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The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir(s) is (are) used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The reservoir may also be used for Post-Operative Chest Drainage Procedures.
The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours.
The CAPIOX® RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min when used with a 3 Liter Reservoir).
The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The modified and predicate Capiox® RX device oxygenator utilizes a porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A wound fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.
The modified and predicate Capiox® RX device have an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.
With respect to the filtration of blood, the modified and predicate Capiox® RX Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
The design of the modified and predicate Capiox® RX devices both utilize an integrated oxygenator/heat exchanger module that provides for temperature control of blood as it enters the oxygenation phase. Each of the devices also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The reservoirs each provide filtration of venous and cardiotomy blood as it enters the reservoir.

The document describes a 510(k) premarket notification for a medical device called the "Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir." This particular submission is a "Special 510(k)" due to modifications made to the hardshell reservoir and a change in the plasticizer used in certain PVC tubing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: This 510(k) submission is for modifications to an existing device (Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, previously cleared under K130333). Therefore, the "acceptance criteria" discussed are primarily focused on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not raise new issues of safety or effectiveness. Clinical studies involving patients were explicitly deemed not necessary for this particular submission.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that substantial equivalence is demonstrated with several in-vitro performance evaluations. While it doesn't present a table with specific pass/fail criteria and exact numerical results, it does list the types of performance evaluations conducted to ensure the modified device performs comparably to the predicate.

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

The document does not specify exact sample sizes for each in-vitro test. It only lists the types of tests conducted. Since these are in-vitro performance evaluations, the "data provenance" would refer to the testing conditions and the specific samples of the device (modified vs. predicate) used in the lab tests. There is no mention of country of origin for data as it's not a clinical study.

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

This information is not applicable as the document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the modified Capiox® RX device to the predicate Capiox® RX device." The testing described is in-vitro performance evaluation, not expert-adjudicated clinical or image-based ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is an oxygenator and reservoir system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.

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

This information is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the in-vitro performance evaluations would be:

• Engineering specifications and regulatory standards: The tests are designed to demonstrate that the device meets predefined engineering requirements and applicable regulatory standards for blood oxygenators and reservoirs.
• Performance of the predicate device: The modified device's performance is compared against the established performance of the previously cleared predicate device, aiming for substantial equivalence rather than an absolute ground truth in the sense of a disease diagnosis.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device requiring a training set.

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

This information is not applicable as this is not an AI/machine learning device.

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The Capiox® Advance Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

The device may be used for procedures lasting up to 6 hours.

The Capiox® Advance Hardshell Reservoir device and the predicate Capiox® RX Hardshell Reservoir device are both used as a blood storage devices during and after cardiopulmonary bypass procedures. Venous blood enters the reservoir via gravity, or by way of external vacuum that may be applied to the reservoir.

Venous blood that is drawn from the patient enters the device via the venous blood inlet port. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

The design of the Capiox® Advance Hardshell Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. It contains a rotatable venous blood inlet port. The total capacity of the reservoir is 4000mL.

The venous section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal.

The provided text describes a 510(k) premarket notification for the Capiox® Advance Hardshell Reservoir (K153143). This is an administrative document for a medical device and, as such, it does not contain the detailed data from clinical studies with acceptance criteria, sample sizes, or ground truth establishment that would be present in a research paper.

However, I can extract the relevant information that is available about the performance evaluations and what they aim to show for the device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Performance Evaluations" that were conducted to establish substantial equivalence to a predicate device (Capiox® RX Hardshell Reservoir; K130359). However, it does not provide specific numerical acceptance criteria or the reported device performance for each evaluation. It simply lists the types of tests performed.

The document states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence... Substantial equivalence is demonstrated with the following in-vitro performance evaluations." This indicates that the evaluations listed above are the studies that demonstrate the device meets the necessary criteria for substantial equivalence, implying their results were favorable and met internal company-defined specifications, even if those are not explicitly detailed here.

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

The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate device." Therefore, there was no test set with human patient data used for this 510(k) submission.

