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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Ethylene Oxide) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

This document is a 510(k) clearance letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)" and "BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series". It focuses on proving substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and study results for a new, innovative AI/software device.

Therefore, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/software device. The questions in the prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the validation of AI/Software as a Medical Device (SaMD), which is not the subject of this 510(k) clearance.

This submission primarily addresses:

• Device Description: Physical components and intended use of blood tubing lines.
• Technological Characteristics: Comparison of materials, design, and sterilization method to a predicate device.
• Bench Testing: Mechanical and functional performance tests for the physical tubing, such as structural integrity, pump segment performance, and resistance to kinking.
• Biological Safety Testing: Biocompatibility tests for materials in contact with blood.
• Sterilization and Shelf Life: Validation of these aspects.

There is no mention of any AI or software components, nor any studies that would involve human readers, ground truth established by experts, or deep learning models, which are the focus of your prompt's questions.

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