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The SMARXT® BMR1900™ Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT BMR1900 Closed Venous Reservoir Bag is a sterile device with a non-pyrogenic fluid pathway, for single use only, and is not intended to be resterilized by the user. The device is a soft-shelled blood reservoir designed for use in cardiopulmonary bypass surgery for periods up to six hours. The SMARxT BMR1900 can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL. The SMARxT BMR1900 has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. The top edge of the bag has a dual four-way stopcock assembly that is used to purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. Blood enters the bag through the inlet port and passes through a polyester screen filter before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood.

The provided text is a 510(k) summary for the SMARxT® BMR1900™ Closed Venous Reservoir Bag. This document focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical characteristics and in-vitro test data. It does not describe a study involving "acceptance criteria" for an AI-powered device, "reported device performance" in the context of diagnostic accuracy, "sample sizes for test or training sets," "expert ground truth establishment," or an "MRMC comparative effectiveness study."

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them in the context of an AI/ML device. The document describes a traditional medical device submission.

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The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma. The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.

The provided text describes the COBE® Angel Whole Blood Separation System and its 510(k) submission, focusing on establishing substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way envisioned by the prompt's request for performance metrics (e.g., sensitivity, specificity, accuracy).

The document is a regulatory submission for a medical device that processes blood, not an AI/algorithm-based diagnostic device where typical AI acceptance criteria would apply. Therefore, many of the requested items (like ground truth, expert opinions, MRMC studies, AI assistance) are not relevant to this type of device and are not present in the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance:
   The document states: "A comparison of device features and in-vitro test data demonstrate that the Angel Whole Blood Separation System is substantially equivalent to the currently marketed Medtronic Magellan Autologous Platelet Separator System."
   However, specific quantitative acceptance criteria (e.g., minimum purity of plasma, recovery rate of platelets) and the exact reported performance values are not detailed in the provided text. The assessment for this type of device focuses on demonstrating "substantial equivalence" to a predicate device, which implies that its performance is comparable and safe/effective for its intended use, but doesn't typically involve the same kind of detailed performance metrics as a diagnostic algorithm.

2. Sample size used for the test set and the data provenance:
   The document mentions "in-vitro test data" but does not specify the sample size, the type of test set (e.g., number of blood samples), or data provenance.

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 as the device is a blood separation system, not an AI diagnostic system requiring expert-established ground truth for image or diagnostic interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and not provided.

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 as the device is a blood separation system, not an AI diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The concept of "ground truth" as typically used for AI diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For a blood separation system, "ground truth" would likely relate to objective measurements of the separated components (e.g., cell counts, protein concentrations) determined by laboratory techniques rather than expert consensus on diagnostic interpretation. The document does not detail these specific "ground truth" methods.

8. The sample size for the training set:
   The document does not mention a "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.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" through "comparison of device features and in-vitro test data" rather than providing a detailed breakdown of acceptance criteria and performance study results specific to AI/algorithm validation.

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The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.

The provided document describes a 510(k) premarket notification for a medical device, the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or establishing performance against specific acceptance criteria for a new clinical indication.

Therefore, many of the requested categories in your prompt are not applicable to this specific submission. The document explicitly states:

• "The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter. The devices are identical in design, method of operation, and fundamental scientific technology."
• "In-vitro tests were performed to demonstrate that the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter."

This indicates that the "study" was primarily in-vitro testing to confirm that the new device (with a surface coating) performed comparably to its predicate device, rather than a clinical study establishing new performance metrics against specific acceptance criteria for a novel application.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance thresholds. The acceptance criterion was "substantial equivalence" to the predicate device, demonstrated through in-vitro tests. These tests would have focused on verifying that the new surface coating did not negatively impact the filter's existing performance characteristics (e.g., filtration efficiency, blood flow compatibility, pressure drop).
• Reported Device Performance: The document states that the in-vitro tests demonstrated substantial equivalence. Specific quantitative performance data from these tests is not included in the provided text.

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

• Sample Size: Not specified in the provided document. The tests were "in-vitro," meaning they were conducted in a laboratory setting.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As an in-vitro study, this information is typically less relevant than for clinical trials.

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

• Not Applicable. This was an in-vitro performance test, not a study requiring expert interpretation of clinical data or images to establish ground truth.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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:

• No. This is not an AI-assisted device, nor is it a comparative effectiveness study involving human readers.

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

• Not Applicable. This is not an algorithmic device.

7. The type of ground truth used:

• For an in-vitro test demonstrating substantial equivalence, the "ground truth" would be established by the measured performance of the predicate device as a baseline, and the new device would be compared against that baseline in controlled laboratory conditions. The specific metrics (e.g., particle removal efficiency, pressure drop, blood compatibility markers) would constitute the ground truth for performance comparison.

