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The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

RAP Femoral venous cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The device is composed of a cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the femoral vein till the vena cava. The cannula and the obturator are packaged within the same pouch and sold together.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" to ½" barbed connector for standard cardiopulmonary bypass tubing.

The RAP femoral arterial cannulae are the modified version of the disposables currently marketed as the RAP Femoral Venous cannula (K052081).

This document, an FDA 510(k) Clearance Letter, is for a medical device (a cannula) and not for a software or AI-based medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria for an AI/software device.

The questions in your prompt are highly specific to AI/Machine Learning device validation, such as:

1. Acceptance criteria for AI performance: (e.g., sensitivity, specificity, AUC)
2. Sample size, provenance, expert ground truth, adjudication: These are standard for evaluating AI model performance.
3. MRMC study and effect size: How AI assists human readers.
4. Standalone performance: Algorithm without human input.
5. Type of ground truth: Pathology, outcomes, expert consensus.
6. Training set details: Sample size and ground truth establishment.

None of this information is relevant or present in the provided 510(k) clearance letter for the RAP Femoral Arterial Cannulae, which is a physical device subject to mechanical, material, and biocompatibility testing.

The document confirms the device meets acceptance criteria through:

• Non-Clinical Performance Data: Extensive verification and validation testing of the physical device components and function (e.g., visual inspection, connector testing, flow rate, kink test, pull strength, blood trauma characterization, biocompatibility tests).
• No Clinical Performance Data: The submission explicitly states "No clinical testing was conducted in support of the RAP Femoral venous cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

Therefore, I cannot extract the information asked in your prompt from this particular document.

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The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours.

The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.

Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" barbed connector for standard cardiopulmonary bypass tubing

In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line.

The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula.

The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours

The provided FDA 510(k) Clearance Letter for the Easyflow Cannulae does not contain any information related to a study proving the device meets acceptance criteria for an AI/ML (Artificial Intelligence/Machine Learning) powered medical device.

This document describes a medical device (cannulae for cardiopulmonary bypass) which is a physical, single-use, non-toxic, non-pyrogenic fluid path device. The clearance is based on "substantial equivalence" to predicate devices, meaning it has similar indications for use and technological characteristics, with the primary change being the removal of phthalates (DEHP and DnHP) from the PVC materials.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device, as this information is not present in the provided text.

The information you asked for, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are all highly specific to the validation of AI/ML algorithms, which are not relevant to the Easyflow Cannulae as described in this FDA clearance.

In summary, based on the provided document, there is no AI/ML component to the Easyflow Cannulae, and thus no such study or acceptance criteria as you've outlined would be applicable or present.

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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

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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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The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours.

The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations.

The device is available in two styles: with a vent line (R502) and without a vent line (R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device. This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:

The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K200612).

The provided text is a 510(k) premarket notification summary for a medical device, the R501-R502 aortic root cannulae. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets a specific set of acceptance criteria through a clinical study or a multi-reader, multi-case (MRMC) study.

Therefore, many of the requested details, such as acceptance criteria, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of regulatory submission. The primary method of demonstrating safety and effectiveness in this document is comparison to a predicate device via non-clinical performance data and a statement of substantial equivalence.

Here's an explanation based on the provided text:

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

This document does not contain a table of explicit acceptance criteria with corresponding device performance results in the way one would expect from a clinical trial or a formal validation study for a novel device. Instead, the performance is demonstrated through a comparison to a predicate device and adherence to applicable voluntary standards.

The non-clinical performance data section states: "The device passed all the testing in accordance with national and international standards." This implies that the acceptance criteria for these tests were meeting the requirements of the standards, but the specific numerical criteria and results are not detailed.

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

• Test Set Sample Size: Not applicable. The submission relies on non-clinical performance data (testing) and a comparison to a predicate device. There is no "test set" in the context of clinical data or AI model evaluation.
• Data Provenance: Not applicable. As there are no clinical studies or AI evaluations described, there is no "data provenance" in terms of subject demographics or study design. The non-clinical testing was conducted by Sorin Group Italia s.r.l.

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

Not applicable. No ground truth was established by experts for a test set in the context of this submission, as it focuses on substantial equivalence through non-clinical testing and comparison to a predicate.

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

Not applicable. No test set requiring expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. This is explicitly stated in the document under "Clinical Performance Data": "No clinical testing was conducted in support of the R501-R502 Cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use."

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 (cannula), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

7. The type of ground truth used:

Not applicable. As no clinical studies or AI performance evaluations are described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) does not apply here. The submission relies on the established safety and efficacy of the predicate device and the results of non-clinical engineering and materials testing.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI models.

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

Not applicable. There is no training set for this device.

