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The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The 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 Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device.

A. 24 Fr Venous Cannula
The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable 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.

B. Introducer
The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) 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 PVC material for visualization under fluoroscopy.

Below is the information regarding the acceptance criteria and study for the Protek Solo 24 Fr Venous Cannula Set, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices) used for each individual test. It consistently refers to "all tests" or testing of "the cannula, the introducer, and the cannula/introducer assembly," implying that a sufficient number of units were tested to draw conclusions.

The data provenance is from bench-top testing conducted by Cardiac Assist, Inc. The document does not specify the country of origin of the data beyond the company's location in Pittsburgh, Pennsylvania, USA. The studies are retrospective in the sense that they are assessing conformance against predetermined criteria, rather than a prospective clinical trial.

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

This section is not applicable as the document describes bench-top engineering and performance testing for a medical device (venous cannula and introducer), not a diagnostic or AI-assisted device that requires human expert review for ground truth establishment. The "ground truth" here is defined by engineering specifications and comparative performance against a predicate device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. The tests performed are objective physical and performance measurements, not subjective evaluations requiring adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging interpretation or other scenarios where human reader performance is being evaluated and compared, typically in the context of AI assistance. The described tests are for the physical and functional characteristics of a medical device.

Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device or study.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument (venous cannula and introducer), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for these tests was based on:

• Engineering specifications and design requirements for the new device.
• Comparative performance against legally marketed predicate devices (TandemHeart 21 Fr Venous Cannula and Protek Duo Veno-Venous Cannula Introducer), which serve as the established benchmark for safety and effectiveness for similar devices.

8. The Sample Size for the Training Set

This section is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.

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

This section is not applicable for the reasons stated above. There was no training set, as this is not an AI/ML 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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The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates, blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The TandemLung Oxygenator TLO consists of an injection molded exterior shell containing a bundle of Polymethylpentene (PMP) hollow fiber membranes in which blood is oxygenated and decarbonated. Sweep gas, primarily oxygen, is supplied to interior lumens of the fibers and diffuses from the fiber wall to the blood plasma via simple diffusion. Similarly, carbon dioxide diffuses from the blood into the inner lumen of the fibers and is exhausted. Arterialized blood exits out of the blood outlet port and is delivered to the patient.

A two part polyurethane "potting" compound is used to both mechanically fix the end of the hollow fiber membranes in place and to create a barrier between the blood and gas pathways within the TLO.

Use of the TLO requires use of a pump and cannula(s), as well as tubing and connectors/fittings.

This document does NOT contain information about a study based on AI/ML. The provided text is a 510(k) premarket notification for a medical device (TandemLung Oxygenator), which is a physical device, not an AI/ML algorithm. Therefore, I cannot extract the requested information as it pertains to AI/ML study methodologies, acceptance criteria for AI/ML performance, or human-in-the-loop studies involving AI.

The "Performance Data" section explicitly states: "In vitro bench tests were carried out to demonstrate performance and substantial equivalence to the predicate Novalung, according to the requirements of FDAs document 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submission', issued on November 13, 2000. Specifically hemolysis, gas exchange, pressure drop, blood pathway integrity, gas pathway integrity, and physical properties were tested."

This confirms that the testing was for a physical device's performance characteristics, not an AI/ML algorithm.

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The TandemHeart Venous Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator and dilator are intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support.