8. The sample size for the training set:

• Not Applicable. This device does not have a "training set" as it's not a machine learning or AI-driven device.

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

• Not Applicable. See point 8.

In summary, the provided document is a 510(k) premarket notification for a minor modification to an existing device (adding a surface coating). The "study" was an in-vitro comparison to demonstrate that the modified device is substantially equivalent to the predicate device, not a performance study against novel clinical acceptance criteria. Therefore, most of the questions regarding clinical trials, expert ground truth, and AI-related metrics are not relevant to this specific submission.

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The COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

The COBE SMARxT VVR4000i Plus is a sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter. It is a sterile device with non-pyrogenic fluid pathways, for single use micgrar cardroionly micer. ilized by the user. Certain blood contact surfaces of the oxygenator only, and is not to be resterined by and dified to improve blood compatibility, resulting in reduced platelet adhesion on the treated surfaces.

The provided text describes a 510(k) notification for the COBE Cardiovascular SMARxT VVR4000i Plus Filtered Hardshell Venous Reservoir. This is a notification for a medical device that is substantially equivalent to a predicate device, not a new type of study proving the device meets acceptance criteria in the way a clinical trial would for a new drug or algorithm.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as this is a review of a Special 510(k) where the device is essentially an unmodified version with a surface-modifying material added. The "study" here refers to in-vitro tests demonstrating substantial equivalence, not a performance study against specific acceptance criteria for a new device's efficacy or accuracy.

Here's the breakdown based on the provided text, with N/A for information not present or not applicable to this type of submission:

Acceptance Criteria and Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: In-vitro tests. No information on country of origin. The study is laboratory-based (in-vitro), so retrospective/prospective does not apply in the typical clinical sense.

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

   • N/A. This was an in-vitro substantial equivalence study, not a study requiring expert-established ground truth in a clinical context.

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

   • N/A. This was an in-vitro substantial equivalence study.

4. 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:

   • N/A. This is a mechanical device, not an AI or imaging diagnostic device.

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

   • N/A. This is a mechanical device.

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

   • The "ground truth" for this substantial equivalence submission would be the performance characteristics and design parameters of the predicate device, against which the modified device was compared using in-vitro testing. The effect of the surface modification (reduced platelet adhesion) would be measured directly, not against an expert consensus or pathology.

7. The sample size for the training set:

   • N/A. This is a mechanical device, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established:

   • N/A. This is a mechanical device.

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The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.

The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack.

The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

The provided text is a 510(k) summary for a medical device (COBE Cardiovascular Revolution® Centrifugal Blood Pump with PC Coating) seeking substantial equivalence to a predicate device. It primarily focuses on regulatory approval based on material modification rather than a complex AI-based system. Therefore, many of the requested categories for AI-driven device studies, such as sample sizes for test/training sets, expert qualifications, and MRMC studies, are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate substantial equivalence for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a predicate device, particularly concerning performance characteristics and blood compatibility after the addition of a PC coating. The "performance" is assessed through in-vitro laboratory tests comparing the coated device to the uncoated predicate.

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

The document states "In-Vitro laboratory tests were performed." It does not specify the sample size of devices or the number of runs/experiments conducted. The data provenance is laboratory testing by COBE Cardiovascular, Inc. (manufacturer), presumably performed in the USA. Given this is a device performance test, it is by nature "prospective" for the devices being tested.

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. The "ground truth" for a physical device's performance in in-vitro tests typically comes from established experimental protocols and measurement standards rather than expert consensus on medical images or diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints where differing opinions need to be resolved.

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 is a physical medical device, not an AI-based diagnostic tool.

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

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For substantial equivalence of a physical device, the "ground truth" would be the established performance characteristics and safety profile of the predicate device (uncoated Revolution Centrifugal Blood Pump) as demonstrated through its original 510(k) submission (K011835) and relevant industry standards. The in-vitro tests for the new device would be compared against these benchmarks.

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

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

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

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The SMAR, T® BCD Vanguard™ Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways.

The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

The provided text describes a Special 510(k) Pre-Market Notification for the SMAR,T® BCD Vanguard™ Blood Cardioplegia System, which is a modified version of an existing device. The acceptance criteria and the study that proves the device meets these criteria are not explicitly detailed in the provided document.

