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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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