The TandemHeart Venous Cannula Set consists of three components, as shown in Figure 1: a 21 Fr. Venous Cannula. 14 Fr. Obturator, and an optional 14/21 Fr. Two-stage Dilator, that accepts a 0.035 in. guidewire. The device is intended to cannulate 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 cannulae are available in two configurations: 1. 21 Fr. x 62 cm. with options for tip curvature of 0° and 50° 2. 21 Fr. x 72 cm. with tip curvature of 50°. The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a 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 wirereinforced for visualization under fluoroscopy. Insertion depth markings are incorporated in the cannula body from 10 to 62 or 72 cm, depending on the length option, measured from the distal tip. The cannula includes a suture wing to provide a means for securing the cannula to the patient. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or the removal process. The 14 Fr. Obturator is provided to facilitate placement of the venous cannula, within the target vessel, and is designed with a tapered distal tip. The Obturator proximal end contains a luer hub to aid in the removal of the obturator. The Obturator body is constructed of a radiopaque material for visualization under fluoroscopy: The Obturator includes a hemostasis cap that provides the interface between the cannula proximal connector and obturator body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/obturator assembly into the target vessel. The 14/21 Fr. Dilator is provided to aid introduction of the obturator/cannula assembly at the insertion site.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TandemHeart Venous Cannula Set:

The provided text describes a 510(k) summary for the TandemHeart Venous Cannula Set. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria in the same way a novel device might. Therefore, the "acceptance criteria" here refer to the performance criteria used to validate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices or subjects. The studies were described as "non-clinical performance testing" and "in-vitro system capacity testing and flow vs. pressure drop (HQ)." For the other aspects (Flexibility, Strength, Biocompatibility, In-vitro Hemolysis, Leak testing, Sterilization, and Shelf Life), the text states they were "addressed by comparison with reference devices," implying that specific testing on the current device might not have been performed in a new study but rather leveraged existing data or demonstrated equivalence to devices already proven to meet these criteria.
• Data Provenance: The studies for flow characteristics were "in-vitro" (laboratory-based). For other characteristics, it relies on "comparison with reference devices," specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72, which were previously cleared by the FDA (K052570 and K082425). This suggests leveraging existing regulatory data from other devices by the applicant, rather than explicitly new "retrospective" or "prospective" clinical data for this specific device.

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

This section is not applicable as the studies described are non-clinical, in-vitro performance tests and comparisons to reference devices. There is no mention of human expert-based ground truth establishment for a diagnostic output.

4. Adjudication Method for the Test Set

This section is not applicable. There was no expert adjudication process described, as the studies are entirely non-clinical performance evaluations against engineering specifications or comparative data.

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 section is not applicable. The device is a medical cannulation set, not an AI-powered diagnostic tool, and therefore no MRMC study was performed.

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

This section is not applicable. The device is a medical cannulation set, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

• For Flow vs. Pressure Drop and System Capacity: The ground truth would be engineering specifications and performance data of the predicate device. The goal was to prove the new device performed "comparable to the predicate."
• For Flexibility, Strength, Biocompatibility, In-vitro Hemolysis, Leak testing, Sterilization, and Shelf Life: The ground truth was based on the established performance data and regulatory compliance of previously cleared reference devices (CardiacAssist Transseptal Cannula Set-EF and EF-72) and likely relevant international and national consensus standards for medical devices (though not explicitly named).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML model, so there is no concept of a "training set."

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

This section is not applicable for the same reason as above.

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The TandemHeart Transseptal Cannula Set-EF 72 is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Transseptal Cannula, a 14 Fr Obturator, and a 14/21 Fr Two-stage Dilator which are intended for the drainage of the left atrium during left ventricular bypass.

The provided text describes a 510(k) submission for a medical device, the CardiacAssist TandemHeart Transseptal Cannula Set-EF 72. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics as one might find in a full clinical trial report or a study evaluating an AI algorithm.

Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert consensus, and sample sizes for testing and training sets for an AI device are not applicable to this submission. This document pertains to a medical device's physical and functional characteristics.

However, I can extract the information that is relevant and map it to the closest corresponding categories where possible.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The "acceptance criteria" here are implicitly linked to the performance of the predicate devices. The study performed aims to demonstrate that the new device's performance aligns with or is substantially equivalent to these predicates.