However, based on the information given, we can infer some aspects of the "study" conducted and the implicit acceptance criteria:

Implicit Acceptance Criteria and Reported Device Performance

"Study" Information (Inferred/Not Provided)

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Sorin Biomedica BCD Vanguard™ Blood Cardioplegia System, K934847) rather than reporting a comprehensive clinical study. The only "study" mentioned is:

1. Sample Size used for the test set and the data provenance: Not specified. The document only mentions "In-Vitro tests." These tests were likely laboratory-based, comparing the new device's performance characteristics (e.g., blood compatibility, heat exchange efficiency with new surfaces, pressure relief, bubble trapping) against the predicate device's established performance or accepted standards. The data provenance would be from laboratory testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For in-vitro tests, the "ground truth" is typically defined by engineering specifications, regulatory standards, or predetermined performance benchmarks for the predicate device, rather than expert consensus on patient data.
3. Adjudication method: Not applicable/Not specified. This is more relevant for studies involving human interpretation or clinical endpoints.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is more common for diagnostic imaging AI systems or scenarios where human reader variability is a significant factor.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical device, not an algorithm.
6. The type of ground truth used: For the "In-Vitro tests," the ground truth would be based on objective measurements against established engineering specifications, performance standards, and comparison with the predicate device's known performance characteristics. The goal was to prove the modified device was "substantially equivalent."
7. The sample size for the training set: Not applicable. This is not an AI/machine learning algorithm, so there is no training set mentioned or implied.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Changes and Justification for Substantial Equivalence:

The core of the submission (K021830) is a modification to an existing device (BCD Vanguard™ Blood Cardioplegia System, K934847). The changes are:

• Addition of surface-modifying material (Mimesys) to the heat exchanger.
• Substitution of SMAR,T Surface Modified Tubing and Connectors for various tubing and connectors.
• Substitution of High Impact Polystyrene (HIPS) for PolyEthylene Terephthalate Glycol (PETG) as the packaging material.

The document states that "In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847)." This means the "study" was focused on proving that these modifications did not alter the fundamental safety or effectiveness of the device as compared to the previously cleared predicate device.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the "In-Vitro tests" successfully demonstrated that the new device met the implicit acceptance criteria for substantial equivalence to the predicate.

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The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stöckert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., greater than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.

The provided 510(k) summary (K011835) describes a medical device, the COBE® Revolution™ Centrifugal Blood Pump, and its claim of substantial equivalence to a predicate device, the Medtronic BP-80 BioPump® Centrifugal Blood Pump. However, it does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be presented for an AI/ML powered device.

Instead, the submission focuses on comparing the technical characteristics of the new device to the predicate device to demonstrate substantial equivalence, which is a different type of evaluation. The "in-vitro test data" mentioned merely supports the claim of substantial equivalence, not a detailed performance study against specific acceptance criteria for an AI algorithm.

Therefore, many of the requested sections (2-7, 9) cannot be answered from the provided text as they pertain to AI/ML device studies that are not present.

Here's an attempt to answer the questions based only on the provided text, highlighting what information is available and what is not:

Acceptance Criteria and Study Information (Based on K011835)

This 510(k) submission establishes the substantial equivalence of the COBE® Revolution™ Centrifugal Blood Pump to the Medtronic BP-80 BioPump® Centrifugal Blood Pump. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs comparably to the predicate device across critical functional and design parameters, rather than meeting specific performance thresholds for an AI algorithm.

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

The submission does not explicitly state "acceptance criteria" in the format of predefined thresholds for performance metrics. Instead, it compares the characteristics of the new device to the predicate. The "reported device performance" is essentially the listed characteristics of the COBE Revolution Pump. The underlying acceptance criterion for the 510(k) process is "substantial equivalence" to the predicate.

Note: The implicit acceptance criteria for substantial equivalence mean that the differences in these parameters should not raise new questions of safety or effectiveness.

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

The document mentions "In-vitro test data" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective. It is an in-vitro comparison, not a clinical study with patients.

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 information is not provided in the 510(k) summary. The "ground truth" for this type of device comparison would be established engineering and performance standards, not expert evaluation of AI output.

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

This information is not provided.

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

No such study was conducted or reported in this 510(k) submission, as it is not an AI/ML powered device.

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

Not applicable, as this is not an AI/ML powered device.

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

The "ground truth" in this context is the established performance characteristics of the predicate device and engineering standards for blood pumps. It is not dependent on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic or prognostic device would be.

8. The sample size for the training set

Not applicable, as this is not an AI/ML powered device and therefore has no "training set."

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

Not applicable, as there is no training set for this device.

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The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.

The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.

The provided text is a 510(k) summary for a medical device modification, specifically the COBE SMARxT Optimin Surface Modified Hollow Fiber Membrane Oxygenator. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study with acceptance criteria and performance metrics for a new device.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable in the context of this 510(k) summary.

