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The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) is an extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45 100cm) product family (K120120 and K083214) and is available in both a 12Fr and 14Fr sheath size.

The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths with the exception of having a shorter 80 cm length and the tip taper length of the 12Fr (80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm) dilator.

The 80 cm length is consistent with several TorqVue Delivery System products including the TorqVue™ Delivery system (ITV) cleared under submission K072313 and the TorqVue™ (TVLA) delivery sheaths cleared under submission K120120.

Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flush adapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies the following essential components:
Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip.
Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy.
Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.

The document provided is a 510(k) summary for a medical device (AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath). However, it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device. This document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for new medical devices in the US, rather than proving performance against specific acceptance criteria through a clinical or performance study with a test set, ground truth, and expert interpretations.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document as it pertains to a different type of regulatory submission.

Here's what can be gathered, largely in the context of a substantial equivalence claim:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or report specific performance metrics in the way an AI/ML device study would (e.g., sensitivity, specificity, accuracy). The "performance" demonstrated here is primarily through a comparison to a predicate device and functional/safety testing, asserting that the new device performs equivalently and safely.

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

Not applicable. This document does not describe a test set or data provenance in the context of evaluating an AI/ML algorithm. The equivalence is established through engineering and design comparisons, and prior testing of predicate devices.

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

Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is a traditional medical device submission, not an AI/ML device study.

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

Not applicable. No adjudication method is described as there isn't a test set requiring expert consensus.

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

Not applicable. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed or described.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This document relies on regulatory standards, engineering principles, and prior verification/validation for predicate devices, rather than a "ground truth" in a clinical study sense for a novel diagnostic or AI device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device.

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The AMPLATZER™ TorqVue™ LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.

The provided text is a 510(k) Summary for a medical device (AMPLATZER TorqVue Low Profile Delivery Catheter). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not include information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way an AI/ML device would be evaluated.

The document is a submission to the FDA for market clearance, not a study report. It focuses on demonstrating equivalence to existing devices rather than proving novel performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of data.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes functional and safety testing as being performed and provided in cleared applications for predicate devices, implying that the current device leverages those existing approvals for its components.
2. Sample sized used for the test set and the data provenance: Not applicable. The document refers to "Design Verification and Design Validation testing" performed on predicate devices, but doesn't specify test set sizes or data provenance for the current device's performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of information is not relevant for the kind of device and submission described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human assessment of outcomes for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance in a clinical setting for this type of device. The "ground truth" would be engineering specifications and safety standards for the functional components.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The AMPLATZER® TorqVue FX Delivery System is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER® TorqVue® FX Delivery Systems (also referred to herein as ITV FX) are general purpose delivery systems designed to provide a pathway through which devices are introduced within the chambers of the heart. The ITV FX Delivery Systems are an extension of the AMPLATZER TorqVue (ITV) Delivery System product line. The technological characteristics of the ITV FX are the same as the predicate devices, with the following differences: The TorqVue FX Delivery System contains a flex . delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The flex cable assembly provides rigidity for advancing devices through the sheath and allows the core wire to be extended out of the coil to provide flexibility for confirming correct placement of the deployed device. The Torq Vue FX Delivery System contains an 0.035" . compatible extension wire, which is only used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a larger sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The ITV FX Delivery System sheath will be offered with a 45° curve with a 60-cm useable length (6Fr, 7Fr, 8Fr) or 80-cm usable length (7Fr, 8Fr. 9Fr. 10Fr, 12Fr, 13Fr) and will be recommended for use with a subset of the AMPLATZER occluders that currently recommend the Torq Vue (45°) Delivery Systems. The ITV FX Delivery System includes a delivery sheath, dilator, delivery cable, extension wire, loader, delivery cable vise, two hemostasis valves, and for the 10, 12 and 13Fr products a flush adaptor to enable connection with syringes for flushing the sheath lumen. The sheaths are radiopaque for visibility under fluoroscopy.

The AMPLATZER® TorqVue® FX Delivery System is a catheter delivery system. The information provided describes the device's technical characteristics, its comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.

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

The document does not explicitly list "acceptance criteria" in a quantified manner with corresponding "reported device performance." Instead, it states that "Results from testing of the proposed and predicate devices show the proposed device conforms to the requirements for its intended use." The testing performed serves as the basis for this conformance.

