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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.

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.

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

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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The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.

This document describes a 510(k) submission for a medical device modification, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like "test set," "ground truth," "MRMC study," "human readers," and "training set" are not applicable.

The submission focuses on demonstrating substantial equivalence of a modified medical device to existing predicate devices.

Here's an analysis of the provided text in the context of the questions that are applicable:

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

The document does not provide a table with specific acceptance criteria or quantitative performance metrics in the way one would expect for an AI/ML model. Instead, it states that the device was evaluated for "safety and effectiveness" and that the data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices."

The evaluation areas mentioned are:

• Integrity
• Performance
• Biocompatibility
• Sterility

No specific performance thresholds or detailed results are reported in this summary. The "performance" assessment refers to the device's functional integrity and ability to perform its intended purpose (collecting, storing, and filtering blood) without adverse effects compared to the predicate.

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

Not applicable in the context of an AI/ML model's test set. This submission refers to a medical device modification (adding a coating). The "testing" here refers to standard medical device verification and validation activities (e.g., bench testing, biocompatibility studies). The document does not specify sample sizes for these tests, nor their provenance as would be relevant for a data-driven model. The submitter is Maquet Cardiopulmonary AG from Germany.

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)

Not applicable. There is no concept of "ground truth" or "experts" establishing it in the context of this device modification. The evaluation is based on standard engineering and biological testing against established specifications or predicate device performance.

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

Not applicable. This concept is relevant for AI/ML models where human disagreement on ground truth might occur.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable for an AI/ML model. For this device, "ground truth" would be established specifications, regulatory requirements, and the performance characteristics of the predicate device. For example, "sterility" ground truth would be a validated sterile state, "biocompatibility" would be a state of not causing adverse biological reactions, and "integrity" would be a state of structural soundness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no "training set."

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

Not applicable. This is not an AI/ML device. There is no "training set" or corresponding ground truth.

Summary for K061743: Device Modification - Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

This 510(k) submission is for a modification to an existing medical device, the Jostra Venous Hardshell Cardiotomy Reservoirs, by adding a "Safeline Coating." The submission aims to demonstrate substantial equivalence to predicate devices. It is not an AI/ML enabled device, therefore many of the requested criteria related to AI/ML performance evaluation are not applicable.

The core of the study is a comparison to predicate devices, showing that the modified device is "the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs," with the only difference being the Safeline coating. The coating itself is also stated as being the same as already cleared for the Jostra RotaFlow Centrifugal Pump (K061072).

The "study" refers to the evaluation and testing conducted to demonstrate safety and effectiveness, leading to the conclusion of substantial equivalence.

Applicable Information:

• Acceptance Criteria & Reported Device Performance: General acceptance of "safety and effectiveness" through demonstration of substantial equivalence to predicate devices (Jostra Venous Hardshell Cardiotomy Reservoirs and Jostra RotaFlow Centrifugal Pump with Safeline Coating).

  • Evaluation Areas: Integrity, Performance, Biocompatibility, Sterility.
  • Reported Performance: The data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices." No specific quantitative performance metrics are provided in the summary, as the focus is on equivalence.

• Sample Size and Data Provenance: Not explicitly detailed in the summary for individual tests (e.g., "N=XX samples tested for biocompatibility"). The device manufacturer is Maquet Cardiopulmonary AG, Germany. The testing would be prospective validation of the modified device.

• Ground Truth: For non-AI/ML devices, "ground truth" refers to recognized standards, established specifications, and the performance of legally marketed predicate devices. The modified device's performance across the evaluation areas (integrity, performance, biocompatibility, sterility) would be measured against these benchmarks.

Non-Applicable Information (for this type of device submission):

• Test set/Training set sample sizes
• Number/Qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone (algorithm-only) performance
• Specific types of ground truth (e.g., pathology, outcomes data relevant to AI diagnostics)

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