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The Crit-Line IV System is used to non-invasively to measure hematocrit, oxygen saturation and percent change in blood volume. The Crit-Line Clip (CLiC) measures 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 dial. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The intended use of the Crit-Line IV System is as a continuous real-time blood monitoring system for displaying information measured by the CLiC sensor, including hematocrit, oxygen saturation, and percent change in blood volume. The Crit-Line IV System is comprised of the Crit-Line IV monitor (the subject of this submission), the Crit-Line Clip (CLiC) sensor, and the Crit-Line Clip Blood Chamber. The touchscreen interface and display of the Crit-Line IV monitor is used with the hardware and software of the CLiC sensor, which is a separate component of the Crit-Line Clip (CLiC) Monitor, K121599. Information displayed on the Crit-Line IV monitor may be viewed real-time during a dialysis treatment. There are additional display features incorporated into the Crit-Line IV System, which are similar to that of the Crit-Line III system (K972470) and the 2008T Hemodialysis Machine with (optional) CLiC (K131908). For this reason, the Crit-Line Clip Monitor (CLiC: K121599), is the predominant predicate and the 2008T Hemodialysis Machine with (optional) CLiC (K131908) and the Crit-Line III (K972470) are reference predicate devices.

The provided text describes the Crit-Line IV System, a device used in hemodialysis to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices. While it generally discusses performance testing, it does not provide explicit acceptance criteria with numerical thresholds or specific reported device performance values in a table format.

However, based on the descriptions in the "Performance Data" and "Conclusion" sections, we can infer the approach taken to demonstrate performance.

Here's an analysis of the provided information, addressing your questions to the best of what the text offers:

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

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values for clinical or analytical accuracy. The "Performance Data" section states that "Performance testing requirements were determined through the application of a risk management process and applicable performance standards," and "Performance testing included software verification, electrical safety testing, electromagnetic compatibility (EMC) testing, intentional EM emissions immunity simulation testing, coexistence testing with RFID equipment, ship testing, and usability testing."

The "Conclusion" states, "The information provided in this submission demonstrates the Crit-Line IV System functions as intended and is substantially equivalent to the predicate devices. The test results demonstrate that the proposed device does not raise any new concerns with regard to safety or effectiveness."

This suggests that the "acceptance criteria" were qualitative (e.g., successful software verification, passing electrical safety tests, meeting EMC standards, demonstrating usability), rather than quantitative performance metrics for hematocrit, oxygen saturation, or blood volume changes relative to a gold standard.

Inferred Acceptable Performance Categories:

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

The document does not specify a sample size for clinical test sets or analytical accuracy studies for the measurement parameters (hematocrit, oxygen saturation, percent change in blood volume). The performance data cited refers to various engineering tests (software verification, electrical safety, EMC, usability) rather than patient or sample-based clinical performance data. Therefore, details regarding data provenance (country of origin, retrospective/prospective) are also not provided.

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)

Given the nature of the described performance data (engineering and usability testing), the concept of "experts establishing ground truth" for specific clinical measurements (like a pathologist for a biopsy) is not directly applicable in the information provided. For usability testing, healthcare professionals (e.g., nurses, technicians operating dialysis equipment) would typically be involved, but their number and specific qualifications are not detailed. For other engineering tests, the "experts" would be engineers and technical personnel conducting the tests, ensuring compliance with relevant standards.

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

No adjudication method is described, as the document does not present results from studies requiring expert interpretation or consensus on clinical findings. The performance tests mentioned (software, electrical safety, EMC, usability) typically involve objective measurements against predefined criteria/standards, rather than subjective interpretation requiring adjudication among experts.

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. The Crit-Line IV System is a monitoring device that provides direct measurements (hematocrit, oxygen saturation, % change in blood volume) to a clinician. It is not an AI-assisted diagnostic imaging device that involves "human readers" interpreting images "with or without AI assistance." Therefore, an MRMC comparative effectiveness study or related effect size is not applicable to this device as described.

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

The device's core functionality is standalone measurement of physiological parameters (hematocrit, oxygen saturation, % change in blood volume) and display of this information. The algorithms for calculating △BV% and estimating hemoglobin (Hb) are standalone in the sense that they process the data from the CLiC sensor without human intervention in their calculation. However, the system is designed to provide this information for a "clinician/nurse, under physician direction," to intervene in the patient's treatment. So, while the measurement and calculation algorithms operate without human intervention, the overall clinical use of the device is human-in-the-loop, as the data guides clinical decisions.

The document states, "The algorithms used in the proposed monitor software for calculating △BV% and estimating hemoglobin (Hb) are the same algorithms used in the software driver provided with the predicate Crit-Line Clip (CLiC), K121599." This implies that the standalone performance of these algorithms was previously established or is considered equivalent to the predicate.

