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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.

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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.

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The INSPIRA™ ART100 system is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting six hours or less.

The INSPIRA™ ART100 system is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The INSPIRA™ ART100 system consists of the following components: Controller Unit, Pump Drive Unit, Manual Pump Drive Unit, Blood Flow and Bubble Detection Sensor, Temperature Sensor, Cable adapters for Pressure Sensors, Cable adapters for Temperature Sensor, Oxygenator and Pump Drive Holders. The system is compatible with a Non-Roller Centrifygal Pump (Capiox iCP Centrifyqal Pump). The Inspira Pump Drives are magnetically coupled exclusively with the Capiox iCP Centrifugal Pump, designed and manufactured by Terumo Cardiovascular Systems Corporation, and can be supplied by Inspira. The INSPIRA™ ART100 system is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors, pressure sensors, supplied by hospital users or other manufacturers.

The provided text describes a 510(k) premarket notification for the INSPIRA™ ART100 device. While it details the device's technological characteristics, intended use, and comparison to a predicate device, it does not include specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) or a detailed study proving the device meets these criteria in the context of an AI/human-in-the-loop system.

The device, Inspira Art100, is a cardiopulmonary bypass pump speed control system. The testing performed is related to ensuring the device functions as intended and meets safety standards, rather than evaluating specific clinical performance metrics typical of AI/ML-driven diagnostic or prognostic devices.

Therefore, many of the requested details about acceptance criteria and performance studies for an AI device cannot be extracted from this document.

However, I can extract information regarding non-clinical tests performed to demonstrate safety and effectiveness for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All testing met predetermined acceptance criteria." However, the specific acceptance criteria and detailed reported performance values for each non-clinical test are not explicitly provided in a table format. The reported performance is implicitly that the device passed these tests.

2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are non-clinical, bench, and simulated use tests for a pump speed control device, not a diagnostic or prognostic AI system using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., disease presence) is not relevant for the type of device and testing described. Expert involvement would be in the design, testing, and validation of the device's engineering and safety aspects.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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: No, this type of study was not done. The device is a cardiopulmonary bypass pump speed control system, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone device testing (bench tests) for its functional and safety performance, but not in the context of an AI algorithm vs. human performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests described, "ground truth" refers to engineering specifications, performance standards (e.g., for pump speed, flow rate accuracy), and compliance with recognized industry standards (e.g., IEC, ISO, ASTM).

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set of data.

9. How the ground truth for the training set was established: Not applicable.

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Extracorporeal Membrane Oxygenation

The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

· Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients;

· ECMO-assisted cardiopulmonary resuscitation in adults.

Cardiopulmonary Bypass

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 document is a 510(k) premarket notification summary for the CardiacAssist, Inc. LifeSPARC System. This submission appears to be for a software update to an already cleared device, not for a new device requiring extensive clinical trials to prove its performance against specific acceptance criteria.

The document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as such a study would typically be conducted for a novel device or a significant change in intended use, which is not the case here.

Here's why the requested information is absent and what the document does indicate:

1. A table of acceptance criteria and the reported device performance: This is not present. The submission focuses on demonstrating "substantial equivalence" to previously cleared versions of the LifeSPARC System, specifically due to a software update. This means the performance is assumed to be equivalent to the predicate devices, rather than being re-evaluated against new, explicit acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The testing mentioned is "Software Verification and Validation testing (including Cybersecurity)," which typically does not involve human patient data or "test sets" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" established by clinical experts is relevant for diagnostic or AI-driven devices that interpret complex data (like medical images). This device is a mechanical pump system with a controller, and its "performance" is assessed through engineering and software validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.

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 not an AI diagnostic tool and does not involve "human readers" interpreting data with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software Verification and Validation testing." This type of testing evaluates the algorithm's performance in isolation (standalone), but it's in the context of a software update for a medical device's control system, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For software validation, the "ground truth" would be the expected functional behavior of the software as defined by its requirements and specifications.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance and testing:

• Device Change: The submission is for an update to the software version of a currently cleared device (LifeSPARC System). All other aspects of the device are identical to the predicate and reference devices.
• Testing Performed: "Software Verification and Validation testing (including Cybersecurity) was completed for the Subject device with the new software."
• Conclusion: "Testing described in this notification demonstrates that the Subject LifeSPARC System performance is substantially equivalent to the legally marketed Predicate LifeSPARC System (K211830) and Reference device (K232132)." The document explicitly states that "no concerns regarding safety and effectiveness result from the software changes."

In essence, this FDA 510(k) clearance is based on demonstrating that the software update does not change the safety or effectiveness of the device compared to its previously cleared versions, and therefore, it is "substantially equivalent." It is not a submission for a new device requiring extensive new clinical performance data against pre-defined acceptance criteria.

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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.

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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.

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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."

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The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

The provided text describes the Anivia SG1000 Pump Console, a device intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures (up to 6 hours). The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Medtronic Bio-console® 560 Extracorporeal Blood Pumping Console, K131964).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Anivia SG1000 Pump Console. Instead, it broadly states that "All testing met predetermined acceptance criteria." The performance characteristics are described in comparison to the predicate and reference devices in the "Technological Characteristics" table, implying that the acceptance criteria for these characteristics are met by being "Same as predicate" or by having differences that "do not raise different questions of safety and effectiveness."

Here's a breakdown of the performance characteristics provided, and where the device's performance aligns with or is considered equivalent to the predicate:

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance, as this device does not involve AI or machine learning that would typically use such a test set. The non-clinical tests involved "system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing." The sample size for these engineering and performance tests is not quantified (e.g., number of devices tested, number of test runs).

Data provenance is not applicable since no clinical data or patient data was used to assess the device's performance in this 510(k) submission. All tests mentioned are non-clinical, benchtop, or simulated use.

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

Not applicable. This device does not involve a "ground truth" derived from expert review or clinical annotations for an algorithm. The evaluation relies on engineering tests and compliance with recognized standards.

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

Not applicable, as there is no "test set" in the context of human-reviewed data where adjudication would be necessary.

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 cardiopulmonary bypass pump console, not an AI/ML-driven diagnostic or interpretative tool that would involve human readers or an MRMC study.

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

Not applicable. This device is electro-mechanical hardware with software controls, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of medical device (a pump console), "ground truth" is established through engineering specifications, validated test methods (e.g., measuring pump speed, flow rate, alarm accuracy), and compliance with international consensus standards. There is no biological or imaging "ground truth" involved.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The software embedded in the device undergoes traditional software verification and validation.

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

Not applicable, as there is no training set.

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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.

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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.

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