Search Results

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.

This document describes the 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors. This is a medical device, not an AI/ML powered device, so several aspects of your request (e.g., number of experts, adjudication method, MRMC study, ground truth for AI/ML models) are not applicable.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as one might find for an AI/ML device where metrics like sensitivity, specificity, or AUC are reported against specific thresholds.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device (K220842) through non-clinical performance testing. The reported performance is an affirmation that the device met these implicit criteria by performing comparably to the predicate.

The non-clinical performance tests conducted to demonstrate this are listed:

• Operating Parameters
• Dynamic Blood Damage
• Heat Generation
• Air Entrapment
• Mechanical Integrity
• Durability/Reliability

The conclusion is that "Performance data confirmed that the subject device is equivalent to the predicate device and any differences in the device do not raise new questions of safety or effectiveness." This statement is the reported device performance in the context of a 510(k) for this type of device – it met the standards for substantial equivalence. No specific numerical thresholds or results are provided in this summary, as is common for non-AI/ML 510(k) submissions unless a specific performance standard requires it to be explicitly stated in the summary.

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

The document states "In vitro performance tests have been performed to support claimed substantial equivalence."

• Sample Size: The document does not specify the exact sample sizes (e.g., number of pumps tested) for each of the non-clinical performance tests. This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.
• Data Provenance: The tests are described as "In vitro performance tests," implying laboratory-based testing. "Performance testing in accordance with the special controls of 21 CFR 870.4360 was performed with the subject device (CP20V-NG)." This is prospective testing performed on manufactured devices. The country of origin of the data is not specified, but the applicant company is located in Italy (Spectrum Medical S.r.l., Mirandola, Italy).

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

This question is not applicable. This is a physical medical device, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" for a device like this comes from standardized engineering and biocompatibility testing methods, not expert consensus on medical images or patient outcomes.

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

This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is measured against physical properties and engineering 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

This question is not applicable. This is not an AI-powered diagnostic or assistive device. No MRMC study was conducted.

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

This question is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is established through:

• Engineering Specifications and Standards: The device's performance is measured against established engineering parameters and standards (e.g., relating to flow, pressure, heat, mechanical durability, blood damage).
• Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials are safe for biological contact.
• Sterilization Standards (ISO 11135:2014): Verifying the sterility of the device.
• Packaging Standards (ISO 11607-1:2019): Ensuring the integrity of the packaging.
• Regulatory Special Controls (21 CFR 870.4360): Specific performance requirements for nonroller-type blood pumps.

The "ground truth" is not based on expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML diagnostic.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/ML device that uses a "training set." The device is designed, manufactured, and tested, not "trained."

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

This question is not applicable. There is no "training set" or corresponding "ground truth" establishment in the context of this device.

Ask a specific question about this device

The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.

The furnished document is a 510(k) clearance letter for a medical device which is a physical blood pump, not an AI/software as a medical device (SaMD). Therefore, the questions related to AI/SaMD testing methodologies (such as sample size for training/test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract the relevant information regarding the performance data and the conclusion of the substantial equivalence for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing was conducted according to the special controls of 21 CFR 870.4360 and confirmed the subject device is equivalent to the predicate. While specific numerical acceptance criteria and precise performance data are not explicitly detailed in this summary, the categories of tests performed indicate the areas where the device's performance was evaluated against established benchmarks (likely derived from the predicate device's performance or regulatory standards).

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

This information is not provided in a quantifiable manner (e.g., number of units tested).

• Sample Size: Not specified. The document states "Performance testing...was performed with the subject device (CP22V-NG)." This implies a sufficient number of devices were tested to draw conclusions, but the exact count is not given.
• Data Provenance: The tests were likely conducted by the manufacturer, Spectrum Medical S.r.l., as part of their 510(k) submission. The document lists the company's address in Mirandola, MO, Italy. It's a retrospective study from the perspective of the submission, as the tests were completed before the submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the device is a physical blood pump, not an AI/SaMD requiring human expert annotation for ground truth. The "ground truth" for this type of device would be established through engineering specifications, validated test methods, and performance against established physiological or mechanical standards as outlined in the special controls (21 CFR 870.4360).

