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The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Each ProtekDuo Veno-Venous Cannula Set includes a dual lumen cannula and an introducer. The introducer is designed to accept a standard 0.038-inch guidewire. The ProtekDuo Veno-Venous Cannula Sets are intended as single patient, single use, sterile devices.

Each ProtekDuo Veno-Venous Cannula consists of two (2) distinct lumens, each made of polyurethane with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body is the smaller diameter lumen with six (6) side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal of the cannula from the extracorporeal circulatory support equipment. A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8-inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has two suture wings that can be used for securing the cannula in place to the patient. The cannulas also have printed insertion depth markings measured from the distal tip.

Each introducer consists of a tube and hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque polyvinyl chloride material for visualization under fluoroscopy.

This document describes the premarket notification (510(k)) for the ProtekDuo Veno-Venous Cannula Sets, asserting their substantial equivalence to legally marketed predicate devices. The information provided outlines the device's technical characteristics, its intended use, and the non-clinical testing performed to demonstrate its performance.

However, the provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the context of an AI/human reader performance study. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to existing devices, primarily through non-clinical testing and an in vivo animal study. It does not mention any AI component or human reader performance evaluation.

Therefore, I cannot fulfill the request to provide information based on the input about:

• A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
• Sample sized used for the test set and data provenance (for an AI/human reader study)
• Number of experts used to establish ground truth and qualifications (for an AI/human reader study)
• Adjudication method (for an AI/human reader study)
• MRMC comparative effectiveness study, effect size
• Standalone (algorithm only) performance study
• Type of ground truth used (for an AI/human reader study)
• Sample size for the training set (for an AI)
• How ground truth for the training set was established (for an AI)

The document's "acceptance criteria" are related to regulatory conformity (e.g., biocompatibility, sterility, mechanical integrity) and "performance" refers to the device's physical and functional characteristics (e.g., flow rates, tensile strength) demonstrated through non-clinical bench testing and an animal study, not human or AI diagnostic performance.

Based on the provided document, here's what can be extracted regarding the device's acceptance criteria and proof of performance:

The acceptance criteria for the ProtekDuo Veno-Venous Cannula Sets are primarily defined by the Special Controls outlined in 21 CFR 870.4100 for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. The study proving the device meets these criteria is a series of non-clinical tests (bench tests) and an in vivo animal study.

1. Table of Acceptance Criteria (Special Controls) and Reported Device Performance:

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

• Test Set (Non-Clinical/Bench Testing): Specific sample sizes for each non-clinical test (e.g., number of cannulas tested for tensile strength, number of setups for pressure/flow) are not detailed in this summary. However, these would be standard engineering test sample sizes to ensure statistical validity for the specific tests performed (e.g., according to ISO standards or internal validation protocols).
• Test Set (In Vivo): The summary mentions a "14-day in vivo evaluation" in a "biologic test system." The specific number of animals used for this study is not provided in this document.
• Data Provenance: The testing appears to be conducted by the manufacturer or contract research organizations as part of their regulatory submission for the device. The country of origin for the data is implied to be related to the applicant's location (Pittsburgh, PA, USA) or its testing facilities. It is a prospective set of tests and studies specifically performed for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as this submission is for a medical device (cannula) based on physical and biological performance, not an AI or diagnostic imaging device requiring expert reader ground truth.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by physical measurement standards, engineering specifications, and established biological/material compatibility protocols (e.g., ISO standards for biocompatibility, flow dynamics equations for pressure/flow).
For the in vivo animal study, the "ground truth" would be the observed physiological function and integrity of the device within the biologic system over the 14-day period.

8. The Sample Size for the Training Set: Not applicable, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

This document is a 510(k) Summary for the MC3 Crescent™ Jugular Dual Lumen Catheter. It outlines the device's indications for use, description, comparison to a predicate device, and how it conforms to Class II Special Controls.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one might expect for diagnostic accuracy or clinical outcomes. Instead, it discusses conformance to "Special Controls" and mentions various types of testing to demonstrate "substantial equivalence."

Based on the information provided, the "acceptance criteria" can be inferred from the "Class II Special Controls" and the general requirements for substantial equivalence. The "device performance" is described qualitatively as meeting these controls.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (Jugular Dual Lumen Catheter K180151) rather than proving novel clinical efficacy or diagnostic accuracy as might be seen for AI-driven diagnostic devices. The performance metrics are related to safety, material compatibility, and engineering design rather than clinical outcome improvements attributable to the device itself beyond its function in ECMO.

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

The document describes various types of testing but does not provide specific sample sizes for each test mentioned (e.g., "non-clinical performance," "in vivo evaluation," "biocompatibility").

• Non-clinical Performance: Mentions "bench" testing, "mechanical integrity," and "30-day durability." No specific sample size is given.
• In vivo Evaluation: Mentions "7-day in vivo thrombogenicity evaluation." No specific sample size is given, nor is the species used.
• Biocompatibility: Refers to ISO 10993-1:2009 and GLP (21 CFR 58). These are standards for testing, but they don't specify the sample size used in this particular submission.

