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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 Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.

Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".

The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.

To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.

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The Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.

Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.

The provided document is a 510(k) summary for a medical device called the "Quantum Perfusion Dual Lumen Cannula 31F-V1." It does not describe an AI/ML powered device, therefore the requested information regarding acceptance criteria, study details, and human-AI interaction is not applicable. The document focuses on regulatory approval for an updated version of an existing medical cannula.

Here's a breakdown of why this information isn't available in the document:

• Device Type: The device is a physical medical cannula used in cardiopulmonary bypass, not an AI/ML software or algorithm.
• Approval Type: The document is a 510(k) premarket notification, which is for demonstrating substantial equivalence to a legally marketed predicate device, not for a novel AI/ML application that would require extensive performance studies as requested.
• Performance Data: The "Performance Data" section explicitly states "NON-CLINICAL TESTING" and lists updates to labeling and performance tests according to recognized consensus standards for the physical device. It also states "No animal studies have been performed" and "No clinical data have been included."

Therefore, I cannot provide the requested information for acceptance criteria and study proving device meets said criteria as it pertains to AI/ML devices.

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