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The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.

The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.

The provided text describes the Summit Medical Transfusion Filter and its substantial equivalence to a predicate device. It outlines performance testing conducted to demonstrate safety and effectiveness, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with clinical or AI/software validation studies.

Instead, the document focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Pall Biomedical Products Co. SQ40 Blood Transfusion Filter, K960993) by showing it has the "same design principles, made of the same materials, and have the same indications and contraindications for use."

The performance testing mentioned is primarily related to manufacturing quality, biocompatibility, and sterility, which are standard for medical devices.

Therefore, I cannot populate the requested table and answer many of the questions as the specific details are not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The test results achieved demonstrate that the device meets the applicable standards, is biocompatible, and performs in accordance with design specifications." However, it does not provide the specific quantitative acceptance limits or thresholds for each of these tests.

Information Not Found in the Provided Text:

• Sample sizes used for the test set and data provenance: The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data beyond indicating it was performed on the device itself.
• Number of experts used to establish ground truth for the test set and their qualifications: This type of information is relevant for studies involving human interpretation or clinical endpoints. As this is a physical filter, such an expert panel for "ground truth" establishment in a diagnostic sense is not applicable to the reported tests.
• Adjudication method for the test set: Not applicable based on the type of testing described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to a physical transfusion filter. MRMC studies are typically for evaluating diagnostic software or imaging modalities where human readers interpret results.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ISO standards) for material properties, sterility, and biocompatibility.
• Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model requiring training data.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through a comparison of design, materials, and indications for use with a predicate device, supported by standard medical device performance, biocompatibility, and sterility testing. It does not contain evidence of a study designed to validate performance against specific clinical acceptance criteria in a way that would require expert-established ground truth, human reader performance analysis, or AI/algorithm metrics.

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