The provenance of the data for the in-vitro performance evaluations is not specified, but it would typically be internal laboratory testing conducted by Terumo Cardiovascular Systems Corporation.

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

Not applicable, as no clinical studies with human patient data were conducted that would require expert-established ground truth. The evaluations were in-vitro tests, likely with predefined physical or chemical standards.

4. Adjudication method for the test set

Not applicable, as no test set with human patient data was used.

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 hard-shell reservoir, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the in-vitro performance evaluations would be the established scientific and engineering standards and specifications for devices of this type, as well as the performance of the predicate device. For example:

• Air Handling Performance: Likely measured against predefined thresholds for air bubble removal efficiency.
• Hemolysis: Measured against acceptable levels of blood cell damage according to ISO standards or industry best practices.
• Venous Filter Dynamic Hold Up and/or Pressure Drop: Measured against specifications ensuring adequate blood flow and minimal retention.
• Product Integrity/Seal, Burst, Leak, Circulation, Pull Testing: Measured against engineering specifications for mechanical strength and leak resistance.
• Pre-Connect Evaluation: Likely assessed for ease of connection and secure fit.
• Package Testing: Assessed against standards for maintaining sterility and integrity during shipping and storage.

These "ground truths" are based on engineering principles, industry standards (e.g., ISO), and the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary:

The provided document describes a 510(k) premarket notification for a Class II medical device, the Capiox® Advance Hardshell Reservoir. The submission relies on demonstrating "substantial equivalence" to a predicate device through in-vitro performance evaluations rather than clinical studies with human patients. As such, information typically found in detailed studies evaluating diagnostic algorithms (like acceptance criteria, sample sizes for human readers/patients, ground truth establishment by experts, or AI-specific studies) is not present. The "studies" in this context are a series of laboratory-based engineering and performance tests designed to confirm that the modified device functions comparably and safely to its predicate.

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The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber;
• a temporary storage reservoir for priming solution and blood;
• the filtration of particulates from bank blood and filtration of blood recovered from the field by suction:
• the addition of medications or other fluids.

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for:

• the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

The Intersept™ Filtered Cardiotomy Reservoir is a single-use, device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2,600 ml. The maximum recommended flow rate is 2 liters per minute (LPM).

Each reservoir has eight luer or 1/4" (0.6 cm) ID access ports;

• four suction access ports .
• two pre-defoamer and two post-defoamer access ports. One of the post-defoamer access . ports is intended for use as a vent.

Each Intersept™ Filtered Cardiotomy Reservoir contains an open cell polyurethane defoamer with a 20 micron microaggregate filter covered with a polyester sleeve.

This document is a 510(k) premarket notification for the Intersept™ Filtered Cardiotomy Reservoir. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with reported performance metrics in the format requested.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth details for training and test sets) cannot be fully answered from the provided text. The document is primarily a regulatory submission for a medical device, which often uses comparison to a predicate as the basis for clearance, rather than presenting a novel clinical study with detailed performance metrics against pre-defined acceptance criteria.

However, based on the provided text, here is what can be inferred and explicitly stated:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device in terms of performance. The "Results" column only states "Pass," indicating that the device met the performance standards demonstrated by the predicate.

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

The document does not specify the sample sizes used for the "Filtration Efficiency," "Blood Trauma," or "Biocompatibility" tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. The document describes engineering and biological testing, not a study involving ground truth established by medical experts for diagnostic interpretation.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

For the tests mentioned:

• Filtration Efficiency: The ground truth would likely be established through standard laboratory methods for measuring particle retention (e.g., gravimetric analysis or particle counting) against a known challenge.
• Blood Trauma: Ground truth would be established through laboratory analysis of blood samples (e.g., measurement of hemolysis, platelet activation, or other markers of blood damage) directly comparing the device's impact to that of the predicate or established benchmarks.
• Biocompatibility: Ground truth is established through standardized in-vitro and/or in-vivo testing according to ISO 10993 series for medical devices.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning model, so there is no training set.

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

Not applicable. There is no training set.

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The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterile and non-pryogenic.

