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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 Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq module such as the 2008T Hemodialysis Machine and is 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.

The Fresenius 2008T Hemodialysis Machine with bibag System is the cleared 2008T Hemodialysis Machine that has been modified to enable use of a specialized, single use, sealed bag (the "bibaq") containing USP grade dry sodium bicarbonate powder to produce a saturated solution of sodium bicarbonate. The addition of the bibag system to the hemodialysis machine allows operators the option of producing a saturated sodium bicarbonate solution on-line through automated mixing of AAMI grade water and dry sodium bicarbonate powder within the bibag source disposable rather than with liquid bicarbonate concentrates. The bibag system is comprised of: (1) the bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium carbonate concentrate. A specialized bibag connector (is attached? to the hemodialysis machine.] The bibag disposable hangs on two nozzles located in the bibag connector.

The provided document describes the Fresenius 2008T Hemodialysis Machine with bibag™ system. The primary goal of the submission is to demonstrate that the modified hemodialysis machine, incorporating the bibag system, is substantially equivalent to predicate devices and functions as intended.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

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 sample sizes for any of the individual tests. It states that "Verification and validation testing were performed," but details on the number of units or test cycles are not provided. The data provenance is implied to be from internal lab testing conducted by Fresenius Medical Care North America. There is no information regarding country of origin for data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modification, the testing would typically be prospective, controlled laboratory testing.

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

This type of information is not applicable to this submission. The tests performed are objective engineering and performance validations (e.g., electrical safety, EMC, software validation, material biocompatibility, dissolution). These tests rely on predefined engineering standards and specifications, not on expert consensus or interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective and pass/fail based on meeting predefined thresholds and standards. There is no mention of subjective assessments requiring adjudication.

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

A MRMC comparative effectiveness study was not performed and is not applicable to this type of device modification. This is a technical modification to a hemodialysis machine, not a diagnostic or AI-assisted interpretation tool that would benefit from such a study.

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

This is not applicable as the device is a medical machine with integrated functionality, not a standalone algorithm. The "system performance testing" would be considered the standalone performance, but it refers to the entire machine and bibag system in operation.

7. Type of Ground Truth Used

The "ground truth" for the various tests was based on:

• Pre-determined acceptance criteria derived from
  • International and national medical device standards: IEC 60601-1-2 (EMC), UL 60601-1 (Electrical Safety), CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety).
  • Pharmacopoeial standards: USP requirements for dissolution testing of materials.
  • Biocompatibility standards: USP 32-NF26 biological tests .
  • AAMI standards: AAMI RD61:2006 for Bioburden & Endotoxin testing.
  • Internal engineering specifications: For software validation, regression testing, and overall system functionality.

8. Sample Size for the Training Set

This is not applicable. This device is a modified hemodialysis machine, not an AI/ML algorithm that requires a training set. The "training" for the device refers to its design and manufacturing processes, which are validated through the testing described.

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

This is not applicable for the same reason as point 8.

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