Data Provenance: The data is generated from various tests (bench, in vivo, etc.) conducted by the manufacturer (MC3 Incorporated). The document does not specify the country of origin for the data or if it's retrospective or prospective, as these are typically controlled laboratory and animal studies, not patient data in the context of this device.

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

This information is not provided in the document. The tests described are laboratory and animal studies, not typically involving human expert adjudication for "ground truth" in the way a diagnostic AI would.

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

This information is not provided and is not applicable to the types of engineering and biocompatibility tests described for this 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a physical medical device like a catheter.

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

This question is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy is not directly applicable here. For the various tests performed, the "truth" is established through:

• Bench Test Results: Measured physical and mechanical properties against pre-defined specifications.
• Biocompatibility Standards: Adherence to established ISO and GLP guidelines.
• In vivo Evaluation: Biological responses (e.g., thrombogenicity) observed in an animal model, measured against expected safety profiles.

8. The sample size for the training set

This is not applicable. The MC3 Crescent™ Jugular Dual Lumen Catheter is a physical medical device, 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 there is no training set for this type of device.

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The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are bi-caval dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous surgical methods (Seldinger type approach). The introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The introducer hub provides an area for grasping the introducer during insertion and when fully seated, indicates that the introducer is fully inserted. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. The catheters remain intact throughout the duration of use and withstand the forces associated with insertion, securement, connection to perfusion line, clamping, blood pressures, and removal.

This document describes the premarket notification for a medical device and provides information on its performance evaluations, but it does not contain acceptance criteria or a study proving the device meets those criteria in the context of diagnostic or AI-driven performance.

The document is a 510(k) summary for the MC3 Jugular Dual Lumen Catheter, which is a physical medical device (a catheter) used for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). The "performance evaluations" mentioned are for the physical characteristics and safety of the catheter itself (e.g., durability, flow, kink resistance, biocompatibility, sterility), not for a diagnostic algorithm or AI system's output.

Therefore, I cannot provide the requested information from the provided text, as it pertains to a different type of device and different evaluation criteria than what your questions imply (e.g., questions about ground truth, expert consensus, MRMC studies, standalone algorithm performance, training/test sets are relevant for AI/diagnostic devices, not for a physical catheter's mechanical performance).

If you have a document related to an AI/diagnostic device, please provide that.

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The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 31/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 QuickFlow Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature by normal access techniques. The introducer is designed to follow a pre-positioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The catheter is wire-reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter has radiopaque markers at the tip and most proximal set of drainage holes.

The devices are comprised of two separate thin-walled catheters made of silicone and polyurethane polymer and reinforced with a spring wire. The dual lumen design involves two catheters of different diameters joined together in a co-axial configuration. An arrangement of side holes in the outer (drainage) catheter allows for egress of blood. An open tip on the inner (return) catheter allow s for blood ingress. Unreinforced tube extensions with barbed connectors, allowing clamping and connection to the extracorporeal circuit, are joined to the wye junction. A tapered tip introducer is included to facilitate placement of the catheter into the blood vessel over a standard guide wire (not included). Securement of the device may be accomplished via a groove designed in the Y-connector to accept a suture and a suture around a 3/8" barb connector.

The provided text describes the MC3 QuickFlow Dual Lumen Catheter and its equivalency to a predicate device, focusing on its physical characteristics, intended use, and performance evaluations. However, it does not contain information related to an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

The document is a 510(k) premarket notification for a medical device (a catheter), and the performance evaluations listed are typical for such hardware devices (durability, pressure/flow, kink resistance, etc.). There is no mention of "AI", "algorithm", "human readers", "MRMC", "ground truth" in the context of an AI-driven study, or any other terms that would suggest an AI/ML component.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text, as the text pertains to a non-AI medical device.

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The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual lumen Veno-Venous Cannula and a 15.5 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The PROTEK Duo 31 Fr. Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels. The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.

The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

The provided document is a 510(k) premarket notification for a medical device called the PROTEK Duo 31 Fr. Veno-Venous Cannula Set. This document is a regulatory submission to the FDA, not a study publication. Therefore, it does not describe an AI/ML-based device or a clinical study in the typical sense for AI/ML validation.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) tests performed to demonstrate the substantial equivalence of the new device (PROTEK Duo 31 Fr.) to a legally marketed predicate device (PROTEK Duo 29 Fr.). The device in question is a physical medical device (cannula), not a software algorithm.

