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The single use blood tubing set with pre-attached dialyzer is indicated for use with the B. Braun Dialog Series hemodialysis systems for the treatment of acute and chronic renal failure. There are no known contraindications.

The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available B. Braun Dialog Series hemodialysis systems. The device is a single use blood tubing set pre-attached to a high flux (permeability) hollow-fiber dialyzer.

The provided document is a 510(k) Premarket Notification Submission for the NxStage Blood Tubing Set with Pre-Attached Dialyzer. It focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission broadly states that performance, verification, and validation testing was conducted in accordance with the "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions" guidance document issued on April 23, 2008.

Note: The document does not provide specific numerical acceptance criteria (e.g., burst pressure, flow rates) or detailed numerical results for the device's performance. It only offers a general statement that the criteria were met.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Performance, verification and validation testing" without detailing the study design.

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

This information is not provided in the submission. The testing described is non-clinical bench testing, not a clinical study involving expert assessment of patient data.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the submission, as the testing described is non-clinical bench testing.

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

No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a medical device (blood tubing set with dialyzer) and focuses on non-clinical performance and substantial equivalence, not a diagnostic AI algorithm that would involve human reader performance.

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

This is not applicable, as the device is a physical medical device (blood tubing set with dialyzer), not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by the specified test methods and accepted industry standards outlined in the referenced FDA guidance document for hemodialysis blood tubing sets. Compliance with these physical and functional specifications serves as the ground truth for evaluating the device's performance.

8. Sample Size for the Training Set

This is not applicable, as the device is a physical medical device, not an AI algorithm that requires a training set.

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

This is not applicable, as the device is a physical medical device, not an AI algorithm.

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