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EZ Glide Aortic Perfusion Cannulae:
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures.
Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

OptiSite Arterial Perfusion Cannulae:
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for

EZ Glide Aortic Perfusion Cannulae: The EZ Glide Aortic Perfusion Cannulae device deliver oxygenated blood from the cardiopulmonary bypass pump directly into the aorta. The cannulae terminate in a 3/8" (9.5mm) barbed tubing connector and a vent plug. Cannulae are wire-reinforced and include a dispersion tip in either a straight or curved configuration. EZ Glide Aortic Cannulae are available in sizes 21 French (Fr) and 24 French (Fr). The EZ Glide Aortic Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Note that there are no accessories packaged with the EZ Glide Aortic Perfusion Cannulae.

OptiSite Arterial Perfusion Cannulae: The OptiSite Arterial Perfusion Cannulae device is indicated for arterial perfusion in the extracorporeal circuit for less than 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. The Edwards Lifesciences Arterial Perfusion Cannulae have smoothly rounded tips to facilitate atraumatic insertion. The proximal ends of the cannula are designed to accept 3/8" (9.5mm) tubing. Introducers are provided with some arterial cannula codes. Introducers are designed for use with 0.038" (0.96 mm) quidewires. Each introducer is provided with a removable vented luer cap. Leave the vented cap in place to allow venting of the cannula for use without a guidewire. Remove the cap to allow cannula use with a guidewire. The OptiSite Arterial Perfusion Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

EndoReturn Arterial Cannulae: The EndoReturn Arterial Cannulae devices are flexible plastic tubes intended to provide a means of perfusing arterial blood returning to the patient from the oxygenator through the extracorporeal circuit during cardiopulmonary bypass procedures. The cannulae are placed either through the femoral artery or directly into the aorta to return oxygenated blood from the CPB circuit and to hemostatically introduce Edwards intra-aortic occlusion catheters. Each device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended and labeled for single use only. The Endo Return Arterial Cannulae with the hemostasis valve are made with a wirereinforced cannula shaft which provides kink resistance and flexibility, and include the following kit components: Introducer, Guidewire (0.038" (0.097mm) x 100 cm) J-tip, Connector hub. The tapered atraumatic tip aids in insertion and advancement into the femoral artery. The non-wire-reinforced clamp site(s), a 3/8 in. barbed connector, and a hemostasis valve allows passage of catheters such as the Edwards IntraClude intra-aortic occlusion device. The introducers accept a 0.038 in. (0.97 mm) quidewire and are marked to simplify assembly. A connector hub secures and immobilizes the introducer within the cannula for easier, oneperson insertion of the cannula/introducer assembly. A lubricious coating, (SlipCoat™) is applied to the surface of the EndoReturn arterial cannula shafts. This coating is intended to provide a lubricious surface effective for the duration of the intended use of the cannula, thereby easing the insertion of the cannula into the artery, and the aortic occlusion catheters through the cannula. The EndoReturn Arterial Cannulae are packaged sterile and nonpyrogenic in a sealed, peel-type pouch.

The provided document is a 510(k) summary for several arterial perfusion cannulae devices (EZ Glide, OptiSite, and EndoReturn). It states that no non-clinical and/or clinical tests were carried out in support of this special 510(k) premarket notification.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because such studies were not conducted for this specific submission as stated in the document.

The document indicates that the devices are considered substantially equivalent to previously cleared predicate devices, and the changes are primarily related to label updates (new warning statements) and the removal of references to a specific coating (Duraflo) that is no longer manufactured.

Given this, the following points would be the answer based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. No new performance data was generated or reported for this 510(k) submission as no tests were carried out.

2. Sample size used for the test set and the data provenance: Not applicable. No test set was used as no new studies were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used and no new ground truth was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set 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 not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new ground truth was established for this submission.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML algorithm.

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The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

The provided text describes a 510(k) premarket notification for a medical device, the DLP Silicone Coronary Artery Ostial Cannulae. It discusses a material formulation change to an adhesive used in the device and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the request asks for information related to a study proving device meets acceptance criteria for an AI/machine learning device, including aspects like:

• Acceptance criteria table and reported performance
• Sample size and data provenance for test sets
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC studies for human reader improvement
• Standalone algorithm performance
• Type of ground truth
• Training set sample size and ground truth establishment

The provided FDA document is for a physical medical device (cannulae) and focuses on demonstrating substantial equivalence due to a material change, not on the performance evaluation of an AI or machine learning algorithm. Therefore, the document does not contain any of the information requested regarding acceptance criteria, study design, expert involvement, or AI performance metrics.

In summary, none of the specific information requested in the prompt can be extracted from the provided text because the text describes a physical medical device submission, not an AI/machine learning device submission.

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These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Medtronic DLP™ Silicone Coronary Artery Ostial Cannulae. It details the substantial equivalence review process for a change made to the device's packaging material, specifically from a Surlyn film pouch to a Nylon film pouch.

Based on the document, this is not a study demonstrating the performance of an AI/ML powered device. Instead, it's a submission for a packaging material change for a physical medical device. Therefore, many of the requested criteria related to AI/ML device performance, ground truth, expert adjudication, and MRMC studies are not applicable to this document.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this specific packaging change.

Here's the breakdown:

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

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

The document does not explicitly state the sample sizes used for the functional testing, biocompatibility assessment, or shelf-life study. It also does not specify the provenance of this data (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, not usually summarized in this high-level 510(k) summary.