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

For the core measurements of hematocrit, oxygen saturation, and percent change in blood volume, the ground truth would typically be established by validated laboratory methods (e.g., standard hematology analyzers for hematocrit, blood gas analyzers for oxygen saturation). However, the document does not explicitly state how the ground truth was established for these measurements or if analytical accuracy studies against such ground truth methods were part of this particular submission's performance data. Given the focus on substantial equivalence and engineering tests, it's possible that analytical accuracy was either assumed from the predicate devices or demonstrated in prior submissions for the CLiC sensor itself (K121599), which provides the raw data.

8. The sample size for the training set

Not applicable. This device is a medical monitoring instrument that uses established algorithms for calculation. It is not a machine learning or artificial intelligence device that requires a "training set" in the context of developing a statistical model or neural network. The algorithms for △BV% and estimated Hb are stated to be the same as those in predicate devices, implying they are fixed algorithms rather than adaptable, learned models.

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

Not applicable, as there is no "training set" for this device in the machine learning sense. The algorithms are based on scientific principles and previously validated methodologies, likely derived from extensive previous research and clinical data during their initial development, but this document does not detail their original establishment.

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The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. A Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, and was not available with the predicate device, the DBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in the prevention of excessive removal of fluid.

The Acceptance Criteria and the study proving the device meets these criteria for the NIKKISO DBB-06 HEMODIALYSIS DELIVERY SYSTEM, specifically focusing on its new optional accessories, the Blood Volume Monitor (BVM) and the Non-Invasive Blood Pressure (NIBP) measurement module, are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Blood Volume Monitor (BVM):

  • Test Set Sample Size: Not explicitly stated as a number of subjects. The document mentions "Clinical Test was performed." for the DBB-06 BVM. For the predicate CRIT-LINE Monitor III (K972470), "Comparison testing was performed on blood bank blood under simulated conditions" without specifying a sample size.
  • Data Provenance: Not specified for the DBB-06 BVM clinical test (e.g., country, specific demographics). For the predicate, "blood bank blood" suggests in-vitro testing. Whether the BVM clinical test was prospective or retrospective is not explicitly stated.

• Non-Invasive Blood Pressure (NIBP) measurement module (M2500):

  • Test Set Sample Size: Not specified. The comparison relies on compliance with international standards (IEC, EN, ANSI/AAMI) and documented specifications that match the predicate devices. Performance tests of these blood pressure monitors were conducted, but the sample size for these tests is not provided in the summary.
  • Data Provenance: Not specified. The manufacturer for both the M2100 and M2500 is "Omron Colin Co., Ltd., 1-12-14 Koishikawa, Bunkyo-ku, Tokyo Japan," suggesting Japanese origin for the device's development and potentially testing data. The nature of these "performance tests" (e.g., clinical, bench, simulated) and their provenance is not detailed.

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

• Blood Volume Monitor (BVM): Not applicable. Ground truth for BVM accuracy is stated as "compare well with other methods such as centrifuge." This implies a gold standard measurement method rather than expert consensus on interpretation.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Not applicable. The ground truth for blood pressure measurement accuracy is typically established against validated reference devices (e.g., intra-arterial measurements) or through compliance with recognized standards (e.g., ANSI/AAMI SP-10). Expert interpretation of NIBP readings against a gold standard is generally not how NIBP accuracy is assessed in regulatory submissions.

4. Adjudication Method for the Test Set

Not applicable for either the BVM or NIBP module, as the assessments are based on objective measurements and compliance with technical specifications and standards rather than subjective expert review requiring adjudication.

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

Not applicable. The devices are objective measurement tools, not systems that rely on human interpretation of complex data (like diagnostic imaging). Therefore, an MRMC study to measure improvement in human reader performance with AI assistance is not relevant to this type of device.

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

• Blood Volume Monitor (BVM): Yes. The BVM's performance, including its accuracy of approximately +/-2%, operates independently to calculate blood volume based on light absorption. The "Clinical Test was performed" for the BVM would assess this standalone performance.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Yes. The M2500 NIBP module's performance, including its measuring range and accuracy (0 to 300mmHg, within +/-3mmHg), is an inherent function of the device itself. Performance tests (referenced but not detailed) would evaluate its standalone accuracy against an appropriate reference.

7. Type of Ground Truth Used

• Blood Volume Monitor (BVM): "Comparison well with other methods such as centrifuge." This refers to established laboratory methods for measuring hematocrit, which is then used to calculate blood volume.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Compliance with international standards (IEC60601-2-30, EN1060-1, EN1060-3, ANSI/AAMI SP-10) which define accuracy requirements, often referencing invasive blood pressure measurements or other validated non-invasive methods as the "ground truth."

