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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 2008T is indicated for acute and chronic dialysis therapy.

The Fresenius 2008T represents the next genesis of the Fresenius 2008K model hemodialysis machine. Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure, when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or continuous. The 2008T has the same indications for use and same intended use as the predicate device the 2008K (K994267). The Fresenius modified 2008T hemodialysis machine incorporates changes with regards to the user interface only and all water requirements, module options. functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device, the 2008K (K994267).

This 510(k) submission for the Fresenius 2008T Hemodialysis Machine primarily focuses on demonstrating substantial equivalence to a predicate device (Fresenius 2008K) due to user interface modifications only. As such, it does not involve a clinical study to establish acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are related to safety and effectiveness through the lens of equivalence to the predicate device, especially regarding the modified user interface.

Therefore, many of the typical elements requested for a device that relies on clinical performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not present in this document because they are not relevant to this specific type of submission.

Here's a breakdown of the information that is applicable or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable as this submission is for a device modification primarily concerning the user interface of an already cleared device, not a novel device requiring a clinical performance study with a test set of patient data/samples. The assessment relies on engineering principles, risk analysis, and comparison to existing validated performance.

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

Not applicable. There is no "ground truth" established in the context of diagnostic accuracy for this submission, as it's not a diagnostic device and the changes are limited to the user interface.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This device is a hemodialysis machine, not an AI-assisted diagnostic tool, and no MRMC study was performed or required for this 510(k) submission.

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

Not applicable. This refers to AI/algorithm performance, which is not relevant to this device.

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

Not applicable in the traditional sense of a clinical diagnostic study. The "ground truth" in this context is the established safety and effectiveness of the predicate device (2008K), against which the modified 2008T is compared. The assessment hinges on demonstrating that the user interface changes do not negatively impact the device's function or safety, which is inherently tied to the predicate's proven track record. This is assessed through:

• Engineering analysis
• Risk assessment
• Verification activities (implied by "mitigations have been verified")

8. The Sample Size for the Training Set

Not applicable. This term is used for AI/machine learning models. This submission does not involve such models.

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

Not applicable.

Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The study proving the device meets the acceptance criteria is not a clinical trial involving patient data or diagnostic performance metrics. Instead, it is a comprehensive engineering assessment and risk analysis comparing the modified Fresenius 2008T to its predicate device, the Fresenius 2008K.

The key points of this "study" or justification are:

• Nature of Modification: The only changes in the 2008T from the 2008K are in the user interface.
• Unchanged Features: All critical operational and functional aspects remain identical to the predicate: water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options.
• Risk Analysis: A "Risk Analysis has been completed and potential hazards associated with the modifications have been identified, mitigated and where applicable mitigations have been verified. All potential risks were deemed acceptable after mitigation." This is the primary method for demonstrating safety and effectiveness for a change of this nature.
• Indications for Use: The 2008T retains the exact same Indications for Use as the 2008K, "indicated for acute and chronic dialysis therapy."
• Conclusion of Equivalence: Fresenius Medical Care North America "believes that the information provided in this submission clearly describes the Fresenius 2008T and demonstrates that it is substantially equivalent to the Fresenius 2008K Dialysate Delivery system."

In essence, the "study" is the entire 510(k) submission itself, which articulates the limited nature of the changes and provides documentation (e.g., risk analysis results, engineering specifications – though not fully detailed in this summary) to support the claim that these user interface modifications do not introduce new safety or effectiveness concerns, thus maintaining equivalence to the predicate device.

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