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The bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.

The bm25 Blood Monitor Pump is designed for use in Continuous Renal Replacement Therapy

The provided text describes the bm25 Blood Monitor Pump with Ultrafiltration Controller. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, or the other requested information for AI/ML device evaluation.

The document is a 510(k) summary for a medical device (a blood monitor pump), which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance evaluation against specific, quantifiable acceptance criteria.

Therefore, I cannot provide answers to the requested points based on the provided text.

Here's a breakdown of what the document does state regarding validation, but without the requested detail:

Acceptance Criteria and Device Performance (Not explicitly detailed as requested):

• Acceptance Criteria: Not explicitly stated as quantifiable thresholds for specific performance metrics.
• Reported Device Performance:
  "All functions of the bm25 Blood Monitor Pump with Ultrafiltration Controller were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications."
  • Comment: This is a general statement that "specifications were met," but it doesn't provide the actual specification values or the quantitative performance results against those values.

Other Requested Information (Not Available in the Provided Text):

• Sample size used for the test set and the data provenance: Not mentioned. The study appears to be an engineering validation rather than a clinical study with a "test set" in the context of AI/ML.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. "Ground truth" in the context of medical image analysis or similar AI applications isn't relevant here, as this is a hardware device validation.
• Adjudication method for the test set: Not applicable/not mentioned.
• 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 is not an AI/ML diagnostic device.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• The type of ground truth used: Not applicable. The validation likely involved engineering tests and measurements against design parameters.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

What was conducted according to the document:

• Design and material equivalence to the bm11a Blood Monitor Pump.
• Software module distinction between Master and Controller system errors.
• Design to UL2601 - "General electrical safety of medical equipment."
• A fault tree analysis.
• Hazard analysis.
• EMC testing.
• Software System integration validation.

Conclusion:

The provided document describes the safety and equivalence of a physical medical device (a blood monitor pump) through engineering validation and comparison to predicate devices, rather than a performance study for an AI/ML diagnostic tool. Therefore, most of the requested fields, which are specific to AI/ML device evaluation, cannot be answered.

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