The provided document describes a 510(k) premarket notification for a medical device modification, specifically for Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The provided information details design verification tests, which are engineering-focused assessments, not clinical performance studies with acceptance criteria as typically understood in the context of AI/ML performance metrics (e.g., sensitivity, specificity).

Here's why the requested information cannot be fully provided from this document:

• Device Type: The device is a "Venous Hardshell Cardiotomy Reservoir," which is a physical medical device used in cardiopulmonary bypass operations, not an AI/ML algorithm.
• Study Type: The submission is a 510(k) for a "device modification," which relies on demonstrating substantial equivalence through non-clinical (i.e., laboratory/benchtop) design verification tests rather than clinical studies.
• Focus: The focus of the 510(k) is on the safety and performance of the modified physical components (defoamer coating, flow rates, volumes), not on the diagnostic or predictive accuracy of an algorithm.

However, I can extract the relevant information regarding the design verification tests performed, which serve a similar function to "proving the device meets acceptance criteria" within the context of hardware modifications:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each test, nor does it provide a detailed "reported device performance" table with precise quantitative results. Instead, it indicates that the tests were performed to show the modified device is "as safe and effective as the originally cleared devices" and that the "evaluation and test results do not show any kind of risk potential."

Regarding the specific questions tailored for AI/ML device studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. The "tests" were design verification tests (benchtop/laboratory), not clinical studies with 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 for a physical device's performance often comes from engineering specifications, established testing protocols, and physical measurements, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set: Not applicable. There is no mention of expert review or adjudication in the context of these engineering design verification tests.

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 is a physical device, not an AI/ML algorithm used for image interpretation or diagnosis by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the design verification tests listed, the "ground truth" would be established by predefined engineering specifications, performance standards, biological safety standards (e.g., ISO standards for biocompatibility), and comparison to the predicate device's known performance characteristics.

8. The sample size for the training set: Not applicable. This device does not involve machine learning and therefore has no training set.

9. How the ground truth for the training set was established: Not applicable. This device does not involve machine learning and therefore has no training set.

In conclusion: The provided document is for a traditional medical device modification (physical product) and uses design verification testing to demonstrate substantial equivalence, not a clinical study to establish performance metrics for an AI/ML device. Therefore, many of the requested fields are not applicable to this submission type.

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The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.

The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in jan extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during toutine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.

The Affinity Pixie Cardiotomy Venous Reservoir is coated with either Carmeda BioActive Surface or Balance Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Medtronic Affinity Pixie Cardiotomy Venous Reservoir:

This document is a 510(k) summary for a medical device (K141233), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within this regulatory context.

The device in question is the Medtronic Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda® BioActive Surface or with Balance® Biosurface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are generally framed as demonstrating equivalence to the predicate device in terms of design, materials, principles of operation, and performance. The "reported device performance" is the result of bench testing confirming these aspects.

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

The document explicitly states that "Bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence."

• Test Set Sample Size: Not specified in the provided document. For bench testing, typical sample sizes vary depending on the specific test and statistical requirements, but no numbers are given here.
• Data Provenance: The data is from bench testing conducted by Medtronic, Inc. This is not human clinical data; it's laboratory/engineering data. It is prospective in the sense that the tests were conducted specifically for this 510(k) submission. No country of origin for the data (beyond the applicant being US-based) is specified, but it would have been generated in a controlled, manufacturing/testing facility.

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

Not applicable. Since clinical studies (which would typically involve expert reviewers to establish ground truth) were not required and not performed, there were no "experts" in this context establishing ground truth for a clinical test set. The "ground truth" for bench tests is based on engineering specifications, regulatory standards, and comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like '2+1' or '3+1' are used for interpreting clinical data, particularly image-based studies, often involving multiple readers. Given that this submission relies on bench testing and not clinical trials, no such adjudication method was employed.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study involves multiple human readers evaluating cases, often with and without AI assistance, to assess the impact of the AI on reader performance. This type of study is specifically for evaluating the effectiveness of AI algorithms in a clinical setting. As this device is a physical medical device (Cardiotomy Venous Reservoir) and not an AI/software as a medical device (SaMD), and no clinical studies were performed, an MRMC study was not applicable and was not conducted.

