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The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer. The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.

The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module. The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.

This is a 510(k) premarket notification for a medical device, specifically a hemodialysis blood tubing set. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets specific performance acceptance criteria through clinical or AI-based evaluation.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria (such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of submission.

The "Performance Data" section (G.) in the document describes validation and verification testing performed to support substantial equivalence to the predicate device, not to establish novel performance metrics or human-AI improvement.

Here's a breakdown of what can be extracted from the provided text based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise numerical acceptance criteria alongside corresponding quantitative device performance results (e.g., a specific pressure tolerance in psi for structural integrity testing). Instead, it lists general categories of testing performed to demonstrate equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided summary. The document mentions "testing was selected through the application of a risk management process," implying a chosen sample size for various tests, but the actual numbers are not reported.
• Data Provenance: Not specified. As a device manufacturer, Fresenius Medical Care would conduct these tests in their own facilities or through contracted labs. The data would be internally generated for regulatory submission. It is not clinical data from patients or countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document describes engineering and laboratory testing for device safety and performance, not a diagnostic or AI-driven system requiring expert-established ground truth for a test set. The "ground truth" for these tests would be established by validated test methods and measurement equipment.

4. Adjudication method for the test set

• Not Applicable. As above, this pertains to laboratory and engineering testing, not interpretation of clinical data by multiple 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

• Not Applicable. This device is a physical hemodialysis blood tubing set. It is not an AI-based diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the performance testing mentioned (e.g., structural integrity, pressure testing, sterility), the "ground truth" is derived from established engineering principles, scientific measurements, and validated laboratory test methods. For example, a pressure test would have a defined acceptable pressure range, and the device either passes or fails based on direct measurement, not expert consensus or pathology.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

• Not Applicable. (See point 8).

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