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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.

Ask a specific question about this device

The bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.

The bm11a Blood Monitor Pump is designed for use in the following extracorporeal therapies:

• Continuous Venovenous Hemofiltration (CVVH)
• Continuous Venovenous Hemodiafiltration (CVVHD)
• Slow Continuous Ultrafiltration (SCUF)

The provided text describes a 510(k) summary for the bm11a Blood Monitor Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness, rather than reporting on a study with acceptance criteria and device performance in the way a clinical trial might for a diagnostic AI device.

Therefore, the requested information cannot be fully extracted in the format requested as the submission pertains to a different type of device (a pump) and evaluation process. However, based on the available information, here's what can be gathered, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "design specifications" and "required specifications" but does not explicitly list them or their corresponding performance metrics in a table. The summary states: "All functions of the bm11a Blood Monitor Pump were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications."

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

Not applicable. The testing described is functional validation of a pump, not a diagnostic device using a "test set" of patient data. The validation was conducted on the device itself.

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

Not applicable. Ground truth, in the context of device performance for this pump, refers to engineering and functional specifications, not a medical "ground truth" established by experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for expert review of images or data in a diagnostic study.

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

No. This device is a blood monitor pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

Not applicable. This device is a physical pump. The "standalone" performance would be its functional operation in a clinical setting, which is implicitly covered by the "all functions...meet their respective required specifications."

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be its design specifications and engineering requirements for flow rates, safety mechanisms, electrical performance, etc. The document mentions "UL2601 - General electrical safety of medical equipment," "fault tree, hazard analysis, EMC testing, and software System integration validation" as methods used to assess compliance with these requirements.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. No training set is mentioned or relevant for this device.

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