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THIS HEMODIALYSIS BLOOD LINE SET IS CONNECTED TO THE PATIENT AS A DEVICE WHICH WILL EXTRACT THE BLOOD TO THE ARTIFICIAL ORGAN AND PUMPED BACK TO THE PATIENT.

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The provided text describes an FDA 510(k) clearance letter for a medical device called the "Exel I.V. Blood Line Set." This document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria for a new, AI-powered diagnostic device.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics or acceptance thresholds.
• Sample size used for the test set and the data provenance: There's no mention of a test set or its characteristics.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed.
• Adjudication method for the test set: Not applicable as no test set is described.
• 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: This is not an AI-powered device, so such a study is irrelevant here.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for performance evaluation is not discussed.
• The sample size for the training set: Not applicable as it's not an AI device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The document's purpose is to grant marketing clearance based on a finding of "substantial equivalence" to a legally marketed predicate device, as per 21 CFR §876.5820. This process primarily involves comparing the new device's technological characteristics and intended use to an existing, approved device, rather than requiring extensive de novo performance studies with numerical acceptance criteria often seen for novel AI/diagnostic technologies.

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