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The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.

Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy.

The provided text for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930) discusses performance in terms of adherence to various standards rather than specific quantitative acceptance criteria and device performance values. It is a submission for a medical device that outlines its equivalence to a predicate device based on similar intended use and technological characteristics. The document does not describe a study comparing the device's performance against specific, pre-defined quantitative acceptance criteria in a clinical setting in the way an AI/ML device would be.

Therefore, many of the requested categories for AI/ML device studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this 510(k) summary for a physical medical device.

However, I can extract the information that is present and indicate where the requested information is not provided or applicable.

Acceptance Criteria and Device Performance for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930)

This 510(k) summary for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET does not present quantitative acceptance criteria or corresponding device performance results in the format typically seen for AI/ML diagnostic devices. Instead, the performance is demonstrated through conformance to established national and international standards for physical medical devices. The core argument for acceptance is substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study described is primarily a bench testing and comparison to predicate device approach, rather than a clinical trial with quantitative endpoints in the context of AI/ML performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to "bench testing," which implies laboratory-based evaluations of the physical device components. Specific sample sizes for these tests are not provided in this summary.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. The testing would have been conducted in a laboratory setting by the manufacturer, BIOTEQUE CORPORATION, likely in Taiwan (R.O.C.), given the submitter's address.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., radiologists reviewing images to establish ground truth). For a physical medical device like blood tubing, "ground truth" is typically established through validated laboratory tests against defined physical, chemical, and biological specifications, not through expert consensus on observational data.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth from observational data. This is not relevant for bench testing of a physical product.

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 a physical medical device (blood tubing), not an AI/ML diagnostic algorithm. Therefore, an MRMC study and the concept of human reader improvement with/without AI assistance do not apply.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Standards Conformance: The "ground truth" for this device is based on conformance to established national and international standards for medical device physical, chemical, biological, and sterilization properties (e.g., ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards). The absence of safety and effectiveness concerns compared to a predicate device (K853851) also serves as a benchmark for acceptability.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.

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