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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 Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.

The Vital Sync™ System displayed parameters are listed on the following pages.

WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.

The Vital Sync™ System is being extended to offer additional device compatibility and parameter display.

The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.

Below is an analysis of the provided text regarding the Vital Sync™ System, Model 5000:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described is focused on the device's technical functionality, specifically "driver validation and regression testing." The provenance of any data used for these technical tests is not mentioned (e.g., country of origin, retrospective/prospective).

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

Not applicable. The ground truth for this device's performance was established through technical validation and regression testing against the predicate device's expected behavior, not through expert review of patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no adjudication method described as the testing was technical validation and regression testing, not a clinical study requiring expert consensus.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physiological parameter display and recording system, not an AI-assisted diagnostic tool.

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

Yes, in a sense, a standalone performance assessment was conducted for the device's core functionality. The "driver validation and regression testing" evaluated the device's ability to accurately receive and display data from compatible bedside devices. This testing would have assessed the algorithm's performance in managing and presenting data, independent of human interpretation of the displayed parameters.

7. The Type of Ground Truth Used

The ground truth used was the expected and validated behavior of the predicate Vital Sync™ System. The new device's performance in terms of data integrity and accurate display was compared against this established baseline. This is a form of technical validation against a known, established standard (the predicate device's functionality).

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device clearance process for an update to an existing system, not the development of a machine learning or AI algorithm that would require a "training set."

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

Not applicable, as there was no training set mentioned or implied for this device.

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