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Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.

GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.

Citrasate Dry Acid Concentrate product line consists of eight (8) formulations which differ in potassium chloride and calcium chloride mass. These dry components are packaged in four (4) flexible, laminated, sealed, and low-density polyethylene-based bags. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).

GranuFlo Dry Acid Concentrate product line consists of nine (9) formulations which differ in potassium chloride and calcium chloride mass. GranuFlo Dry Acid Concentrate components are packaged in three (3) flexible, laminated, sealed, and low-density polyethylene-based bags. The bags' contents are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products are intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate; sodium diacetate in GranuFlo). Citrasate also contains sodium acetate as a secondary pH adjuster.

Citrasate Dry Acid Concentrate is a single use, non-sterile, device offered in 8 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a four-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).

GranuFlo Dry Acid Concentrate is a single use, non-sterile, device offered in 9 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a three-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

The provided text is a 510(k) Premarket Notification for medical devices (Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate) and does not describe acceptance criteria, performance reports, or studies related to an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for these hemodialysis concentrates.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.

The document describes the following performance data which are relevant to the device's function as a medical concentrate, not an AI/ML algorithm:

• Stability Design Verification: Supported a 24-month (2-year) shelf life through real-time stability evaluations.
• Shipping Verification: Confirmed packaging could withstand distribution based on ASTM D4169-16.
• Biocompatibility Testing: Assessed chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity, and hemocompatibility, along with a toxicological risk assessment.
• Human Factors Validation Testing: Validated for safe and effective use in accordance with FDA guidance.

The document explicitly states:

• "Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are not electrical mechanical devices." for Electrical Safety and Electromagnetic Compatibility.
• "Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate do not contain software." for Software Verification and Validation Testing.
• "No animal studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate." for Animal Studies.
• "No clinical studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate." for Clinical Studies.

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