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

No. This question is also specifically relevant for AI/SaMD devices. Since the device is a physical reservoir for cardiopulmonary bypass and not an AI algorithm, a "standalone algorithm performance" study is not applicable and was not performed. The performance evaluated was of the physical device itself in bench tests.

7. The Type of Ground Truth Used

The type of "ground truth" used for this 510(k) submission is primarily based on:

• Engineering specifications and design requirements: For parameters like cap removal force, particulate generation, and biocompatibility.
• Regulatory standards: Ensuring compliance with relevant industry and FDA standards for blood-contacting devices.
• Predicate device performance: The critical "ground truth" for a 510(k) is the established, safe, and effective performance of the legally marketed predicate device (K100645). The new device's performance in bench tests must demonstrate it is "the same" or does not raise new questions of safety or effectiveness compared to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The concept of a training set is specific to machine learning.

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

Not applicable. As there is no AI/ML component, there is no training set and thus no ground truth established for it.

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Oxygenator: The Affinity Pixie Hollow Fiber Oxygenator with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Cardiotomy Venous Reservoir: The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

Temperature Probe: The Affinity Temperature Probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's Instructions for Use. The Temperature Probe is designed for use with a YSI™ Telethermometer to monitor and display temperature.

The Affinity Pixie Oxygenation System with Carmeda BioActive Surface or Balance Biosurface is a system that includes an oxygenator, cardiotomy/venous reservoir (CVR), and temperature probe.

The oxygenator is a single use, sterile, nonpyrogenic fluid path oxygenator to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during cardiopulmonary bypass procedure up to 6 hours in duration.

The reservoir is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.

The temperature probe is a reusable device for use with the temperature monitoring adapter of compatible Medtronic devices and the YSI™ Telethermometer. The probe has a thermistor sensor housed in a stainless steel sheath connected to a 3 m (10 ft) shielded cable, terminating with a 7 mm (1/4 in) phono plug.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific "acceptance criteria" for performance in a table format with numerical targets. Instead, it states that "Comparisons of the performance of the Affinity Pixie Oxygenator and the predicate devices were conducted. The comparisons demonstrated that there were no significant performance differences between the devices." This implies that the acceptance criteria for the Affinity Pixie system were to demonstrate performance substantially equivalent to its predicate devices in various aspects.

Therefore, the table below will reflect this substantial equivalence approach for each component:

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

The document does not specify a numerical sample size for the test set. It mentions "Bench and animal testing" were used for performance characteristics.

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: The document implies the testing was conducted in a laboratory or preclinical setting ("Bench and animal testing"). No specific country of origin is mentioned, but as Medtronic is a US-based company, it's reasonable to assume the testing occurred domestically or at affiliated facilities. The testing was conducted for regulatory submission, making it prospective in nature for this specific evaluation, even if some animal models might reuse data from previous studies.

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

This information is not provided in the document. The testing involved "Bench and animal testing," which likely relies on established measurement techniques and scientific principles rather than human expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable in the context of bench and animal testing. The objective measurements from these tests would not typically require an adjudication method among experts.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical performance testing, not on assessing human reader improvement with or without AI assistance.

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

Yes, the testing described appears to be a standalone (algorithm/device only) performance evaluation. "Bench and animal testing" inherently exclude direct human-in-the-loop performance assessment in the context of a medical device's technical specifications.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluations (bench and animal testing) would have been established through:

• Objective measurement standards: For parameters like oxygenation, CO2 removal, blood flow, temperature accuracy, and filtration efficiency, the "ground truth" is typically determined by established scientific measurement techniques and calibrated equipment.
• Physiological measurements: In animal testing, ground truth would be based on physiological responses and measurements within the animal models.

8. The Sample Size for the Training Set:

The document does not describe any "training set." This type of testing (bench and animal for substantial equivalence) does not typically involve a machine learning model that requires a training set.

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

Not applicable, as no training set is mentioned or implied for this device's evaluation.