Since this is a 510(k) summary for a physical medical device and not an AI algorithm, the following points are not directly applicable or inferable from the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. Performance data refers to bench testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): "Ground truth" in this context would be the measured physical and mechanical properties from the bench tests, compared against the known properties of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

The TandemHeart Escort (T.H.E) Controller is a microprocessor-based pump motor drive and infusion system. It is designed to operate on AC current (110/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The T.H.E Controller generates the signals required to power the drive motor of the TandemHeart Blood Pump, which turns the impeller to propel blood through the Pump. The system works independently of the heart. The Controller also serves to deliver the infusate into the TandemHeart Blood Pump and to provide information regarding system performance including measured flow. It is portable and designed to be pole mounted, hung from a horizontal bed rail, or placed on a table top. It is simple to use, with an integral backup motor control circuit, and backup batteries for redundant operation.

The provided text is a 510(k) summary for the TandemHeart Escort Controller, a medical device used for cardiopulmonary bypass. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria on clinical performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details) are not applicable or cannot be extracted from this document as no clinical performance study is described.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable / Not provided. This document describes a comparison to design specifications and predicate device characteristics, not a clinical study on a patient sample.
• Data Provenance: Not applicable / Not 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 / Not provided. No test set requiring expert-established ground truth is described.

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

• Not applicable / Not provided.

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 or reported. This device is a pump speed controller, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is hardware with integrated software for pump control, not a standalone algorithm in the typical sense of AI/ML. The performance review focused on the device's conformance to its specifications and equivalence to a predicate.

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

• Not applicable / Not provided. The "truth" used for comparison was CardiacAssist's own performance specifications, voluntary standards (EMC, electrical safety), and the established characteristics of the predicate device.

8. The sample size for the training set

• Not applicable / Not provided. As no AI/ML clinical performance study is described for this device, there is no "training set" in that context.

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

• Not applicable / Not provided.

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The TandemHeart Transseptal Cannula Set - EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

The TandemHeart Transseptal Cannula Set-EF consists of three components, as shown in Figure 1: (1) 21 Fr Transseptal Cannula, (2) 14 Fr Obturator, and (3) 14/21 Fr Two-stage Dilator. The Obturator and Dilator are designed to accept a standard 0.035 in. guidewire.

The 21 Fr Transseptal Cannula allows for drainage of the left atrium during left ventricular bypass. It has 14 side holes in addition to the tip opening for unimpeded inflow of blood at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Cannula also includes a Suture Wing to provide a means for securing the Cannula to the patient. The 21 Fr body of the Cannula includes a wire-reinforced area for clear visualization under fluoroscopy and for resistance to kinking. The wire-reinforcing also permits a thin-walled construction. This feature allows for a larger inside diameter (lumen) while maintaining the predicate CAI cannula's outside diameter. Consequently, greater flow can be achieved with the same pressure drop across the cannula versus the predicate CAI cannula. Printing on a region of the cannula which is not wire-reinforced indicates the area where a clamp should be applied as needed during the set-up or removal process. The distal end of the Cannula is curved for natural anatomical placement from the inferior vena cava into the left atrium. The printing on the cannula is oriented to show the clinician that the distal tip curves to the right when the printing is on the top of the cannula body.

The 14 Fr Obturator is used to advance the Cannula over a guidewire to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a Luer hub and flush side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to confirm final positioning of the Cannula. An hemostasis cap prevents excessive blood loss when the Cannula/Obturator assembly is inserted into the femoral vein. The Obturator body is fabricated of radionaly is fa for easy visualization under fluoroscopy.

The 14/21 Fr. Dilator is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique and a guidewire has been placed into the left atrium. The stepped design of the distal tip of the Dilator provides tactile feedbak to the clinician as the dilation is achieved. The Dilator is fabricated of radiopaque material for easy visualization under fluoroscopy.

The provided text describes a 510(k) summary for the CardiacAssist Transseptal Cannula Set-EF. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving that a new device meets specific acceptance criteria in terms of clinical performance as one might expect for an AI/ML device study.

Therefore, the requested information elements related to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this document. The provided text details the device's technical characteristics and performance testing against a predicate device to establish substantial equivalence.

