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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 Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.

Medline Stopcock and Manifold

This document is an FDA 510(k) clearance letter for the "Medline Stopcock and Manifold." It primarily concerns the regulatory approval of a medical device and does not contain information about a clinical study with acceptance criteria and device performance data in the context of AI/ML or diagnostic performance.

Therefore, I cannot provide the requested information, which typically pertains to studies evaluating the diagnostic accuracy, sensitivity, specificity, or other performance metrics of a device, especially those involving AI/ML components.

The provided document details:

• Device Name: Medline Stopcock and Manifold
• Regulation Number and Name: 21 CFR 870.4290 (Cardiopulmonary Bypass Adaptor), 21 CFR 870.4270 (Stopcock, Manifold or Fitting)
• Regulatory Class: Class II
• Product Code: DTL
• Indications for Use: To serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
• 510(k) Number: K120069
• Date of Clearance: April 3, 2012

This is a traditional medical device clearance, not a submission involving the kind of performance evaluation typically described by your prompt's questions (e.g., test sets, ground truth, expert adjudication, MRMC studies, AI/ML performance, etc.).

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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 SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.

This 510(k) summary describes a medical device, the SAFE MAXI venous/cardiotomy reservoir, and its claim of substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving the device meets them through a dedicated study with defined metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this document.

However, based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating similar characteristics and comparable performance to predicate devices to establish substantial equivalence.

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

The document does not specify a distinct "test set" in the context of a clinical or performance study with a defined sample size. The evaluation appears to be based on:

• Biocompatibility: Likely laboratory testing, potentially on material samples or the predicate device.
• Blood Cell Damage Test: This was performed using a "same blood pool" setup, suggesting a comparative in vitro or ex vivo experiment. The number of samples or runs is not specified.
• Effectiveness Testing: "Evaluating its operational characteristics" suggests various engineering or bench tests.

Data Provenance: Not explicitly stated, but given the manufacturer (POLYSTAN A/S, Denmark), the testing would likely have taken place in a laboratory setting, possibly in Denmark or the US. The nature of these tests (e.g., in vitro, bench testing) means they are not "retrospective" or "prospective" in the clinical trial sense.

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

Not applicable. This type of device evaluation (substantial equivalence to predicates for a physical component) does not involve expert consensus on "ground truth" derived from clinical cases, as would be common for diagnostic algorithms or imaging devices.

4. Adjudication Method for the Test Set

Not applicable. As above, this isn't a study design that involves expert adjudication of findings.

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 passive medical component (blood reservoir) and does not involve AI or human "readers."

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

Not applicable. This device is a physical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices. The device's substantial equivalence is established by demonstrating (through laboratory/bench testing) that its performance and safety characteristics are comparable.

• Biocompatibility: Chemical and biological testing standards (e.g., ISO 10993).
• Blood Cell Damage: Measured parameters (e.g., free hemoglobin, platelet activation) in an in vitro setup.
• Effectiveness: Engineering performance metrics (e.g., flow rates, defoaming efficiency, filtration efficacy, volume capacity).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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