4. Adjudication Method for the Test Set

Not applicable for a physical device. Performance is measured objectively through lab tests and engineering evaluation, not through subjective reviewer adjudication.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool designed to be used by human readers.

6. Standalone Performance

Yes, standalone performance testing was conducted. The non-clinical performance tests listed (Operating Parameters, Dynamic Blood Damage, Heat Generation, Air Entrapment, Mechanical Integrity, and Durability/Reliability) directly evaluate the device's inherent performance characteristics independently. The device's performance was then compared to that of the predicate device to establish substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Engineering Specifications: The device is designed to meet specific technical parameters (e.g., flow rate, pressure monitoring accuracy, heat generation limits).
• Regulatory Standards: Performance was measured against the special controls outlined in 21 CFR 870.4360, which define acceptable parameters for non-roller type blood pumps.
• Predicate Device Performance: The primary method for proving substantial equivalence was demonstrating that the subject device's performance was equivalent to that of its predicate device, which has a proven safety and effectiveness record.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/Machine Learning model that requires a training set.

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

Not applicable, for the reason stated above.

Ask a specific question about this device

The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

(i) Full of partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Devices are intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.

The device is non-toxic, non pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

This document is a 510(k) premarket notification for a medical device called the "Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors." The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a predicate device already on the market. In this case, the predicate device is the "Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors" (K201320), and a reference device is the "Quantum Perfusion Centrifugal Blood Pump CP37" (K202169).

The filing states that the new device, CP37 with Integrated Sensors, is essentially a variant introduced into the existing product family, aligning with the general structure, principle of operation, intended use, manufacturing, and sterilization processes of the previously cleared predicate and reference devices.

Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of crisp, quantitative acceptance criteria and corresponding reported device performance metrics in the format typically seen for a new algorithmic or diagnostic device. Instead, the approach taken is to demonstrate substantial equivalence to existing cleared devices (CP22 with Integrated Sensors and CP37).

The implicit "acceptance criteria" appear to be that the new device variant (CP37 with Integrated Sensors) performs equivalently to the predicate (CP22 with Integrated Sensors) and reference (CP37) devices for its intended use, without raising new issues of safety or effectiveness.

The reported device performance is conveyed through the statement:
"Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices. Applicable testing activities demonstrated that the proposed device model does not raise any issues of safety and effectiveness as compared to the currently cleared predicate and reference product."

Therefore, the "performance" is that it met the same standards as the cleared devices.

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

The document states:
"The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:

• ...
• Review and Assessment of data available on predicate( K201320) and reference (K202169) devices submission and applicability to new variant introduced in the product family portfolio."

This indicates that the "test set" for demonstrating safety and effectiveness was primarily based on a review and assessment of existing data from the previously cleared predicate (K201320) and reference (K202169) devices. There is no mention of a new, distinct "test set" with a specific sample size.

Data Provenance: The original data for the predicate and reference devices would have been generated during their respective premarket clearances. The current submission is a Special 510(k) for a device variant, often relying on existing data and non-clinical bench testing. The document does not specify the country of origin or whether the original data was retrospective or prospective beyond referring to previous submissions.

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

This information is not applicable/provided in the document. The submission is for a physical medical device (blood pump with sensors), not an AI/software diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance would be engineering specifications, physical measurements, and biocompatibility testing, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Since the "test set" primarily involved a review of existing data and non-clinical testing for a physical device, there isn't an "adjudication method" in the sense of reconciling differences in expert interpretations of data as would be found in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers, often with and without AI assistance, to measure the impact of AI on reader performance. This submission is for a physical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone study was not done in the context of an algorithm's performance without human intervention. This device is a physical centrifugal blood pump with integrated sensors, not an AI algorithm. Its performance is measured by its mechanical and biocompatibility characteristics, not by an algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used:

The "ground truth" for this device relates to its engineering specifications, functional performance (e.g., pumping efficiency, pressure monitoring accuracy), material properties, and biocompatibility. This is established through:

• Engineering specifications and design documents.
• Bench testing results measuring flow rates, pressure accuracy, material strength, etc.
• Biocompatibility testing (e.g., ISO 10993 standards).
• Sterilization validation data.
• Compliance with applicable standards (e.g., ISO 15223-1:2021 for labeling).