Here's why and what information can be extracted:

Why the requested information is not applicable:

• Substantial Equivalence: The primary goal of a 510(k) submission, especially for a modification, is to show that the new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that it has the same intended use and fundamentally similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
• No New Acceptance Criteria: The device is not being evaluated against a new set of functional or clinical acceptance criteria as if it were a novel device. Instead, its performance is compared to the predicate's established performance to ensure no degradation or new risks.
• No De Novo Clinical Study: The "STUDY" described in this document is a series of "in-vitro tests" designed to show equivalency, not a large-scale clinical trial to establish new performance metrics or compare against human readers.

What information can be extracted/inferred from the document regarding the "study":

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Implied): That the COBE SMARxT Optimin's in-vitro performance (e.g., gas exchange, heat exchange, blood compatibility) must be comparable to or better than the predicate device (COBE Optimin Hollow Fiber Membrane Oxygenator, K991452) and meet the established safety and performance profile for such devices. The document explicitly states the modification "improves the blood compatibility of the device," implying this was a key parameter assessed.
   • Reported Device Performance: The document states: "In-vitro tests were performed to demonstrate that the COBE SMARXT Optimin Hollow Fiber Oxygenator described in this submission is substantially equivalent to the COBE Optimin Hollow Fiber Oxygenator (K991452)." It does not provide specific numerical performance results from these in-vitro tests in this summary, but rather a concluding statement of substantial equivalence.

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

   • Sample Size: Not specified in the summary document. In-vitro tests typically involve multiple units but the exact number isn't provided.
   • Data Provenance: The tests were "In-vitro tests" conducted by the manufacturer, COBE Cardiovascular, Inc. (location: Arvada, CO). These would be prospective laboratory tests.

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

   • Not Applicable. As this was an in-vitro engineering and performance comparison, expert review in the sense of clinical ground truth (e.g., radiologist consensus) is not relevant. The "ground truth" would be established by validated laboratory measurement techniques against predetermined, engineering specifications or performance ranges of the predicate device.

4. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical interpretation (e.g., image reading). For in-vitro performance testing, the results are objectively measured and compared to specifications or predicate performance.

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:

   • No. This device is a blood oxygenator, not an AI-powered diagnostic tool. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant.

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

   • Not Applicable. This is a hardware medical device with a surface modification, not an algorithm.

7. The type of ground truth used:

   • For the in-vitro tests, the "ground truth" would be objective laboratory measurements of various performance parameters (e.g., gas exchange efficiency, heat exchange capacity, thrombogenicity/blood compatibility metrics) taken from the device itself, compared to the established performance characteristics and specifications of the predicate device.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of an in-vitro comparison between two physical devices. The device is not based on a machine learning algorithm.

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

   • Not Applicable. (See point 8).

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The SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to 6 hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump, through the extension line and appropriate cannula.

The SMAR T BCD Vanguard is a cardioplegia heat exchanger with integral bubble trap, available with various tubing configurations connected to the heat exchanger. A surface modifying material has been added to the primary blood contact assembly, primarily to improve the blood compatibility of the device. The heat exchanger assembly, aside from the surface modifying material, is for single use only, and has nonpyrogenic fluid pathways.

The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardioplegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

The provided text describes the 510(k) pre-market notification for the SMAR,T® BCD Vanguard™ Blood Cardioplegia System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be extracted directly from this submission.

Here's an attempt to populate the table and answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria. Instead, it refers to "in-vitro testing" performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "substantially equivalent" to the predicate.

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

The document describes "in-vitro testing" and "biocompatibility testing." It does not specify sample sizes for these tests, nor does it provide details about "test sets" in the context of clinical data or data provenance (e.g., country of origin, retrospective/prospective). These appear to be laboratory-based engineering and material science tests.

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

Not applicable. The study described involved in-vitro and biocompatibility testing for a medical device's physical and biological properties, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. The study involved laboratory testing to demonstrate substantial equivalence, not a clinical study with image interpretation 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

Not applicable. This device is a cardioplegia system, not an AI/ML-driven diagnostic or assistive device for human readers.

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

Not applicable. This device is a medical instrument, not an algorithm.

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

For the in-vitro and biocompatibility tests, the "ground truth" would be established by the results of standardized laboratory measurements and accepted scientific and engineering principles for evaluating device performance and material compatibility. For example, blood trauma parameters would be measured directly from the test in vitro system.

8. The sample size for the training set

Not applicable. This device is an instrument, not an AI/ML system requiring a training set.

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

Not applicable. See #8.

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