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The intended use is to allow access to the central venous system for blood circulation in pheresis or apheresis processes (i.e. Hemodialysis) .

B. Braun of America Inc. intends to introduce into interstate commerce the Braun Diacath Hemodialysis Catheters in lengths of 170 mm and 250mm. These have the same design and performance characteristics.

Here's an analysis of the provided information, focusing on the acceptance criteria and study aspects you requested.

Based on the provided K952660 510(k) summary, it is evident that this document does not describe a study involving an AI or algorithmic device. This 510(k) is for a physical medical device: the Braun Diacath Hemodialysis Catheters.

Therefore, most of your requested information (related to AI performance, ground truth, expert review, sample sizes for AI training/testing, MRMC studies, etc.) is not applicable to this submission.

However, I can extract the information relevant to the safety and effectiveness of this physical device based on the provided text.

Analysis of K952660: Braun Diacath Hemodialysis Catheters

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The document describes the quality control/manufacturing process rather than a specific clinical or performance study with a distinct "test set" as one would expect for an AI device. The proof comes from:

• Internal Quality Control: "All finished products are tested and must meet all required release specifications before distribution."
• Adherence to Established Procedures: "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's."
• Certification of Biocompatibility: A commitment to complete recommended biocompatibility tests.
• Argument for Substantial Equivalence: The primary "proof" for regulatory clearance is the demonstration of substantial equivalence to already marketed devices regarding materials, form, and intended use, with no new safety or effectiveness concerns.

As this is not an AI/algorithmic device, the following points are not applicable (N/A) or cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: N/A (Not an AI device; no separate "test set" in the AI sense involved in this summary). The "test set" here refers to individual finished product units subjected to QC testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth generation by experts for an AI algorithm). Test parameters are defined by internal quality control procedures.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (No expert adjudication for an AI algorithm).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (The "ground truth" for a physical device is its adherence to predefined physical, chemical, and biological specifications and performance parameters, established through standard testing methods, not expert consensus on interpretations).
8. The sample size for the training set: N/A (Not an AI device; no training set in the AI sense).
9. How the ground truth for the training set was established: N/A (Not an AI device).

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