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The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. The information, when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.

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The provided text is a 510(k) clearance letter for the Endotoxin Activity Assay (EAA) device. It does not contain information about acceptance criteria, study details, or performance data of the device. The document primarily focuses on the regulatory clearance process, the device's intended use, and general FDA regulations.

Therefore, I cannot provide the requested information based on the given text. A typical 510(k) submission summary or a separate clinical study report would be required to answer these questions.

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The S.A.M CRRT Unit is intended for:

• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
  For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
  All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
  Rx Only.
  The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.

The S.A.M CRRT Unit is a software controlled device that performs the following functions:

• Primes the SAM disposable cassette automatically.
• Pumps blood through the blood flow path of the disposable cassette.
• Delivers anticoagulant into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use.
• Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
• Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
  The S.A.M CRRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the S.A.M Cassette tubing set.

The provided text describes the 510(k) premarket notification for the S.A.M CRRT Unit, a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). However, the document does not contain information about an AI/ML-driven device, nor does it discuss acceptance criteria and performance data for such a device in the context of diagnostic accuracy, image analysis, or human-in-the-loop studies (MRMC, standalone performance, etc.).

The document focuses on the substantial equivalence of the S.A.M CRRT Unit to a predicate device (Prismaflex K110823) based on its intended use, technological characteristics, and conformance to electrical safety and biocompatibility standards.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) are relevant to the evaluation of AI/ML-powered medical devices, but not to the S.A.M CRRT Unit as described in this 510(k) summary.

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