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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 (Archloop) 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 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 or 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 device for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 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.

I'm limited to the information provided and cannot determine the acceptance criteria or reported device performance for NIKKISO Co., Ltd.'s Blood Tubing Lines since the text does not contain such details. The document is a 510(k) summary, which outlines the device description, intended use, and technological characteristics, but does not provide specific performance data or acceptance criteria that a study would prove the device meets. The listed "Test Item" reports are general performance tests and do not include the acceptance criteria or the numerical results that would fulfill the criteria. Therefore, I cannot construct the table you requested.

The document states that no animal or clinical performance data was submitted, so a study with a test set, ground truth, or adjudication methods as requested in your prompt was not provided in this 510(k) submission.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Cannot be provided as this information is not present in the document.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no performance study results were provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study results were provided.
4. Adjudication method for the test set: Not applicable, as no performance study results were provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, no clinical performance data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device (blood tubing lines), not an AI algorithm, so this question is not applicable. No standalone performance study results were provided.
7. The type of ground truth used: Not applicable, as no performance study results were provided.
8. The sample size for the training set: Not applicable, as no AI algorithm is involved.
9. How the ground truth for the training set was established: Not applicable, as no AI algorithm is involved.

The document lists various "Test Item" reports (e.g., Sterilization Barrier System Performance Test, Mechanical Hemolysis, Structural Integrity), but these are general performance tests for the device's functionality rather than a study designed to meet specific clinical acceptance criteria. The submission declares that the device is "substantially equivalent" to a predicate device (K082719) based on similar intended use and technological characteristics, with only minor differences that "do not raise new questions of safety and effectiveness." This indicates that the regulatory clearance relies on equivalence to a previously approved device rather than presenting new performance data against specific acceptance criteria.

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