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The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.

The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide. The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.

The provided text describes a 510(k) submission for the "Venous Bubble Trap with and without Bioline Coating." The study described is a non-clinical study focused on demonstrating substantial equivalence to predicate devices, rather than a clinical trial with specific performance metrics against an acceptance criterion in the way modern AI/ML device studies are conducted.

Here's a breakdown based on the provided information, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Testing and evaluation on safety and effectiveness was executed to demonstrate that the Venous Bubble Trap with and without Bioline Coating described in this submission is substantially equivalent to the Capiox Bubble Trap from Terumo Medical Corp. as a bubble trap as well as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the coating." This indicates that the acceptance criterion was substantial equivalence to the predicate devices across these tested areas. Specific quantitative acceptance values (e.g., "bubble removal efficiency > X%") are not provided in this summary but would have been part of the underlying test protocols that supported the substantial equivalence claim. The reported performance is that it met these criteria, thus supporting the substantial equivalence.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified. This was a non-clinical (bench) testing, so there is no patient data provenance.

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

• This information is not applicable and not provided for this type of non-clinical device testing. Ground truth for device performance features like integrity, performance (bubble separation), stability of coating, biocompatibility, and sterility would be established through established scientific and engineering test methods and standards, not through expert consensus in the way a diagnostic AI would use medical expert labels.

4. Adjudication Method for the Test Set

• Not applicable for this type of non-clinical device testing. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical bubble trap, not an AI or imaging device that would typically involve human readers.

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

• This question is not applicable. The device is a physical bubble trap, not an algorithm. The "performance" assessment would have been a standalone test of the physical device's ability to remove bubbles.

7. The Type of Ground Truth Used

• For "Integrity," "Performance," "Stability of the Coating," "Biocompatibility," and "Sterility," the ground truth would have been established through validated laboratory testing methods and engineering specifications. For example, "Performance" (bubble removal) would be measured against a defined standard for air volume or bubble size removed, which would serve as the ground truth. "Biocompatibility" would be assessed according to ISO standards, with the "ground truth" being compliance with those standards.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for a physical device.

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The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: 1) Venous return; 2) Intracardiac suction; 3) Ventricular vent devices; 4) Arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Bard Quantum CVR) and a statement of its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a detailed premarket submission summary.

Therefore, I cannot extract the requested information from the given input.

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The Dideco D920, Lilliput I twin reservoir is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuumassisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir, as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return. Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

The D 920 serves as a collection reservoir for venous blood recovered by intracardiac sucker and ventricular vent devices. The D 920 device can also be attached to an oxygenator, previously cleared by the Agency for the same patient population, in order to collect blood during normal operations, assuring the proper oxygenation capability of the device is currently being developed in an open system configuration which includes the Dideco D901 Lilliput oxygenator, cleared by the Agency on March 15th 1996 (K953835).

The hard-shell cardiotomy/venous reservoirs are comprised of a rigid polycarbonate housing with an internal support; in which a filtering system is placed around the support. The D 920 has two distinct (upper and lower) sections connected by an overflow system. The upper section contains a defoamer sponge and screen filter which are designed to remove microaggregates and microemboli from cardiotomy suction and vent blood. The devices are available with a 30 micron filter. The venous return blood enters the lower section and passes through a defoamer sponge. Only the lower section is contained within a polyester outer screen.

The D 920 has four cardiotomy suction/vent inlet ports which accommodate both 1/4 and 3/16" inner diameter tubing. Three priming ports are positioned on the top of the reservoir: 3 x luer lock (filtered), 1 x luer lock (unfiltered) and 1 x 1/4-3/16". Fluid added through the one outer priming port bypasses the integral cardiotomy section. Fluids added through the three inner luer and 1/4-3/16" ports flow through the defoamer and filter elements in the cardiotomy section. Venous blood enters through the 1/4-3/16" inlet port at the bottom of the unit. The D 920 has a 1/4-3/16" blood outlet port at the bottom of the unit. The 1/4" gas outlet port is located at the top of the unit. Both devices are supported by a holder.

