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The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.

The provided text describes a 510(k) submission for the Haemonetics® 40µ RBC Filter Bag. While it states that performance testing was conducted, it does not provide specific acceptance criteria or details about the study that proves the device meets them in the format requested.

Here's an breakdown of the information that is available and what is missing:

The document confirms that "Haemonetics has conducted testing to verify the safety and performance of the 40u RBC Filter Bag. A detailed list with summaries of testing is provided with the test protocols and reports." However, these detailed lists, summaries, protocols, and reports are not included in the provided text.

Therefore, many of the requested details cannot be extracted from the given input.

Here's what can be gathered and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The text mentions the filter is for "microaggregates greater than 40 microns," which implies a filtration efficiency criterion, but no specific percentage or threshold is given.
• Reported Device Performance: Not explicitly stated in the provided text beyond the general statement of testing for "safety and performance."

2. Sample size used for the test set and the data provenance

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The device is a filter, and its performance would likely be assessed through laboratory testing (e.g., particle counting, flow rates) rather than expert review of images or clinical cases that require ground truth from human experts.

4. Adjudication method for the test set

• Not applicable/not provided. See point 3.

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 device is a physical filter, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

• Since the device filters particles greater than 40 microns, the ground truth would likely be established through physical measurements of particle size and count before and after filtration, using methods like microscopy or automated particle counters. However, the specific type of ground truth used is not specified in the provided text.

8. The sample size for the training set

• Not applicable. This device is a physical filter. It does not use a "training set" in the context of machine learning or AI. Testing would involve a specific number of filter units tested under defined conditions. This number is not provided.

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

• Not applicable (see point 8).

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence to a predicate device for regulatory approval. It mentions that performance testing was conducted, but it does not include the details of those tests, such as specific acceptance criteria or the study results, that would fulfill your request. These details would typically be found in the accompanying test protocols and reports referenced within the document but not included in your input.

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