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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 Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.

The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

The Q Core Sapphire infusion pump the result of modifications to the FDA cleared AP 34 Infusion pump (K082182). The modifications were changes to the user interface and additional functions that include new delivery modes and the Drug Library feature. There are no changes to the basic infusion pump technology. Like its predicates, the Sapphire is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alams for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and in pre-hospital medical ground transportation.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single-patient use and single use only.

This document, K123049, is a 510(k) summary for the Q Core Sapphire Infusion Pump System. It details the device description, indications for use, technological characteristics, and pre-clinical testing performed to establish substantial equivalence to predicate devices. The document does not contain acceptance criteria for specific performance metrics or detailed study results that "prove the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with defined sensitivity/specificity targets.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a series of pre-clinical tests and comparisons of technical characteristics.

Here’s a breakdown of the information based on your request, highlighting what is (and isn't) present in this 510(k) summary:

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

The document does not provide a table of acceptance criteria with reported performance values in terms of specific sensitivity, specificity, accuracy, or similar quantitative metrics for a diagnostic claim. The "performance" is demonstrated through compliance with recognized standards and comparison to predicate devices, rather than a direct measurement against a predefined criterion table.

The preclinical testing section lists the types of tests performed and the standards they adhere to. These standards implicitly contain acceptance criteria that the device must meet, but the specific numerical results of these tests (e.g., how accurate the pump was in terms of percentage deviation) are not included in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes the types of preclinical tests performed (e.g., electrical safety, pump accuracy), but does not detail sample sizes for these tests or the provenance of any data used. This is typical for submissions focused on mechanical/electronic device performance and compliance with a standard, rather than clinical efficacy studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. This 510(k) summary is for an infusion pump, which is a hardware device for drug delivery, not a diagnostic device that requires expert adjudication for ground truth (e.g., medical imaging analysis). The performance evaluation relies on engineering tests against established standards.

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

This information is not applicable and therefore not provided. As explained above, this is not a diagnostic device involving 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

This information is not applicable and therefore not provided. An infusion pump does not involve human readers interpreting data, nor does it incorporate AI in a way that would lead to an MRMC study.

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

This information is not applicable and therefore not provided. The device is a physical pump, not an algorithm, so a standalone algorithm performance study is irrelevant.

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

The "ground truth" for the tests mentioned (e.g., pump accuracy, electrical safety) would be established by the specifications and criteria outlined in the respective IEC and ISO standards. For example, for pump accuracy, the ground truth would be the expected flow rate vs. the measured flow rate within acceptable deviations defined by IEC 60601-2-24. This is a technical specification compliance model, not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

This information is not applicable and therefore not provided. The Q Core Sapphire Infusion Pump is not an AI/ML-driven device that utilizes a training set in the conventional sense.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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