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The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours: The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field of cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The Neonatal and Pediatric Reservoirs may be applied during the surgery in the extracorporeal circulation for collecting venous blood by gravitation or vacuum assist venous drainage (VAVD), air removal in venous blood, as a volume depot of blood, for collecting, defoaming and filtering cardiotomy blood. The Reservoirs may also be applied after the surgery on the intensive care unit for vacuum operated thoracic drainage and for the autotransfusion of autologous blood. If the application occurs in the intensive care unit the reservoir which was employed in the operation is usually used. The blood contacting surfaces are coated optionally with SOFTLINE Coating. The Neonatal and Pediatric Reservoirs are sterile and non-pyrogenic devices, for single use only and are not to be re-sterilized by the user.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for a device's performance metrics (e.g., "filtration efficiency must be >X%"). Instead, the acceptance criteria are framed as compliance with recognized standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially a statement of compliance.

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

The document does not specify a sample size for any "test set" in the traditional sense of a clinical trial or large-scale device performance study. The testing described is primarily laboratory and bench testing against international standards (ISO 10993-1, ISO 15674) and direct comparison to a predicate device.

• Sample Size: Not specified.
• Data Provenance: The studies were likely conducted internally by the manufacturer (Maquet Cardiopulmonary AG) or by contracted laboratories, as part of the regulatory submission process.
• Retrospective or Prospective: Not explicitly stated, but typically, this type of non-clinical testing is prospective, meaning it's conducted specifically to support the 510(k) submission. There is no indication of patient data being used in this summary.

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

This information is not applicable and not provided in the document. The "ground truth" for this medical device (a cardiotomy reservoir) is established by adherence to recognized engineering standards (e.g., ISO) and functional performance metrics, not by expert interpretation of data like in an AI/diagnostic imaging context. The "experts" involved would be engineers, biocompatibility specialists, and quality control personnel performing the tests according to standard protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., reading medical images) where there can be disagreement among experts. For device performance testing against objective standards (like ISO norms for a physical device), the results are typically quantitative measurements that either pass or fail the specified criteria, not subjective interpretations requiring adjudication.

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 information is not applicable and not provided. This document describes a physical medical device (a blood reservoir) and its regulatory clearance based on substantial equivalence and compliance with standards. It is not an AI algorithm or a diagnostic imaging device that would involve human readers or AI assistance.

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

This information is not applicable and not provided. The device is a physical hard-shell cardiotomy reservoir, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Compliance with International Standards: Specifically ISO 10993-1 (Biologic Evaluation) and ISO 15674 (Hard-shell cardiotomy/venous reservoir systems). These standards define performance characteristics, safety requirements, and test methods.
• Comparison to Predicate Devices: Demonstrating that the new device performs as safely and effectively as legally marketed predicate devices (Capiox Reservoir RX 05 Baby and Resevoir D101 Dideco Kids Infant) in terms of indications for use, integrity, performance, biocompatibility, and sterility.

No pathology, expert consensus, or outcomes data from patients are mentioned for establishing the "ground truth" of the device itself for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. Since there is no training set for an AI model, there's no ground truth established in this context.

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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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