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The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.

The provided document is a 510(k) premarket notification for a medical device, the Dideco DHF Hemoconcentrator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.

Therefore, many of the requested points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or
not explicitly detailed in this type of submission. The 'acceptance criteria' here refer to the performance specifications the device must meet to be considered equivalent to existing devices and safe for its intended use.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance for Dideco DHF Hemoconcentrator

The Dideco DHF Hemoconcentrator underwent non-clinical and in vitro testing to demonstrate compliance with safety and effectiveness requirements and substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical values or ranges. Instead, it states that the results of the tests "met established specifications" and showed "comparable or even better performances" with respect to the predicate devices. The types of performance criteria evaluated are listed.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or repeat tests performed for each in vitro and non-clinical test. It states "The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications." This implies multiple units of each model were tested.
• Data Provenance: Not explicitly stated, but based on the submitter's location (Italy) and adherence to international (ISO, EN) and US (FDA) standards, the testing was likely conducted in a laboratory setting, potentially in Italy or a contracted facility. The data is retrospective in the sense that the tests were performed before the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This is a medical device (hardware) submission focused on physical and biological performance characteristics, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" here is determined by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like '2+1' or '3+1' are typically used for establishing ground truth in image interpretation or diagnostic studies, which is not applicable to the in vitro and non-clinical testing of a hemoconcentrator.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. The Dideco DHF Hemoconcentrator is a physical device used during cardiopulmonary bypass; it is not an AI/software tool, and human interpretation of outputs in the clinical context is not evaluated in this way in this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. The device is a physical hemoconcentrator. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties and performance without human interaction as part of the test itself (though a human operates the test equipment).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established through:

• Established Specifications/Standards: Reference to ISO 10993-1:1997, FDA May 1, 1995 Memorandum, FDA "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" (1998), and EN 1283:1996 when applicable. These documents define the accepted test methods and, implicitly or explicitly, the performance thresholds for safety and effectiveness.
• Predicate Device Performance: The primary comparative "ground truth" was the established performance of the legally marketed predicate devices (Cobe HC 700 Midi Hemoconcentrator (K003023) and Hemocor HPH 400 Hemoconcentrator (K923139)). The new device was deemed acceptable if its performance was "comparable or even better" than these predicates.
• Objective Measurements: Laboratory measurements of physical properties (priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity) and biological indicators (plasma free hemoglobin, index of hemolysis) against predefined limits.

8. Sample Size for the Training Set

N/A. This submission does not involve a "training set" as it is not an AI/machine learning device. The tests are for device validation, not model training.

9. How the Ground Truth for the Training Set Was Established

N/A. See point 8.

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