The document explicitly states: "Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices." This implies that the "ground truth" and verification methods align with the established standards and protocols used for similar devices.

8. The Sample Size for the Training Set:

This information is not applicable/provided. This device is a physical medical device, not an AI/machine learning model that undergoes "training." Therefore, there is no training set sample size to report.

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

This information is not applicable/provided. As the device is not an AI/machine learning model, there is no training set or corresponding ground truth establishment process in that context.

Ask a specific question about this device

The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided text describes a 510(k) premarket notification for the LifeSPARC System, which is a nonroller-type blood pump used for cardiopulmonary bypass. The submission is a software update to an already cleared device, and thus the focus is on testing related to software and electromagnetic compatibility.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics in a table format. It generally states that "Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software and Electromagnetic Compatibility." This implies the device met the necessary standards for these aspects.

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 does not provide details on the sample size used for the test set or the data provenance. It only mentions "test data is provided regarding Software and Electromagnetic Compatibility" implying a test set was used but without specifying its characteristics.

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 document. Software and electromagnetic compatibility testing typically rely on engineering specifications and compliance standards rather than expert medical consensus for ground truth.

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

This information is not provided in the document. Given the nature of the testing (software and EMC), an adjudication method in the medical context (like for image interpretation) would not be applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of the LifeSPARC System. This submission is for a software update to a mechanical blood pump, focusing on its safe and effective operation, not its diagnostic or interpretative capabilities.

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

The document implies that standalone testing was performed for the software and electromagnetic compatibility aspects of the device. The "Testing of the LifeSPARC Controller demonstrates that no concerns..." suggests the algorithm's performance was evaluated independently against predefined criteria.

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

For software testing, the ground truth would typically be the expected functional behavior and performance defined by engineering specifications and industry standards for medical device software. For Electromagnetic Compatibility, the ground truth is compliance with relevant EMC standards (e.g., IEC 60601-1-2).

8. The sample size for the training set

The document does not mention a "training set" because this is not an AI/ML-driven device in the context of learning from data. The software update is likely a deterministic program, not a model trained on a dataset.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable to the information provided. The ground truth for the device's functionality would be established through its design specifications and validated through testing.

Ask a specific question about this device

The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

The Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours.

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

This document describes the Qura S.r.l. Quantum Perfusion Centrifugal Blood Pump CP20 and CP20 with Integrated Sensors (K220842).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for each performance test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate and reference devices, implying that the acceptance criterion for each test was to perform comparably or within expected safety limits as per relevant standards and guidance.

Below is a table summarizing the reported device characteristics relevant to performance and the tests conducted. The "Acceptance Criteria" column will be inferred as "Compliance with applicable standards and demonstration of substantial equivalence to predicate/reference devices."

Ask a specific question about this device

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.

The pump is intended for use with Terumo® Advanced Perfusion System 1 / Sams™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Capiox iCP Centrifugal Pump with Xcoating". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance testing data, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a study proving a device meets acceptance criteria.

The document is primarily an administrative letter granting market clearance based on substantial equivalence, not a detailed report of the studies performed to demonstrate that equivalence. It refers to the "Indications for Use" but does not detail the technical performance or the studies that underpinned the clearance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

The provided text does not contain the information necessary to answer your questions.

Ask a specific question about this device

The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive of Spectrum Medical is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

The Quantum Perfusion Centrifygal Blood Pump CP22 with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and the 510(k) summary provided do not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, the document states that "All testing passed by meeting the established requirements set for the devices." and that the device "does not raise any new issues in terms of product's safety or effectiveness as compared to the currently cleared predicate device."

However, the document does list the types of performance tests conducted, which imply the areas for which acceptance criteria would have been established. Based on the provided information, a conceptual table can be created, though without specific numerical targets or results:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of devices, number of repeated tests) for each in-vitro performance test. It broadly states that "In-vitro testing was performed."
• Data Provenance: The tests were "In-vitro" (laboratory-based) and conducted by Qura S.r.l. in Italy, where the company is based. The nature of these tests suggests they are prospective, as they were specifically designed and executed to support the 510(k) submission.

