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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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The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped. There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for the test set. However, it indicates that "Comparative in vitro testing" was performed on the Fresenius F40, F50, F70, and F80 hemoconcentrators. This suggests a test set comprising various models of the subject device.

The data provenance is in vitro testing. The country of origin of the data is not explicitly stated, but given that Fresenius USA submitted the 510(k), it is likely the testing was conducted in the US or by a facility associated with Fresenius USA. The testing was prospective as it was conducted to characterize the performance of the new devices.

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

This information is not provided in the document. The study focuses on in vitro performance comparison, which typically relies on established laboratory measurement techniques and standards rather than expert human interpretation for raw data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As explained above, the study involved in vitro testing and performance measurements, not expert human assessment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study described is an in vitro performance comparison of the device itself, not an evaluation of human readers (clinicians) using the device with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

N/A. The device is a medical apparatus (hemoconcentrator), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable in this context. The study did evaluate the standalone performance of the device in vitro.

7. The Type of Ground Truth Used

The ground truth used was established laboratory measurements and scientific principles. Specifically, performance characteristics were measured against:

• Draft specifications for the products.
• A recognized international standard, EN 1283, Haemodialyzers, Haemodiafilters, Haemoconcentrators and Their Extracorporeal Circuits.
• Performance of legally marketed predicate devices (F40, F60, Bard HC40, Amicon Diafilter 30, Minntech Hemocor HPH 1000, Baxter Bentley Quick Prime HQ 7000, Research Medical Biofilter 140) under similar operating conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The term "training set" doesn't apply to the development or evaluation of this type of product.

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

This information is not applicable as there is no training set for this type of device.

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The CAPIOX Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.

It is intended to be used during and after surgical procedures requiring cardiopulmonary bypass (up to 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.

CAPIOX® Hemoconcentrator consists of Glycerin-free polysulfone fibers, casing, blood port, O-ring and adhesives.

The hemoconcentrator is available in two model has a total membrane area I he nemoconcentrator is a valuable in a 1.08 m² surface area.

Three types of blood ports are available in each model: ¼" slip, 3/16" slip, and 3/16" The ports are transparent allowing easy observation of air bubbles passing through the ports when priming.

Dimensions of filtrate ports meet the requirements specified in ISO 8637 which permits connection of fast couplings.

The CAPIOX Hemoconcentuator provides high ultra filtration rates which permits the The CAPIOX Hemoval of excess fluid by a slight hydrostatic pressure differential across the membrane without loss of essential plasma proteins

The provided text describes the CAPIOX® Hemoconcentrator, a device intended to remove excess fluid from blood during and after cardiopulmonary bypass. The document is a Summary of Safety and Effectiveness Information submitted as part of a 510(k) submission (K973516) to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

• Acceptance Criteria for Device Performance: The acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device (Minntech Hemocor HPH Hemoconcentrator) across several key characteristics. The study proving this substantial equivalence is a comparative analysis, rather than a traditional clinical trial with a defined test set and ground truth in the context of AI/machine learning.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable in the context of an AI/ML test set. The study demonstrating substantial equivalence is a comparison of specifications and design, not an evaluation on a patient-data test set.
• Data Provenance: Not applicable. The "data" here are the specifications and design features of the device itself and the predicate device, not patient data.

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

• Number of Experts/Qualifications: Not applicable for establishing ground truth in an AI/ML sense. The "ground truth" is the established performance and safety profile of the predicate device, which is implied to be acceptable based on its prior market clearance. The comparison was conducted by the manufacturer, Terumo Medical Corporation, with regulatory oversight by the FDA.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This was a direct comparison of specifications and design, not a judgment of performance on a data set.

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:

• MRMC Study/Effect Size: No. This document describes a medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

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

• Standalone Performance: No. This is a standalone medical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: The "ground truth" used for this submission is the established performance and safety profile of the legally marketed predicate device (Minntech Hemocor HPH Hemoconcentrator). The acceptance criteria essentially state that the new device must be sufficiently similar to the predicate device such that it does not raise new questions of safety or effectiveness. This is determined by comparing intended use, design and materials, technology/principles of operation, specifications, and performance.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.

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