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The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).

The document provided is a 510(k) summary for the Dimesol Tubing Sets for Hemodialysis. It establishes substantial equivalence to predicate devices rather than proving the device meets explicit acceptance criteria through a standalone study. Therefore, some information typically found in a study demonstrating such criteria (like sample sizes for test/training sets, expert qualifications, or adjudication methods) is not applicable or not provided in the context of this 510(k) submission.

Here is a summary based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit quantitative acceptance criteria with reported numerical performance values in a distinct table, the document refers to compliance with established international standards for various performance characteristics and biocompatibility. The "acceptance criteria" are implied by adherence to these standards and by demonstrating equivalence to predicate devices.

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

The document does not specify the sample sizes used for the tests conducted to demonstrate compliance with ISO standards. It states that tests were performed but does not detail the number of units tested.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. The manufacturing entity is Bain Medical Equipment (Guangzhou) Co., Ltd. in Guangzhou, China. The testing was conducted to international standards (ISO), which are globally recognized.

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

This information is not applicable to a 510(k) submission for a hemodialysis tubing set, as it is a medical device and not an AI/software device that typically requires expert consensus for ground truth establishment. The "ground truth" for demonstrating the safety and effectiveness of this device comes from compliance with recognized performance and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, often seen in diagnostic imaging or AI performance evaluations.

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. The Dimesol Tubing Sets for Hemodialysis are physical medical devices, not an AI or software product. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant for this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device and not an algorithm or AI product.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by compliance with recognized international standards (ISO 10993 for biocompatibility, ISO 8638 and ISO 594-2 for performance) and by demonstrating substantial equivalence to legally marketed predicate devices that have already met these standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no "training set" for this physical medical device.

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