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The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.

Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.

The provided document is a 510(k) premarket notification letter and supporting documentation for the Protek Venous Dilator Sets. It focuses on demonstrating substantial equivalence to a predicate device for a medical dilator. This type of document does not include information related to acceptance criteria, study details, expert involvement, or statistical analysis typically found in an FDA submission for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the requested information for this specific document because it describes a physical medical device (dilator) and not a device that relies on AI/ML or requires a complex validation study with acceptance criteria related to diagnostic performance.

The document details non-clinical testing for the dilator, such as:

• Tensile Strength: "Pull test with objective acceptance criteria." Conclusion: "All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application."
• Deflection Test: "Compliance measurement with side-by-side comparison to similar sized predicate devices." Conclusion: "The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed."
• Biocompatibility: "Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours." Conclusion: "All tests passed."

This is the extent of the "acceptance criteria" and "study" information available in this document. It does not fit the format of an AI/ML-driven diagnostic study.

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The TandemHeart 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 TandemHeart Veno-Venous Cannula Set consists of two components: a 29 Fr. Dual lumen Veno-Venous Cannula and a 13 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The TandemHeart Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The TandemHeart 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 cannula has printed insertion depth markings every 10 centimeters from 10 to 30 cm followed by every 2 centimeters for the remainder of the insert-able length, measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.

The introducer (Figure 2) consists of a tube with a 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 material for visualization under fluoroscopy.

The provided document is a 510(k) summary for the TandemHeart Veno-Venous Cannula Set. This type of regulatory submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving efficacy or performance against specific clinical acceptance criteria in the manner requested.

Therefore, the document does not contain the requested information about acceptance criteria, a human clinical study, or AI performance metrics.

Here's what can be extracted from the document regarding the device's evaluation, and why it doesn't align with the request:

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

• This information is not present. The document discusses general performance testing but does not detail specific acceptance criteria or quantitative performance tables.

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

• The document describes "non-clinical performance testing" using "in-vitro system capacity testing and flow vs. pressure drop (HQ)." This indicates it was not a human clinical study and therefore has no human "test set" in the sense of a patient cohort. The "sample size" would refer to the number of devices or experimental setups, which is not specified.
• Data provenance (country, retrospective/prospective) is not applicable as it's not a clinical study.

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

• This is not applicable as there was no human clinical "test set" requiring expert ground truth establishment.

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

• This is not applicable as there was no human clinical "test set" and thus no adjudication of clinical outcomes.

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 device is a medical cannula, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI performance metrics are not applicable.

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

• This is not applicable as the device is not an algorithm or AI system.

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

• For the non-clinical performance testing, the "ground truth" would be established by engineering and chemical principles, likely against a set of predetermined engineering specifications for flow rate, pressure drop, flexibility, strength, biocompatibility, etc. These specific "ground truths" and their methods are not detailed in the summary.

8. The sample size for the training set:

• Not applicable as there is no AI component or machine learning "training set."

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

• Not applicable as there is no AI component or machine learning "training set."

Summary of what is available from the document:

The document states that "Non-clinical performance testing was conducted to demonstrate substantial equivalence of flow characteristics between the TandemHeart Veno-Venous Cannula and the predicate, Medtronic Avalon Elite." It also mentions "Flexibility, strength, biocompatibility, in-vitro hemolysis, leak testing, sterilization, and shelf life" were addressed.

The conclusion drawn from this testing was that "Based on the performance test results and data from the predicate devices, the TandemHeart Veno-Venous Cannula was found to meet established design input requirements and thus to be substantially equivalent to the predicate Avalon Elite Dual Lumen Veno-Venous Cannula."

In conclusion, this document describes the regulatory clearance of a physical medical device (a cannula) based on substantial equivalence to predicate devices, primarily through non-clinical, in-vitro testing. It does not involve AI, human clinical trials with specific acceptance criteria as you've outlined, or ground truth established by medical experts for a diagnostic task.

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The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

The 15 French TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1: a 15 Fr. Femoral Arterial Cannula and a 10 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device.

The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip.

The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process.

The 10 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer body is also constructed of a radiopaque material for visualization under fluoroscopy.

The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.

This submission K133293 describes a medical device, the 15 French TandemHeart Femoral Arterial Cannula Set, and its substantial equivalence to predicate devices, but it does not include a study that defines or demonstrates acceptance criteria in the manner requested (e.g., using performance metrics like sensitivity, specificity, or accuracy based on human-AI comparison).

The document details non-clinical performance testing conducted to show substantial equivalence for a physical medical device (cannula), not a diagnostic algorithm or AI-powered system that would typically have acceptance criteria presented as performance metrics against ground truth.