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

This is not applicable as this is a medical device packaging change, not an AI/ML performance study. The "ground truth" here would be the physical and biological properties meeting specifications, evaluated by standard engineering and laboratory methods, not expert human interpretation of data like medical images.

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

Not applicable. This concept applies to human interpretation of data, typically in AI/ML performance studies to establish a consensus ground truth. For materials testing, the results are objectively measured against pre-defined 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

Not applicable. This is not an AI/ML device; it's a physical medical device (cannula) with a packaging change.

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

Not applicable. This is not an algorithm.

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

The "ground truth" in this context is based on objective measurements and established standards for:

• Product Functional Testing: Ensuring the device still operates as intended (e.g., fluid flow, connection integrity). This would involve engineering specifications and validated test methods.
• Biocompatibility Assessment: Ensuring the new packaging material does not cause adverse biological reactions. This is established by ISO standards (e.g., ISO 10993 series) and specific laboratory tests (e.g., cytotoxicity, sensitization).
• Shelf Life Study: Ensuring the device maintains its sterility and functional integrity over its claimed shelf life. This is established through accelerated and/or real-time aging studies and performance testing at various time points.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML product.

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

Not applicable. There is no training set.

Summary from the document regarding the "study" for the packaging change:

The "study" or rather, the design verification and validation activities performed to prove the device (with the new packaging) meets the acceptance criteria are summarized as:

• Risk-based testing and evaluations
• Product functional testing
• Biocompatibility assessment
• Completion of a product shelf life study

The conclusion explicitly states: "All results pass," thereby demonstrating that the modified DLP™ Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate devices and meet the necessary performance and safety standards despite the packaging change.

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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.

All medical devices pertaining to 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 phosphorylcholinebased biocompatible material.

The provided text describes a 510(k) premarket notification for Qura's Quantum Perfusion Dual Lumen Cannula, which introduces new REF codes (different sizes) and a warning in the Instruction for Use. It does not describe acceptance criteria for an AI/ML powered device or a study involving human readers or sophisticated ground truth establishment.

Therefore, most of the requested information (related to AI/ML device performance, reader studies, type of ground truth, training sets, etc.) cannot be extracted from this document, as it pertains to a medical device's physical and mechanical performance rather than an AI/ML algorithm.

However, I can extract the relevant information regarding the non-clinical testing for this specific medical device submission.

Here's what can be extracted based on the provided text:

Study and Acceptance Criteria Information (as per the provided document's scope):

The document describes the performance data and conclusions for new variants of a Quantum Perfusion Dual Lumen Cannula. The "study" here refers to the non-clinical bench testing conducted to demonstrate product safety and effectiveness for these new variants.

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

The document mentions "Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021" specifically, "Evaluation of devices' Pressure Drop." However, the specific acceptance criteria values (e.g., "Pressure drop must be less than X mmHg at Y flow rate") and the reported device performance values are not detailed in this summary. It only states that testing was performed "as per same internal applicable standards/protocols applied for predicate devices (K203067)."

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Quantum SuperPAC Tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours.
Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating.
Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.

This document is a 510(k) summary for the Quantum SuperPAC Tubing Set and Quantum SuperPAC Cardioplegia Set. It details the device's intended use, comparison to predicate devices, and performance testing. However, it does not contain information regarding studies that establish acceptance criteria for device performance in the manner of an AI/ML algorithm's effectiveness in diagnostic tasks, nor does it provide details on sample sizes, ground truth establishment, or expert adjudication typical for such studies.

Instead, this document focuses on demonstrating substantial equivalence to existing medical devices through non-clinical performance and biocompatibility testing for a medical device (tubing sets) rather than a diagnostic AI system.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical medical device.

Here's the breakdown based on the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the context of an AI/ML diagnostic system. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance tests conducted are listed as:

• Operating Parameters
• Mechanical Integrity
• Device pressure drop
• Spallation and Tubing Life
• Connection strength

These tests were mainly performed according to ISO 15676. Additional tests included:

• Evaluation of product shelf life (according to EP/UPS requirements)
• Validation of EtO Sterilization process (according to ISO 11135:2014)
• Packaging Validation tests (according to ISO 11607-1:2019, ASTM F1886/F1886M-16, EN 868-5 and ASTM F1929-15)
• Biocompatibility (according to ISO 10993-1:2018 and FDA Guidance)

The document asserts that the devices met these established requirements, implying that the acceptance criteria were defined by these standards and the device's performance aligned with them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring expert-established ground truth.

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

This information is not applicable as the document describes non-clinical performance testing for a physical medical 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 information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system.

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

This information is not applicable as the document describes a physical medical device, not an algorithm.

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

This information is not applicable for the type of device described. The "ground truth" for this device would be its adherence to performance specifications and safety standards as determined by the listed non-clinical tests (e.g., mechanical integrity tests, biocompatibility tests).

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not a machine learning model.

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

This information is not applicable as the document describes a physical medical device, not a machine learning model.

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