equivalent" to the predicate device. Details on the specific number of samples, how the comparison was quantified (e.g., specific accuracy metrics), or who performed the readings are not provided in this summary. The ground truth was based on the precisely prepared known concentrations of chlorine in the water samples.

Ask a specific question about this device