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The Hemodialysis Arterial Blood Tubing Set is intended for use as the extra corporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Arterial Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

The proposed hemodialysis arterial blood tubing sets raise no new issues of safety or efficacy. Sterilization method and packaging are essentially the same. The arterial bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided.

This document is a 510(k) submission, specifically K971313, for a Hemodialysis Arterial Blood Tubing Set. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new device's performance against specific acceptance criteria through a formal study with detailed statistical analysis as would be required for a novel device or AI/software.

Based on the provided text, the device in question is a hemodialysis arterial blood tubing set, which is a physical medical device, not a software or AI algorithm. Therefore, many of the requested elements of your query related to AI/software validation (e.g., test set, training set, ground truth, MRMC study, standalone performance) are not applicable to this submission.

Here's an attempt to answer the relevant questions based on the provided text, and explaining why others are not applicable:

Acceptance Criteria and Device Performance (Based on provided text)

1. A table of acceptance criteria and the reported device performance
See table above. The acceptance criteria are "implied" because 510(k) submissions focus on demonstrating substantial equivalence to a predicate device rather than setting new, explicit, quantitative performance acceptance criteria in the same way a de novo device might. The "performance" here largely refers to the device meeting the same safety and efficacy profile as the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a physical medical device (blood tubing set), not a software or AI device. The text indicates "functional testing" and "biocompatibility testing," but does not provide details on sample sizes or data provenance for these tests. These are standard engineering and materials tests, not clinical studies in the typical sense that would have test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of "experts" to establish "ground truth" for a "test set" as would be relevant for an AI/software device. The validation involves standard engineering and biocompatibility testing for a physical component.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as this is not an AI/software device with a medical imaging or diagnostic component.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of AI/software. For a physical device, "ground truth" would be established by validated test methods for functionality, material properties, and sterility, compared against established standards or predicate device performance. The text mentions "functional testing" and "biocompatibility testing" data were provided.

8. The sample size for the training set
Not applicable. This is not an AI device.

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

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The Hemodialysis Venous Blood Tubing Set is intended for use as the extracorporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

The proposed hemodialysis venous blood tubing sets raise no new issues of safety or effectiveness. No new claims or indications are made. The venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the venous bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided. Sterilization method and packaging are the same as the predicate devices.

The provided text does not contain information about the acceptance criteria and study particulars for a medical device in the context of an AI/ML or comparative effectiveness study. The document is a 510(k) summary for a hemodialysis venous blood tubing set, which is a physical medical device, not a diagnostic AI tool.

The document discusses:

• The substantial equivalence of the blood tubing set to existing legally marketed bloodlines.
• Functional testing of the bloodlines.
• Biocompatibility testing of blood contact materials.
• Integrity testing of bonded connections.
• Sterilization method and packaging being the same as predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design details for AI/ML, sample sizes, expert qualifications, or ground truth establishment. These concepts are not applicable to the context of this 510(k) submission.

Ask a specific question about this device