Here's the information that can be extracted from the provided text, adapted to the closest relevant categories:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The "acceptance criteria" here are implicitly tied to demonstrating that the new device's performance is either "substantially better than," "met or exceeded," or "substantially equivalent to" the predicate devices. The study is a comparison to predicate devices, not an absolute measure against pre-defined clinical performance targets.

Information Not Applicable to this Document (for AI/ML devices)

1. Sample size used for the test set and the data provenance: Not applicable. This is a medical device comparison to predicates, not an AI/ML study. The "test set" would refer to the physical devices tested.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance tests (e.g., flow, strength) is based on engineering measurements, not expert consensus.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 intended for human reader assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing: engineering measurements/specifications of physical properties (e.g., flow rates, pressure drops, tensile strength, resistance to kinking, deflection properties).
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The study was a series of engineering and performance tests designed to compare the CardiacAssist Transseptal Cannula Set-EF against two predicate devices: the CardiacAssist Transseptal Cannula Set (K030398) and the MDT Biomedicus Femoral Cannula 96670-021 (K924642).

• Objective: To demonstrate "substantial equivalence" of the new device to the predicate devices in terms of design characteristics, performance, and intended use as required for a 510(k) submission.
• Assessment Methods:
  • Flow vs. Pressure Drop (HQ): Measured the flow characteristics and pressure drop of the new cannula, comparing it to the predicate CAI cannula.
  • Kink Radius Performance: Tested the device's resistance to kinking, comparing it to the predicate CAI cannula.
  • Tensile Strength: Evaluated the tensile strength of the Transseptal Cannula-EF and its obturator, comparing against predicate CAI cannula and obturator thresholds.
  • Leak Testing: Assessed the leak integrity of the Transseptal Cannula-EF, comparing against predicate CAI cannula thresholds.
  • Deflection Testing: Compared the deflection performance of the Transseptal Cannula-EF to the predicate CAI cannula.
  • Materials and Method of Construction: Explicitly stated comparison of the new cannula's materials (stainless-steel-wire-reinforced, polyurethane) and construction to the predicate MDT cannula.

The study concluded that the Transseptal Cannula Set-EF is substantially equivalent to the CardiacAssist Transseptal Cannula Set in design characteristics, performance, and intended use, and substantially equivalent to the predicate MDT cannula in materials and method of construction. This conclusion allowed the FDA to issue a substantial equivalence determination (K052570).

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The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.

The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

The provided text describes a 510(k) submission for the "CardiacAssist-Transseptal Cannula Set". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the device performance data provided is primarily based on bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing rather than human clinical trials. Therefore, information about human "test sets" or "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for bench testing. The "test set" would consist of multiple units of the manufactured device subjected to various engineering and materials tests. The document does not specify the exact number of units tested for each criterion, but it implies a sufficient number were tested to draw conclusions.

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 data presented is from bench testing, not from human studies requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests are objective measurements against established engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide interpretations that need to be reconciled. Bench tests rely on objective measurements and established protocols.

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

This is not applicable. The device is a physical medical instrument (a cannula set), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the bench tests described:

• Functional Performance (Flow vs. Pressure Drop, Kink Radius): The ground truth would be established by comparing the device's performance against the predicate device (Elecath cannula) and/or predetermined engineering specifications. The statement "substantially better than that of the Elecath cannula" indicates the predicate's performance served as a baseline or "ground truth" for comparison.
• Mechanical Strength (Tensile Strength) and Integrity (Leak Testing): The ground truth would be predefined engineering design requirements and specifications.
• Biocompatibility: The ground truth is compliance with recognized international standards and FDA guidance documents (FDA Blue Book Memorandum #G95-1 and ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical instrument, and the testing described is bench testing, not machine learning or AI where "training sets" are used.

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

This is not applicable for the same reasons as #8.