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The Venous Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

The Venous Hardshell Cardiotomy Reservoir is a reservoir with integrated filters and a defoamer. It is designed to be open or vacuum-tight. It may be marketed both as single product and as pre-assembled combination with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAQUET Venous Hardshell Cardiotomy Reservoirs with Softline Coating:

It's important to note that the provided documents (a 510(k) Summary and an FDA determination letter) describe a substantial equivalence determination for a medical device. This type of submission typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing a clinical investigational study to prove de novo efficacy or safety against a set of clinical acceptance criteria. Therefore, the "acceptance criteria" and "study" described below are primarily focused on the engineering and performance characteristics of the device and its coating, not on its clinical performance compared to a baseline or an alternative treatment in a human population.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices. The study performed focuses on verifying that the new device, despite a change in coating, performs identically or acceptably compared to the predicate regarding crucial safety and performance aspects.

Study Information Table

Given the nature of a 510(k) submission focused on substantial equivalence with a minor change (coating), the "study" is primarily a series of engineering and biological tests rather than a large-scale clinical trial.

Summary of the "Study" and its Rationale:

The study conducted was a series of evaluations and tests focused on four main areas:

1. Integrity: To ensure the structural soundness and leak-proof nature of the reservoir.
2. Performance: To verify that the reservoir performs its intended functions (collecting, storing, filtering blood) as effectively as the predicate devices.
3. Biocompatibility: To confirm that the materials, especially the new Softline Coating, are safe for contact with human blood, referencing the fact that the same coating is already used in another cleared device (K082117).
4. Sterility: To ensure the device can be and is sterilized to appropriate medical device standards.

The primary goal of these evaluations was to demonstrate substantial equivalence to the predicate devices. Since the only change from the predicate "Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating" was the replacement of "Safeline Coating" with "Softline Coating," the study heavily leveraged the prior clearance of the "QUADROX-i Adult microporous membrane Oxygenator with ... Softline Coating (K082117)." This means the biocompatibility and performance of the Softline coating itself were likely already established and understood from the K082117 submission, simplifying the current submission by demonstrating that the system (reservoir + Softline coating) functions comparably to the predicate system (reservoir + Safeline coating) and that the Softline coating behaves as expected in this new device.

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The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.

The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.

The provided text is a 510(k) summary for the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir, a medical device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this submission.

The document describes a traditional medical device and its predicate comparison, focusing on safety, performance, and validation for its intended use.

Here's the information that can be extracted relevant to the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it broadly states that "the device meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."

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

The document states, "The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests..."

However, specific sample sizes for testing (e.g., number of units tested, number of in-vitro or in-vivo trials) are NOT provided. The text does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, which are typical considerations for clinical trials, not necessarily for engineering performance validation of a mechanical device like this.

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

This section is not applicable as the ground truth concept (e.g., for diagnostic accuracy) is not relevant to the performance validation of a mechanical device like a blood reservoir. The device's performance is assessed against engineering specifications, not clinical interpretations by experts.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication is typically used to resolve discrepancies in expert interpretations or assessments, which is not relevant for the functional and safety testing of this mechanical device.

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 is not applicable. The device is a hardshell venous reservoir, a mechanical component of a cardiopulmonary bypass circuit. It is not an AI-driven diagnostic or assistive technology, and therefore, human reader improvement or MRMC studies are entirely irrelevant.

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

This is not applicable. The device is a mechanical blood reservoir, not an algorithm.

7. The type of ground truth used

For a mechanical device like this, the "ground truth" is typically defined by engineering specifications, design requirements, and applicable industry or regulatory standards. Performance tests verify if the device meets these pre-defined physical and functional parameters (e.g., flow rates, filtration efficiency, defoaming capability, material compatibility, sterile barrier integrity). There is no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy for this type of device's core validation.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

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The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.

The MEDOS HILITE MVC 4030 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 4030 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/2' venous inlet at the center top section of the lid. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 7 lpm. The maximum cardiotomy flow rate is 4 lpm.