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

This information is not applicable to the studies described. The performance data presented are from non-clinical (in-vitro) testing, not studies involving independent expert assessment of, for example, diagnostic images. The "ground truth" for these engineering and performance tests would be defined by established standards (e.g., ISO, EP/UPS, FDA guidance) and the physical or chemical properties measured.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical engineering and performance tests, not studies requiring expert adjudication of observations or diagnoses. The "adjudication" is essentially the comparison of measured results against pre-defined acceptance limits derived from standards and engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate device." This type of study is specifically for evaluating human reader performance, often with AI assistance, which is not relevant for this device.

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

This question is not applicable to the device described. The Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensors is a physical medical device (a centrifugal blood pump), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. Its "standalone performance" refers to its operational performance as a device pumping blood and monitoring pressure, which was evaluated through the in-vitro tests listed.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Established requirements/standards: Applicable special controls (21 CFR 870.4360), ISO standards (ISO 11135:2014, ISO 11607-1:2019, ISO 10993-1:2018), and European Pharmacopoeia/United States Pharmacopeia (EP/UPS) requirements.
• Engineering specifications and design parameters: The device performance was measured against its own design specifications and intended performance characteristics.
• Predicate device characteristics: Substantial equivalence was demonstrated by showing performance comparable to the predicate device, implying the predicate device's established performance serves as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The design and manufacturing process would involve training of personnel, but not a data training set for an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.

Ask a specific question about this device

The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.

This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.

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

The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.

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

Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.

4. Adjudication Method for the Test Set:

Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.

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

This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was based on:

• Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
• Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
• Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.

Ask a specific question about this device

The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

Here's a breakdown of the acceptance criteria and study information for the Quantum PureFlow Centrifugal Blood Pump CP22 and CP37, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is to document a change in labeling regarding the removal of a warning and a package symbol related to DEHP content. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that this labeling change does not negatively impact the safety or effectiveness, and that the device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the traditional sense for this submission. The "test set" here refers to the review of standards compliance and labeling changes. No new physical device testing with a specific sample size is detailed.
• Data Provenance: The referenced standards (ISO 10993-18, ISO 15223-1:2016) are international standards. The evaluation of DEHP compliance and labeling update would have been conducted by Qura S.r.l. internally, likely using existing device specifications and documentation. The data is retrospective in that it refers to the original device design and its compliance with updated labeling and material standards.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The activities performed were:
  • DEHP evaluation: This is typically performed by specialists in material science, biocompatibility, and regulatory affairs, often with expertise in ISO 10993 series standards.
  • Labeling and IFU update: This would involve quality assurance and regulatory affairs personnel with expertise in medical device labeling regulations (e.g., ISO 15223-1:2016) and FDA requirements. The contact person is Raffaella Tommasini, QA&RA Director.

4. Adjudication Method for the Test Set

• Not applicable. This submission is about a labeling update and demonstrating continued substantial equivalence based on no design changes. It does not involve a "test set" in the context of clinical or performance data requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a blood pump, not an AI/imaging diagnostic tool, so MRMC studies are not relevant.

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

• No, this is not applicable. This device is a physical medical device (blood pump), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is compliance with established international standards for biocompatibility (ISO 10993-18) and medical device symbols/information (ISO 15223-1:2016), as well as the device's original design specifications from K192850. The "truth" is that the device's fundamental design and performance characteristics have not changed, and the labeling updates align with current regulatory expectations.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Ask a specific question about this device

The Affinity CP centrifugal blood pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP centrifugal blood pump is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump is intended for use with pump speed controllers approved by Medtronic or may be used with the Stöckert and Sorin centrifygal pump systems or the Sams and Terumo centrifygal systems by attaching the Affinity CP adapter.

Not Found

This document, K201068, is an FDA 510(k) premarket notification for the Medtronic Affinity CP Centrifugal Blood Pump, including models with Balance Biosurface and Cortiva BioActive Surface. It does not contain information about acceptance criteria or a study proving the device meets the criteria in the context of an AI/ML medical device.

The information provided describes:

• The FDA's substantial equivalence determination for the pump.
• The general controls and additional regulations applicable to the device.
• The Indications for Use for the various models of the blood pump.

Therefore, I cannot provide details on the specific points requested (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, ground truth types, training set details) because this document does not pertain to the performance evaluation of an AI/ML-driven device. It is a clearance letter for a physical medical device (blood pump).

Ask a specific question about this device