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The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The CLMIII consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber.

The provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the document is a 510(k) summary for the CRIT-LINE Monitor III (CLMIII), which seeks substantial equivalence to a predicate device, the CRIT-LINE II (CLMII). The basis for this equivalence is primarily technological similarity and comparison testing under simulated clinical conditions rather than a formal clinical study with defined acceptance criteria for diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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. The document mentions "comparison testing to the predicate was performed on blood bank blood." It does not specify the number of blood samples or the volume of blood used.
• Data Provenance: "Blood bank blood" used for testing. The location was "at In-Line Diagnostics, Inc." This suggests in vitro or ex vivo testing under simulated clinical conditions, not data from human patients. The testing was retrospective in the sense that existing blood bank samples were used, but not clinical data from patients.

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

• Not applicable / Not stated. The testing described is a comparison to a predicate device using blood bank blood under simulated conditions. There is no mention of "ground truth" establishment by human experts for diagnostic purposes (e.g., categorizing disease states). Instead, the "ground truth" implicitly would be the measurements obtained from the predicate device and/or standard laboratory methods for hematocrit and oxygen saturation, if such methods were used for comparison (though not specified).

4. Adjudication Method for the Test Set

• Not applicable / Not stated. No adjudication method is described because the testing did not involve human interpretation or subjective assessments that would require adjudication.

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

• No. An MRMC study was not done. The device (CRIT-LINE Monitor III) is an automated monitoring device; it does not involve human readers interpreting images or data where AI assistance would be a factor. The comparison was to a predicate device's measurements, not to human performance.

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

• Yes, effectively. The CRIT-LINE Monitor III is an automated device that provides real-time measurements. The testing described was a comparison of this automated device's output to that of the predicate automated device (CLMII) using blood bank blood. There is no human "in the loop" for the measurement itself, only for interpreting the output data and making clinical decisions (by a dialysis technician).

7. The Type of Ground Truth Used

• The "ground truth" for the comparison testing was likely measurements from the predicate device (CRIT-LINE II) and/or established laboratory methods for hematocrit and oxygen saturation. The document explicitly states "Comparison testing to the predicate was performed on blood bank blood." It does not specify if external laboratory gold standards were simultaneously used to verify either device's accuracy beyond the comparison to the predicate.

8. The Sample Size for the Training Set

• Not applicable / Not stated. The CRIT-LINE Monitor III seems to be based on physical principles of light absorption rather than a machine learning model that requires a "training set." Therefore, a training set in the AI/ML sense is not relevant here. The device hardware and software are "state-of-the-art microprocessor[s]" designed to implement existing algorithms for light absorption measurement and calculation.

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

• Not applicable. As noted above, there is no mention or indication of a "training set" for a machine learning model.

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