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The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Crit-Line Clip Monitor (CLiC) (Optional):

The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device 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 clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, 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 complications of dialysis which include nausea, cramping and vomiting.

The 2008T Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms. The 2008T Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer through platinum cross-linked silicone tubing. Balancing chambers control the dialysate during treatment. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.

The provided text is a 510(k) summary for the Fresenius Medical Care 2008T BlueStar™ Hemodialysis Machine. This document outlines the device description, indications for use, comparison to a predicate device, and performance data to demonstrate substantial equivalence to a legally marketed device.

However, the information provided does not describe acceptance criteria and a study that proves a device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The document is for a hemodialysis machine, which is an electro-mechanical device, not an AI/ML device for diagnostic or predictive purposes. The "performance data" sections are related to physical and biological safety, functional verification, and material compatibility of the hemodialysis machine itself, not validation of an AI/ML algorithm's performance on a dataset.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set size, and training ground truth establishment) as this document does not pertain to an AI/ML enabled medical device study.

To answer your request, I would need a document describing the validation of an AI/ML medical device.

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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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