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The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.

The product is designed for single use only, for an application period of no longer than 6 hours.

Device Description

The Plegiox is a product, which is delivered to the end user in a pyrogen-free and sterile way. The product is determined for single use only. Re-sterilization and re-use are forbidden. The Plegiox is a cardioplegia heat exchanger with integrated bubble trap.

AI/ML Overview

The provided text describes a 510(k) submission for the "Plegiox Cardioplegia Heat Exchanger with and without Safeline Coating" by Maquet Cardiopulmonary AG. The submission asserts substantial equivalence to predicate devices based on in-vitro testing.

However, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and a comprehensive "study" in the way one might expect for a novel device's performance evaluation. The information provided is primarily focused on the device description, indications for use, and a general statement about in-vitro testing for substantial equivalence.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of regulatory submission document.

Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Ability to set and maintain temperature of blood and crystalloid cardioplegic solutions during ECC.	"The Plegiox Cardioplegia Heat Exchanger has shown to be as effective as the predicate device." (Based on in-vitro testing).
Single-use only, for an application period of no longer than 6 hours.	Consistent with predicate device's recommended use period.
(For Safeline Coating) Reduction of surface tension on blood contact surfaces.	Functions with the same intended use as the predicate's Safeline Coating.
Compliance with general safety and effectiveness requirements for cardioplegia heat exchangers.	Demonstrated through in-vitro testing to be substantially equivalent to predicate devices.

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

Sample Size for Test Set: Not specified. The document only mentions "in-vitro testing" without detailing the number of units or test runs conducted.
Data Provenance: The device is manufactured by Maquet Cardiopulmonary AG, Germany. The testing was conducted "in-vitro." Specific details on the lab location or origin of data are not provided beyond the company's location. The testing is assumed to be prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

Number of Experts: Not applicable/not specified. For this type of in-vitro performance test for a physical device, "ground truth" is typically established by engineering standards, validated measurement equipment, and specified test protocols, not by expert consensus on clinical data.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

Adjudication Method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving human interpretation (e.g., imaging reads). For in-vitro engineering tests of a heat exchanger, performance is objectively measured against predefined technical specifications.

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: No. This is a medical device (heat exchanger), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers or AI assistance is not relevant or described.

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

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" would refer to its in-vitro functional capabilities, which were tested.

7. The type of ground truth used

Ground Truth Type: For "in-vitro testing on safety and effectiveness," the "ground truth" would be established by predefined engineering specifications, validated measurement methods, and compliance with industry standards for heat exchange efficiency and material biocompatibility. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This refers to a physical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Ground Truth for Training Set Establishment: Not applicable. As there is no training set for a physical device, this question is not relevant.

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