The provided text describes a 510(k) premarket notification for the Dideco D920, Lilliput 1 twin reservoir, a medical device for infant cardiopulmonary bypass surgery. However, the document does not present a formal study with acceptance criteria and device performance metrics in the way that would typically be seen for a new, substantially different device.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (VENOMIDICARD/MIDICARD and MICRO SAFE). This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with standard biocompatibility and in vitro performance testing.

Therefore, many of the specific questions about sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission focusing on substantial equivalence based on predicate devices.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this 510(k) is primarily centered on demonstrating similar safety and effectiveness to the predicate devices. The "performance" is shown through direct comparisons of technical specifications and an assertion of similar operating principles.

Note: The "acceptance criteria" in the table are inferred from the 510(k) process for substantial equivalence. The goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to meet specific numerical targets beyond what the predicates achieve.

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

This information is not provided in the document. For a 510(k) based on substantial equivalence, specific "test sets" with clinical outcome data in the sense of a new clinical trial are typically not required unless there are significant technological differences or new indications. The performance data mentioned (biocompatibility, in vitro performance) would be conducted on device samples, but the number of samples is not specified, nor is the "data provenance" in terms of patient cohorts. These are laboratory/bench tests.

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

This is not applicable as there is no mention of a clinical "test set" requiring expert ground truth establishment for diagnostic or prognostic accuracy. The testing performed (biocompatibility, in vitro performance) relies on standardized laboratory procedures.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study focuses on human reader performance, often with and without AI assistance, which is typically for diagnostic imaging devices. The Dideco D920 is a physical medical device (venous cardiotomy reservoir), not a diagnostic or AI-powered system, so an MRMC study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. The Dideco D920 is a physical medical device, not an algorithm or AI system, so the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the biocompatibility testing, the "ground truth" would be the established safety profiles outlined in ISO 10993-1:1992 and FDA guidance, ensuring the device materials are not toxic or harmful.
For the in vitro performance testing (based on ISO 7199), the "ground truth" would be the predefined performance specifications and test methods in the standard, demonstrating the device's functional integrity (e.g., flow rates, filtration efficiency under simulated conditions).

8. The Sample Size for the Training Set

Not Applicable. As the Dideco D920 is a physical medical device and not an AI/machine learning system, there is no "training set."

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

Not Applicable (as there is no training set).

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The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: (1) venous return (2) intracardiac suction (3) ventricular vent devices (4) arterial-venous shunts It defoams, filters and stores this blood before returning it to the circuit.

The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: (1) venous return (2) intracardiac suction (3) ventricular vent devices (4) arterial-venous shunts It defoams, filters and stores this blood before returning it to the circuit.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text only discusses the "Bard® Quantum™ CVR" and its comparison to predicate devices, focusing on the equivalence of its technological characteristics and performance. It does not provide specific numerical acceptance criteria for a new AI/ML device or its reported performance in those terms. Instead, it states:

2. Sample Size and Data Provenance for Test Set:

This document describes a comparison between a new medical device (Bard® Quantum™ CVR) and predicate devices, not an AI/ML system. Therefore, the concept of a "test set" with specific sample sizes from different countries or retrospective/prospective data as used in the context of AI/ML is not directly applicable. The "test set" here refers to the actual physical devices (Bard H6770VR, Cobe HVRF, and Bard H-3700) that underwent bench testing. The provenance isn't specified beyond the manufacturer.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable. The "ground truth" for this medical device is established through physical and chemical performance tests (e.g., measuring cell damage, defoaming ability, filtration efficiency, and biocompatibility) performed in a lab setting, not through expert human interpretation of data.

4. Adjudication Method for Test Set:

Not applicable. There's no human interpretation or adjudication process described for the performance testing. The results are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device, not an AI/ML system that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an algorithm or AI system, so the concept of standalone algorithm performance is irrelevant.

7. Type of Ground Truth Used:

The ground truth for this device's performance was based on bench testing results (objective measurements of cell damage, defoaming ability, filtration efficiency) and biocompatibility testing standards (ISO 10993).

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for such a device is its engineering design and manufacturing process.

9. How Ground Truth for Training Set Was Established:

Not applicable. There is no training set as this is not an AI/ML device.

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