The provided text describes a medical device submission (K083131) for the Medos Hilite MVC 4030 Hardshell Venous Reservoir. This is a conventional 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of AI/software devices. The submission focuses on device characteristics, intended use, and performance tests related to its manufacturing quality and functional requirements.

Therefore, many of the requested points, especially those related to AI/algorithm performance (e.g., sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this type of traditional medical device submission.

Here's the information that can be extracted and inferred from the provided text, addressing the applicable points:

1. Acceptance Criteria and Reported Device Performance

The submission states that the device was "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" and "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

While specific quantitative acceptance criteria are not detailed in the summary, the general areas of performance and safety are highlighted. The reported "performance" is that the device meets these functional requirements and specifications.

• Collection, storage, and filtration of blood during cardiopulmonary bypass.
• Filtering and defoaming intrathoracic suctioned blood.
• Operation at venous flow rates of 1.0 to 7.0 liters per minute.
• Operation at cardiotomy flow rates of up to 4.0 liters per minute.
• Use for periods up to 6.0 hours. |
  | Safety Standards Compliance | The device complies with applicable industry and safety standards. Implicitly, this includes being sterile, non-pyrogenic, and single-use, as stated in the description. |
  | Equivalence to Predicate | The device is considered equivalent in safety and effectiveness to the predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) based on being able to perform the same indications for use and having similar technological characteristics. The FDA's substantial equivalence determination implies it meets sufficient standards comparable to the predicate. |

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

This is not applicable as this is not a study evaluating an algorithm on a "test set" of data in the AI sense. Performance testing would have involved physical units of the device. The text does not provide details on the number of physical units tested.

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

This is not applicable. Ground truth in this context refers to established functional parameters and safety standards for the device's physical operation. It does not involve expert review or consensus of interpretable data like medical images.

4. Adjudication method for the test set

This is not applicable. Regular engineering testing and validation procedures would have been followed, not adjudication in the context of expert review.

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 is not applicable. This device is a hardware component for cardiopulmonary bypass and does not involve AI or human-in-the-loop performance for image reading or diagnosis.

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

This is not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance would be derived from:

• Engineering specifications and design requirements: These define what the device should do (e.g., flow rates, filtration efficiency).
• Established industry standards: Pertaining to biocompatibility, sterilization, materials, and mechanical integrity for blood-contacting devices.
• Comparability to the predicate device: The predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) serves as a benchmark for performance and safety.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

This is not applicable. No training set exists for this type of device.

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The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defoamer sponge and 20 micron depth filter. The maximum venous flow rate is 8 lpm. The maximum cardiotomy flow rate is 4 lpm.

This document describes a 510(k) submission for the Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating, a medical device used during cardiopulmonary bypass surgery. It is a traditional 510(k) submission, indicating that the device demonstrates substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding performance metrics. Instead, it relies on the concept of "functional requirements and performance specifications" and "applicable industry and safety standards," along with comparison to predicate devices, to establish safety and effectiveness.

However, based on the description, we can infer some performance aspects:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "extensive safety, performance, and validations" were conducted.

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

This type of information is not applicable to this device. This is a medical device (a blood reservoir), not a diagnostic or AI-powered device that requires expert interpretation to establish ground truth for a test set. The validation would have involved engineering tests, material compatibility tests, and performance demonstrations against specifications.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive component requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical blood reservoir, and an MRMC study related to AI assistance for human readers is not relevant to its evaluation.

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

This information is not applicable. The device does not involve an algorithm or AI component.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for this device would be established by:

• Engineering specifications and test methods: Verifying that the device meets defined physical dimensions, material properties, flow rates, filtration efficiency, and other operational parameters.
• Biocompatibility testing: Demonstrating that the materials are safe for contact with blood, often using established standards and lab tests.
• Sterility and pyrogenicity testing: Ensuring the device is sterile and non-pyrogenic according to recognized standards.
• Comparison to predicate devices: Demonstrating that the new device performs equivalently or better than previously cleared devices for its intended use.

8. The sample size for the training set

This information is not applicable. The device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable. The device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.

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