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The Pal® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency.

The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.

The Pall® Ultipor®U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger is a disposable, highly efficient, bi-directional bacterial/viral filter for patient ventilation solutions and is comprised of the following components:

• . Filter housing - Is comprised of two molded halves, an inlet housing and an outlet housing that are joined and sealed together. The finished filter housing holds the pleated hydrophobic filter media and provides conical (tapered) fittings on opposing sides of the finished housing to provide connection to the conventional equipment used in the breathing circuit. One side of the finished housing has a coaxial conical fitting, with a conical fitting located on the opposing side.
• Hydrophobic filter media Provides airborne bacterial removal efficiency of >99.999%, . airborne viral removal efficiency of >99.995% and waterborne microbial contaminant removal efficiency of 100%. If the filter is used at the patient end, the filter media also acts as a heat and moisture exchanger (HME) by conserving a proportion of the heat and humidity present in the patient's exhaled air and returning it to the patient on the next inspiration.

The provided text is a 510(k) summary for a medical device called the Pall® Ultipor® U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study against human readers or specific clinical outcomes in the way an AI diagnostic device might.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's the information extracted from the provided text, addressing your questions where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.

The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery.

The provided text describes a medical device called "PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System" and its performance data. However, the text does not contain detailed acceptance criteria or a comprehensive study description that directly matches all the requested information for analyzing an AI/ML device.

It's important to note that this document is a 510(k) summary for a traditional medical device (an autotransfusion system), not an AI/ML diagnostic tool. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set" are not applicable or not provided in the context of this device's regulatory submission.

The "Performance Data" section mentions "Bench data" which substantiates claims, but it does not detail the methodology, sample sizes, or a formal study comparing performance against acceptance criteria in the way an AI/ML device would be evaluated.

Given this context, here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the claims made and the compliance with a standard. The reported performance is the "reduction" of certain components. Specific numerical thresholds for "significant reduction" are not provided in this summary.

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

• Sample size: Not specified. The document only mentions "Bench data" without detailing the number of samples or experimental runs.
• Data provenance: Not specified. As "Bench data," it implies laboratory testing, but the country of origin or whether it was retrospective/prospective is not mentioned.

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

Not applicable/Not specified. For this type of device (autotransfusion system), the "ground truth" would likely be based on objective analytical measurements (e.g., laboratory assays for lipids, leukocytes, C3a) rather than expert consensus on images or clinical assessments.

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

Not applicable/Not specified. Adjudication methods are typically used for expert reviews in diagnostic studies, which is not the case here.

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/ML diagnostic device, and thus no MRMC study involving human readers with/without AI assistance would have been conducted or is reported.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and function. The "bench data" would represent the "standalone" performance of the device in a laboratory setting.

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

The document mentions "Bench data substantiates each of these claims." This implies that the ground truth for reduction claims (lipids, leukocytes, C3a) would be established through objective laboratory analytical methods (chemical assays, cell counts, immunological assays, etc.) that measure the levels of these components before and after filtration by the device. It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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Removal by in-line filtration of inadvertent contaminants (including bacteria, particulates, and entrained air) from infused intravenous fluids.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Pall Supor AEF™ Filter." This type of document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The 510(k) clearance process is primarily about demonstrating substantial equivalence to a predicate device already on the market, not about establishing specific performance metrics through detailed studies as would be required for an AI/ML diagnostic or assistive device.

Therefore, I cannot provide the requested information from the given text.

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The Pall STAT-PRIMe Blood Filter for Extracorporcal Service is indicated for use in cardiopulmonary bypass procedures for the removal of microemboli in the arterial return line.

Pall Stat-Prime D Blood Filter for Extracorporeal Service (Featuring the Duroflo® Treatment)

This is a 510(k) premarket notification document for the Pall Stat-Prime D Blood Filter for Extracorporeal Service, indicating FDA clearance. The document itself does not contain a detailed study description with acceptance criteria and device performance results. Instead, it states the "Indications For Use" for the device, which is for the removal of microemboli in the arterial return line during cardiopulmonary bypass procedures.

Therefore, I cannot provide the requested information based on the provided text, as it does not contain the specific study details. This document primarily serves as an FDA clearance letter based on substantial equivalence to a predicate device, rather than a detailed report of a clinical or performance study.

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