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The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used.

This document describes a 510(k) premarket notification for the MAQUET BC 60 plus and BC 140 plus Hemoconcentrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific training set details, and type of ground truth used) are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the format of acceptance criteria and reported performance values. The submission states that the devices met the requirements of ISO standards and that evaluation and testing demonstrated substantial equivalence. However, the specific quantitative acceptance criteria or the reported performance data against those criteria are not detailed in this public FDA summary. The assessment revolves around equivalence to predicate devices, not the new establishment of performance criteria for this specific device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission states that "evaluation and testing on safety and effectiveness was executed" and lists general areas (Integrity, Performance, Biocompatibility, Sterility) that were tested/evaluated. However, details about sample sizes, study design (retrospective/prospective), or data provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable/not provided. This type of information is typically relevant for studies evaluating diagnostic or AI-driven devices where human expert consensus forms a "ground truth" for comparison. Hemoconcentrators are physical medical devices, and their performance is assessed through engineering and biological testing, not through expert interpretation of data points that require "ground truth" establishment in the way an image analysis algorithm might.

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

This is not applicable/not provided for the same reasons as item 3. Adjudication methods are used in studies involving human interpretation or subjective assessments to resolve discrepancies, which is not the primary method for evaluating the performance of a physical device like a hemoconcentrator.

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

This is not applicable/not provided. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a hemoconcentrator, not a diagnostic imaging or AI system.

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

This is not applicable/not provided. This question pertains to AI algorithms. The MAQUET Hemoconcentrators are physical devices that perform a function and are not AI algorithms.

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

As noted previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to the evaluation of a hemoconcentrator. The "truth" in this context would be the objective measurements of the device's technical performance and biological safety as defined by the relevant ISO standards and predicate device performance. For biocompatibility, established biological endpoints and validated testing methods would constitute the "ground truth."

8. The sample size for the training set

This is not applicable/not provided. This question applies to machine learning models. The MAQUET Hemoconcentrators are physical medical devices, not an AI algorithm that requires a training set.

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

This is not applicable/not provided for the same reason as item 8.

Summary of the Study and Device Evaluation:

The study proving the device meets criteria for substantial equivalence (which is the regulatory standard for this 510(k) submission) is based on non-clinical testing.

• Acceptance Criteria/Performance Standards: The devices were tested to and met the requirements of:

  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing. (This implies meeting established biocompatibility endpoints).
  • ISO 8637: Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. (This implies meeting established performance and safety requirements for these types of devices).
  • The overall "acceptance criteria" were demonstrating substantial equivalence in safety and effectiveness to the predicate devices: Hemocor HPH® 700 (K983085) and Hemocor HPH® 1400 (K923139). This equivalence was assessed across the "principals of operation, performance and indications for use."

• Areas Tested/Evaluated:

  • Integrity
  • Performance
  • Biocompatibility
  • Sterility

Limitations of the provided text: This 510(k) summary is a high-level overview. It confirms that testing was done and standards were met, but it does not provide the detailed results, specific test protocols, or quantitative data that would fulfill many of the requested items (e.g., exact performance numbers, sample sizes, or specific ground truth methodologies for each test). The purpose of this summary is to demonstrate regulatory compliance through substantial equivalence, not to provide a detailed scientific publication of a study's methodology and results.

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