Based on the provided information, here's a breakdown of the requested points as they apply to this document:

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

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

• Sample Size: The document does not specify exact sample sizes for each benchtop test (e.g., how many cannulas were tested for hemolysis, tensile strength, etc.). It generally refers to "tests" and "all tests," implying multiple units were tested.
• Data Provenance: The tests are non-clinical, benchtop tests performed by the manufacturer, CardiacAssist, Inc., located in Pittsburgh, PA, USA. Therefore, the data provenance is from internal laboratory testing within the USA. It is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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 question is not applicable to this document. The "ground truth" for these non-clinical tests is based on objective physical measurements and engineering specifications, not expert interpretation or clinical outcomes. For example, hemolysis is measured by laboratory methods, tensile strength by force gauges, and flow rates by fluid dynamics measurements. No human experts are used to establish ground truth in this context.

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

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers or experts interpret data (e.g., medical images) and their disagreements need resolution. For physical benchtop tests, results are typically quantitative and objectively measured, not subject to subjective 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 question is not applicable to this document. This submission is for a physical medical device (cannula), not an AI/ML-based medical device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This question is not applicable to this document. As stated, this is a physical medical device, not an algorithm.

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

As explained in point 3, the "ground truth" here refers to the actual physical properties and performance of the device under controlled benchtop conditions, measured objectively using established engineering and laboratory test methods. It's based on physical measurements against established specifications and comparison to a predicate device's performance, not clinical ground truth types like pathology or outcomes data.

8. The sample size for the training set

This question is not applicable. This submission is for a physical medical device. There is no AI/ML algorithm that requires a "training set." The device itself is manufactured; it does not "learn."

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

This question is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to be established for it.

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These devices are to be used by a trained physician only. Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to faciliate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus" cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.

The adult venous and arterial cannulae consist of a polyurethane wirewound body with a multiport distal tip. The adult venous cannula also has a multi-port body built with stainless steel wirewinding and reinforced baskets. All adult arterial cannulae come with a vented 3/8-in vented connector and all of the adult venous come with a non-vented 3/8-in connector. The overall length of the cannulae is 12.5-in for the adult arterial/jugular and 25.6-in, 26.5-in and 30in for the adult venous. The Adult cannulae come with a repositionable suture ring that is radiopaque. Insertion depth marks aid in positioning the cannula. The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance. The Adult Cannula and Introducer package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (Sizes 23 - 29 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½-in cardio pulmonary bypass circuit. Sterile, nonpyrogenic, single use.

The provided text describes the regulatory clearance of a medical device, the "Bio-Medicus Adult Cannulae and Introducer," and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, quantitative performance results, or a detailed study description suitable for populating the requested table and answering all questions about a specific study proving device meets acceptance criteria.

The document primarily focuses on:

• Regulatory clearance (510(k) submission): This is about demonstrating "substantial equivalence" to existing devices, not necessarily proving absolute safety or efficacy against pre-defined performance thresholds in the way a clinical trial would.
• Device description and intended use.
• Comparison to predicate devices: Highlighting similarities and minor differences.
• Summary of performance data: Listing the types of pre-clinical bench and animal testing performed, but without providing the actual results, acceptance criteria, or methodology details of these tests.

Therefore, I cannot fully complete the requested table or answer all questions as the necessary detailed information is not present in the provided text.

Here's what can be extracted and what information is missing:

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

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

• Sample size: Not specified. The document only mentions "Pre-clinical bench testing" and "Animal testing."
• Data provenance: "Pre-clinical bench testing" and "Animal testing." No country of origin is specified. The nature of the testing (bench and animal) implies it's prospective for the specific tests conducted.

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

• Not applicable. This device is a physical medical instrument (cannula and introducer) cleared based on pre-clinical and animal testing, not on interpretation of medical images or diagnostic outputs that would require expert ground truth labeling.

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

• Not applicable. (See answer to #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

• No. This is not an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• For physical device testing, "ground truth" would typically be derived from engineering standards, validated measurement methods, or physiological parameters observed in animal models. The document doesn't detail the specific benchmarks or "ground truth" for each test type (e.g., what constitutes acceptable blood trauma, pressure drop, or cannula life). It only states that the device "performed as well or better than the legally marketed devices," implying a comparison against established performance of the predicate.

8. The sample size for the training set

• Not applicable. This is not a machine learning device that requires a training set.

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

• Not applicable. (See answer to #8)

Missing Information Summary:

The provided document is a 510(k) clearance letter and summary. It lists the types of tests performed (Blood Trauma, Sterilization, Biocompatibility, Packaging, Pressure Drop, Cannula Life, Cannula and Introducer, Cannula, Introducer, Securement Clip Testing) but does not include:

• Specific quantitative acceptance criteria or threshold values for any of these tests.
• The actual test results in a quantitative format.
• Details on the methodology (e.g., number of units tested, duration, specific metrics measured, statistical analyses).
• Details of the "Animal testing" beyond its mention.

Without these specifics, it's impossible to fully describe "the study that proves the device meets the acceptance criteria" in terms of explicit criteria and reported performance values. The clearance hinges on the conclusion that it performed "as well or better than the legally marketed devices" based on these unspecified tests.

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