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The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-102DB、BT-102DC、BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-102DA 、BT-102DB、BT-102DC、BT-102DD)

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way requested for AI/diagnostic devices. The information provided heavily emphasizes physical, chemical, biological, and sterilization specifications rather than clinical performance metrics often associated with "device performance" in the context of diagnostic or AI-driven tools.

Therefore, the requested table of acceptance criteria and reported device performance, and several other points (2, 3, 4, 5, 6, 7, 8, 9), cannot be directly extracted or are not applicable from the provided text in the way they would be for a typical AI/diagnostic device study. The text primarily focuses on conformity to standards and substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench testing," but it does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood tubing pack, and its evaluation relies on engineering, material, and sterility testing against established standards, not expert interpretation of outputs like an AI diagnostic tool.

4. Adjudication method for the test set
Not applicable. The evaluation is based on conformance to engineering and safety standards, not a diagnostic interpretation process requiring adjudication.

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
Not applicable. This is not an AI or diagnostic device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation focuses on the physical and biological characteristics of the blood tubing pack itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established international and national standards for medical device safety, material compatibility, and sterilization (e.g., ISO 10993 series for biological evaluation, ISO 11607-1 for packaging, ISO 11135 for sterilization, USP Pyrogenic standards).

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.

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