Therefore, for your specified questions, I can only provide information based on the type of testing described in the document, which focuses on physical and functional characteristics of the cannula.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that "All performance tests were conducted on both the 15 French TandemHeart Femoral Arterial Cannula Set and the applicable control device... Based on the performance test results, the TandemHeart Femoral Arterial Cannula Set was found to meet the established design input requirements as well as to perform comparably to the predicate devices."

The acceptance criteria are implicitly defined by "established design input requirements" and "perform comparably to the predicate devices." No numerical targets or specific performance metrics are provided in the document for these tests, nor are the detailed results.

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

• Sample Size for Test Set: Not specified in the document. The testing involved "in-vitro" (laboratory) conditions not patient data.
• Data Provenance: In-vitro non-clinical testing. Not applicable for country of origin or retrospective/prospective as it's not clinical data.

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 the "ground truth" for this type of device (cannula) is based on engineering specifications and physical performance measurements (e.g., flow rate, kink resistance, leak proofing) in a laboratory setting, not expert clinical interpretation of data.

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

Not applicable. This concept applies to expert consensus on clinical findings, not to in-vitro engineering 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 for AI-powered diagnostic devices, not a physical medical device like a cannula.

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

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device.

7. The type of ground truth used:

The "ground truth" (or reference standard) would be the established engineering specifications for flow rates, material properties, and mechanical integrity tests (e.g., kink resistance, hemolysis limits, leak limits).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device design and manufacturing processes are developed based on engineering principles and prior device experience, not a data training set.

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

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/machine learning device.

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The Femoral Arterial Cannula and Introducer is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

The TandemHeart Femoral Arterial Cannula Set consists of two components: a 17 Fr. Femoral Arterial Cannula and a 12 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device. The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip. The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process. The 12 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer. The introducer body is also constructed of a radiopaque material for visualization under fluoroscopy. The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.

The provided text describes the 510(k) summary for the TandemHeart Femoral Arterial Cannula Set, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in the context of an AI/human reader study.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text, as they pertain to clinical studies or AI/diagnostic device performance evaluations that are not present. The document focuses on non-clinical performance testing to demonstrate substantial equivalence, which is a different type of evaluation.

Here's a breakdown of what can be extracted and what cannot:

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)

• Cannot be determined from the provided text. The text mentions "non-clinical performance testing" and "in-vitro" tests, but does not specify sample sizes or data provenance.

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)

• Cannot be determined from the provided text. This information is relevant for clinical or diagnostic studies, not the non-clinical engineering tests described.

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

• Cannot be determined from the provided text. This is relevant for expert-based ground truth establishment, which is not 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, an MRMC study was not done. The device itself is not an AI/diagnostic tool, but a medical device (cannula).

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

• No, a standalone algorithm performance study was not done. The device is a physical medical device, not an algorithm.

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

• For the non-clinical performance tests, the "ground truth" would be established engineering specifications and benchmarks against the predicate device. For biocompatibility, it refers to standard biological response criteria. There is no expert consensus, pathology, or outcomes data mentioned in the context of ground truth.

8. The sample size for the training set

• Cannot be determined from the provided text. There is no "training set" in the context of this type of device submission.

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

• Cannot be determined from the provided text. There is no "training set" or corresponding ground truth establishment process described.

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The TandemHeart pump is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The TandemHeart System consists of two major components, the Escort Controller (K061369), and the TandemHeart Blood Pump (K991783), along with a number of accessory components required to setup and utilize the Pump. The system is intended for extracorporeal circulatory support using an extracorporeal bypass circuit.

The provided document is a 510(k) summary for the TandemHeart System, a non-roller type cardiopulmonary bypass blood pump. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

Based on the available text, here's what can be extracted and what cannot:

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

   • Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For the specific performance test mentioned, the implicit acceptance criterion was that the TandemHeart System demonstrate "adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."
   • Reported Device Performance:
     • "The HQ testing results demonstrated adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."

   Table:

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: Not specified. The document mentions "subsequent testing of the TandemHeart System" for "flow vs. pressure drop (HQ)," but does not provide details on the number of units tested, the duration of tests, or any patient data sample sizes.
   • Data Provenance: Not specified. As the testing was to verify performance, it's likely internal lab testing, but specific country or retrospective/prospective nature regarding patient data is not applicable/provided.

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 mechanical blood pump, not an AI/diagnostic imaging device. "Ground truth" in the context of expert review or clinical outcomes is not pertinent to the "flow vs. pressure drop" testing described.

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

   • Not applicable. This is not a study involving expert adjudication for diagnostic accuracy. The performance testing described (flow vs. pressure drop) would likely involve objective measurements against engineering specifications or comparative measurements with a predicate, not expert 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

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. This is a mechanical device.

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

   • For the "flow vs. pressure drop (HQ)" testing, the ground truth would be based on physical measurements and engineering principles, likely comparing the device's performance against established specifications or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

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

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

   • Not applicable. As above, this is a mechanical device, not an AI system.

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