8. Sample Size for the Training Set

No training set information is provided as the devices described (BVM and NIBP module) are based on established physical principles and algorithms, not machine learning models that require training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for these devices.

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For non-invasive monitoring, in real time, of the estimated relative blood volume percent for patients undergoing hemodialysis so that technicians may make system adjustments 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 device can also provide estimated values of: (1) relative blood volume trend; (2) hematocrit; (3) hemoglobin and (4) blood water content or mass fraction of blood water in the total blood mass.

The device is ONLY to be used in conjunction with the Fresenius Dialysis System 2008H.

There are a variety of method for measuring relative blood volume (RBV), and all make use of the fact that certain constituents of blood (cells, haemoglobin, plasma protein, total protein) remain confined to the vascular compartment, whereas the plasma water can pass both the capillary membrane (into the interstitial compartment) and the dialyser membrane (into the dialysis fluid compartment). Therefore the blood volume change can be determined from the concentration change of these blood constituents.

The Fresenius Blood Volume Monitor is only to be installed in an available bay of the Fresenius Dialysis System 2008H machine. It uses ultrasound pulses from a transmitter through a polycarbonate cuvette installed into the arterial blood line and received on the opposite side. The primary signal measure is the transient time of the sound pulse through the blood sample, from which the sound velocity is calculated. Silicone rubber is used as sound coupling for the cuvette, with the blood passing through from bottom to top to avoid accumulation of air bubbles. Blood temperature is also measure, and a temperature controlled block prevents interference from ambient temperature changes.

The sound speed depends on the blood density, which in turn depends on the mass fraction of protein and the mass fraction of water or blood water content (BWC). Since the mass of blood protein is virtually unchanged during ultra filtration, the mass of blood water changes, and thereby the density changes. Changes in BWC can be detected by changes of sound velocity, and can be converted to relative blood volume changes. Since sound velocity not only depends on density, but also on temperature, a high precision temperature measurement is also required.

Here's an analysis of the acceptance criteria and supporting studies for the Fresenius Blood Monitor, based on the provided text:

Acceptance Criteria and Reported Device Performance

Although explicit "acceptance criteria" in a quantitative table format are not directly stated, the document emphasizes the device's accuracy in comparison to existing methods. The primary performance metric mentioned is agreement with the centrifuge method and correlation with hemoglobin concentration.

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

• Study 1:
  • Sample Size: 45 patients
  • Number of Examinations: Each patient examined three times, with six values each time.
  • Data Provenance: Not explicitly stated, but the device was "developed in Europe and currently marketed outside the United States," suggesting the studies may have originated from Europe. The document refers to "6 centers," which could imply a multicenter study. It's unclear if this was retrospective or prospective, but the phrasing "examined three times" suggests a prospective collection for this specific study.
• Study 2:
  • Sample Size: 9 patients
  • Number of Comparisons: 104 comparisons with the centrifuge method.
  • Data Provenance: Not explicitly stated, but likely from similar European sources as Study 1. The phrasing "underwent 104 comparison" suggests a prospective design for this specific comparative study.

2. 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 a "ground truth" for the test set in the traditional sense of clinical diagnosis or interpretation. Instead, the ground truth was established by established measurement methods:

• Standard Method (for correlation with hemoglobin concentration): This refers to a method used to determine hemoglobin concentration, which then allows for the calculation of relative blood volume. The qualifications of who performed this "standard method" are not specified.
• Centrifuge Method: This is a laboratory technique for separating blood components to determine hematocrit, which can be an input for blood volume calculations. The qualifications of the individuals performing the centrifuging are not specified, but it's a standard lab procedure.

3. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement methods (e.g., centrifuge, standard hemoglobin measurement), not by expert consensus requiring adjudication.

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 comparative effectiveness study involving human readers and AI assistance was not conducted or reported. The device is a monitor providing real-time data, not an AI diagnostic tool requiring human interpretation improvement. The document describes studies comparing the device's measurements to other physical measurement methods.

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

Yes, the studies described are essentially "standalone" performance evaluations of the device. The device itself (the Fresenius Blood Monitor) directly measures and outputs values for relative blood volume. The reported studies evaluate the accuracy of these device-generated measurements against established "ground truth" methods (like centrifuge or hemoglobin concentration measurement) without human intervention in the interpretation of the device's primary output. The human aspect comes in subsequent clinical decision-making based on the device's output.

6. The Type of Ground Truth Used

The ground truth used was based on:

• "Standard method" for obtaining blood volume/hematocrit values (presumably laboratory-based methods) in the study correlating with hemoglobin.
• The "centrifuge method" for blood volume comparison.

These are objective, quantitative measurement methods, not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.