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The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusate system. The Pump is electrically driven and can only be used with the AB-180 XD Blood Pump Controller. The AB-180 XD Blood Pump Controller provides pump monitoring, manual pump speed variability and a constant flow of infusate to the Pump.

The AB-180 XC Blood Pump consists of an upper and lower housing. The upper housing encloses the blood contact area of the Pump and holds the impeller, which propels the blood through the Pump. This chamber has a low priming volume. Two tubes connect to this chamber allowing easy connection to extracorporeal circulatory support circuits. The lower housing contains the main rotating component (the rotor) and has an inlet port for the infusion fluid. This infusate acts as a fluid bearing and a local anticoagulation delivery system.

This 510(k) summary describes a submission for a Class III centrifugal blood pump. The review process concluded with a substantial equivalence determination to previously approved devices. Therefore, the device did not require a full clinical trial for approval. The acceptance criteria, study design and results from the provided text are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

• Hydraulic Performance Tests
• Safety and Environmental Tests (meeting IEC 60601-1, IEC 60601-1-2 and IEC 68 standards)
• Hemolysis Testing | Demonstrated substantial equivalence to commercially distributed centrifugal blood pumps, specifically the Medtronic BP-80 Bio-Pump®, across these tests. |
  | Biocompatibility | Must be biocompatible and non-toxic, safe for intended use. Testing performed in accordance with FDA Blue Book Memorandum - G95-1 and appropriate sections of Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1. | Testing demonstrated the device is biocompatible and non-toxic, thus safe for its intended use. No biocompatibility issues associated with the infusate. |
  | Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$.
  EtO dissipation curves must assure residual concentrations of ethylene oxide and ethylene chlorohydrin meet limits in ANSI Standard Number ANSV/AAMI/ISO 10993-7:1995. | Sterilization validated to achieve SAL of $10^{-6}$.
  EtO dissipation curves confirm compliance with residual concentration limits. |
  | Pyrogens | LAL testing performed, and release criteria must be in accordance with the December 1987 Guideline of the FDA, Office of Compliance (Guideline of Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices). | LAL testing performed and meets the specified release criteria. |

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

The provided text only discusses in-vitro bench testing and does not mention human subject clinical trials or imaging data. Therefore, the concept of "test set" as typically understood in AI/ML performance evaluation (i.e., human-annotated data) is not applicable here. The "samples" would refer to the physical devices or components tested in the lab.

• Sample size for bench testing: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for demonstrating substantial equivalence.
• Data Provenance: The data is generated from in-vitro bench testing conducted in a laboratory setting by Cardiac Assist Technologies, Inc. There is no mention of country of origin for human data, as no human data was used. All testing appears to be retrospective in the sense that it evaluates the manufactured device against pre-defined standards and a predicate device.

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

Not applicable. This was a medical device approval based on in-vitro bench testing and comparison to a predicate device, not on AI/ML diagnostic performance evaluation. Therefore, there was no "ground truth" derived from expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable, as there was no expert review or human-in-the-loop assessment requiring adjudication for this type of device approval.

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

Not applicable. This device is a centrifugal blood pump, not an AI diagnostic/assistant tool. 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 a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval was established by:

• Engineering and Performance Standards: Adherence to established international and national standards for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, IEC 68, ISO 10993-1, ANSI/AAMI/ISO 10993-7:1995).
• Predicate Device Performance: Direct comparison of the AB-180 XC Blood Pump's in-vitro performance (hydraulic, safety, environmental, hemolysis) against the established performance of the legally marketed predicate device, the Medtronic BP-80 Bio-Pump®.
• Biocompatibility Standards: Compliance with FDA Blue Book Memorandum - G95-1 and ISO 10993-1.
• Sterilization Standards: Demonstration of a $10^{-6}$ SAL and compliance with EtO residual limits.
• Pyrogen Standards: Compliance with FDA's 1987 Guideline for LAL testing.

8. The Sample Size for the Training Set

Not applicable. There was no machine learning model or "training set" involved in the approval of this hardware medical device.

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

Not applicable. No training set was used.

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