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tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system.

B. Braun Medical Inc. intends to introduce into interstate commerce the Braun Hemodialysis Blood Circuits in various configurations. The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system. The various configurations account for user preferences and various hemodialysis systems currently marketed. These all have the similar design and performance characteristics.

This document is a 510(k) premarket notification for a medical device submitted in 1996. It does not contain the type of detailed information typically found in modern AI/ML device submissions regarding acceptance criteria, performance studies, or ground truth establishment for software algorithms.

The document describes a physical medical device (Hemodialysis Blood Circuits) and focuses on demonstrating substantial equivalence to a predicate device and adherence to manufacturing and testing standards. Therefore, most of the requested information regarding AI/ML device evaluation is not applicable or present in this text.

However, I can extract the relevant information from the provided text according to your request, highlighting where the information is absent due to the nature of the device and the submission.

Here's the analysis of the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, specific quantitative acceptance criteria and reported device performance in a table format are not explicitly stated beyond general statements about meeting "required release specifications" and "product design specifications." The document refers to internal "Quality Control Test Procedure documents" and "Device Master Records" that define these.

The document indicates that testing includes:

• Sterility
• Pyrogenicity (endotoxin/LAL Method)
• Physical testing
• Visual examination (in process and finished product)

It also states: "All finished products are tested and must meet all required release specifications before distribution." And refers to "recommended performance standards outlined by The Association for the Advancement of Medical Instrumentation in the draft standard AAMI RD17R-6/94."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described pertains to manufacturing quality control for physical devices, not a clinical performance study using a test set of patient data.

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)

This information is not applicable and not provided. The device is a physical hemodialysis blood circuit. The "ground truth" here would be defined by manufacturing specifications and performance standards, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of the testing described for this physical device.

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

This information is not applicable and not provided. The device is a physical hemodialysis blood circuit, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable and not provided. The device is a physical hemodialysis blood circuit, not a software algorithm.

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

The "ground truth" or standard for compliance appears to be based on:

• Product design specifications (as defined in "Device Master Records").
• Established testing procedures and parameters ("Quality Control Test Procedure documents").
• Recommended performance standards outlined by AAMI (The Association for the Advancement of Medical Instrumentation in the draft standard AAMI RD17R-6/94).

For biocompatibility, the "Tripartite Guidance for this category of contact duration" is mentioned.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical hemodialysis blood circuit, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. The device is a physical hemodialysis blood circuit, not an AI/ML model.

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