7. The Sample Size for the Training Set

The document does not mention a "training set" or any machine learning/AI training process. The Fresenius Blood Monitor operates based on physical principles (ultrasound sound velocity related to blood density) and algorithms derived from those principles, rather than being a machine learning model that requires a training dataset in the typical sense.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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The CRIT-LINE MONITOR III, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.

The CLM III 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 CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.

Here's an analysis of the provided text regarding the CRIT-LINE MONITOR III, structured to answer your questions:

Acceptance Criteria and Device Performance Study for CRIT-LINE MONITOR III

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 29 data points
• Data Provenance: Retrospective (though collected specifically for this validation, it's not a prospective interventional trial based on the description).
  • 16 data points from Victoria Hospital in London Ontario, Canada (April 8th and April 9th, 1999)
  • 13 data points from Central Valley Dialysis in Salt Lake City, Utah (June 22nd and June 24th, 1999)

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. The "ground truth" (or reference method) was established by calculating Access Blood Flow (ABF) values externally using CRIT-LINE MONITOR III hematocrit measurements fed into a formula via a calculator or spreadsheet program (which was the previously approved method, K982412).

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison was statistical between two calculated values (one internally by the device, one externally using device-generated hematocrit data and a formula).

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, an MRMC comparative effectiveness study was not done. This device is a monitor measuring physiological parameters; it's not an AI system for image interpretation or diagnosis that would typically involve human readers.

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

Yes, in a way. The study's purpose was to validate the internal calculation of ABF by the CRIT-LINE MONITOR III. This internal calculation is essentially the "algorithm only" performance, compared against the established external calculation method which uses data generated by the same device (CLM III hematocrit measurements) but processes it outside the device. The study is evaluating the device's self-contained ABF calculation capability.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was the previously approved method of ABF measurement, which involved:

• Measuring hematocrit values using the CLM III.
• Calculating ABF values externally via a calculator or spreadsheet program using these measured hematocrit values.
• This method itself had a 510(k) clearance (K982412).

Essentially, the ground truth was a reference calculation method using device-generated data.

8. The Sample Size for the Training Set

The document does not mention a separate training set. The CRIT-LINE MONITOR III is a physical device with a software modification for internal calculation. The description implies the software was developed based on existing understanding of the ABF formula and then validated with the 29 data points as the "test set" against the established external calculation method. It's unlikely that machine learning or a training set in the modern sense was used for this type of device in 1999.

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

As no explicit training set is mentioned, this question is not applicable. The device's internal ABF calculation functionality was evaluated against a pre-existing, legally marketed method of calculating ABF.

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The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.

The CLM III 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 CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

CRIT-LINE MONITOR III (CLM III) with Access Blood Flow (ABF) Feature

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 44 patients
  • 30 patients from the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah.
  • 14 patients from Victoria Hospital South in London, Ontario, Canada.
• Data Provenance: Prospective (described as "during normal dialysis sessions" and "during the study, a formal protocol was followed").
• Country of Origin: USA (Utah) and Canada (Ontario).

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

The ground truth was not established by human experts in this study. Instead, a predicate device, the Transonic HD01 Monitor, was used as the reference standard for Access Blood Flow (ABF) measurements.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was based on a predicate device's measurements, not expert adjudication.

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, this was not an MRMC comparative effectiveness study. The study focused on demonstrating substantial equivalence of a new feature (ABF calculation) of an existing device to a legally marketed predicate device. There is no mention of human readers or AI assistance effect sizes.

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

Yes, this was a standalone performance study. The CLM III, with its built-in capacity to measure hematocrit, was used to calculate ABF values independently. These calculated values were then compared to the ABF values obtained from the predicate Transonic HD01 Monitor. The CLM III itself did not involve human intervention in the ABF calculation process, but rather provided the raw data (hematocrit) from which ABF was calculated using external means (calculator or spreadsheet).

7. The Type of Ground Truth Used

The ground truth used was measurement from a legally marketed predicate device, specifically the Transonic HD01 Monitor.

8. The Sample Size for the Training Set

The document does not mention a separate training set. The study describes the comparison of the CLM III's ABF values to the Transonic HD01 Monitor's values. The ABF calculation method for the CLM III (from real-time hematocrit measurements) already existed, and the purpose of the submission was to claim ABF as an additional feature without hardware or software changes to the current device. Therefore, it appears the "training" was implicitly done during the initial development of the CLM III's hematocrit measurement capabilities, not specifically for the ABF feature using the data from this submission.

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

As no specific training set for the ABF feature is described, the ground truth establishment for a training set is not detailed. The CLM III's core functionality (hematocrit measurement) would have been established through prior validation. The ABF calculation itself appears to be a mathematical derivation from these pre-established hematocrit measurements, rather than requiring a dedicated training set with new ground truth data for the ABF parameter itself.

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