Here's a table summarizing the tests performed, which implicitly served as the "acceptance criteria" through successful completion:

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

The document does not specify the exact sample sizes (e.g., number of units, number of tests for each type) used for the bench and laboratory testing. It broadly states "Bench and laboratory testing was performed."

The data provenance is from bench and laboratory testing, indicating controlled environments. There is one mention of an "animal study" for "Design Validation Testing." The country of origin for the data is not explicitly stated but is implied to be within the US, given the submitter's location (Plymouth, MN) and the FDA submission process. All studies appear to be prospective as they were conducted to support the submission.

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

This section is not applicable as the described testing does not involve human interpretation or subjective assessment that would require expert consensus for ground truth. The tests are primarily engineering and performance-based, with results measured against predetermined specifications.

4. Adjudication method for the test set

This section is not applicable for the same reasons as #3. The testing involves objective measurements rather than subjective interpretations requiring 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 section is not applicable. The device is a physical medical device (catheter delivery system), not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is irrelevant.

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

This section is not applicable. As a physical medical device, the concept of "standalone algorithm performance" is not relevant. The device itself is the "standalone" entity whose physical and functional performance is being evaluated.

7. The type of ground truth used

The "ground truth" for the acceptance criteria is based on engineering specifications, design requirements, and established industry standards for medical device performance and safety. For example, a "Tensile Test" would have an established maximum force the component must withstand, which serves as its ground truth. The "animal study" would have defined success metrics related to device delivery and placement.

8. The sample size for the training set

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

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

This section is not applicable for the same reason as #8.

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The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.

The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a micro screw attachment at one end for attaching to the delivery wire. The device is an extension of the previously approved AMPLATZER Vascular Plugs and has the identical indications for use: arterial and venous embolizations in the peripheral vasculature.

Included in the AVP4 device package are:
• Loader - consisting of two tubes, one inside the other with a stainless steel spring attached to extend the inner retractable tube
• Delivery Wire - comprised of a PTFE covered coil with core wire and attached end screw

The provided text describes a 510(k) summary for the AMPLATZER® Vascular Plug 4, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in the same way an AI/ML device would. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies (MRMC) for AI performance is largely not applicable or not present in this type of document for this device.

However, I can extract and restructure the information that is relevant to the performance data and the study performed to demonstrate substantial equivalence for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

For medical devices like the AMPLATZER® Vascular Plug 4, acceptance criteria are typically related to meeting established standards for safety, biocompatibility, and functional performance that demonstrate equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The device performance is reported as successful completion of these tests, indicating conformance to requirements for its intended use.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comprehensive set of bench testing (in-vitro) and animal studies (in-vivo) designed to demonstrate substantial equivalence to predicate devices (AMPLATZER® Vascular Plug II and AMPLATZER® Vascular Plug II Extended Sizes). The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

The following points address the specific questions from your prompt, acknowledging that many are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a vascular plug.

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

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

   • Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like an AI model. For in-vivo studies, specific numbers of animals (canine and porcine) were used, but the exact count for each study is not provided in this summary document.
   • Data Provenance: The in-vivo studies were conducted using canine and porcine models. This is prospective animal study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image interpretation) is not relevant for this device. The "ground truth" here is the physical and biological performance observed in laboratory and animal studies, assessed by engineers, scientists, and veterinarians against pre-defined safety and performance parameters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for expert review in clinical trials or AI validation where subjective interpretation is involved. For this device, objective measurements and observations from animal studies and bench tests determine performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (vascular plug), not an AI/ML diagnostic or assistive tool for human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For in-vitro tests, the ground truth is based on engineering specifications, material standards, and established physical/chemical properties. For in-vivo animal studies, the "ground truth" is derived from direct biological observations, histological analysis, and physiological measurements in the animal models, assessed against pre-defined safety and performance endpoints for embolization devices.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and prior knowledge from the predicate devices.

9. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are validated through the specified bench and animal testing.

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The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°. The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length. The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the AMPLATZER® TorqVue® Delivery Sheaths.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes various functional and safety tests performed on the AMPLATZER TorqVue Delivery Sheaths to demonstrate their substantial equivalence to a predicate device. The document does not explicitly state numerical "acceptance criteria" for each test but implies that the device "conforms to the requirements for its intended use" if the tests are passed.

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

The document mentions "Bench and laboratory testing" and "Design validation testing (animal study)". However, it does not specify the sample size for the test set used for these various tests. It also does not provide data provenance (e.g., country of origin, retrospective or prospective) for any of the studies, beyond stating that they were "Bench and laboratory testing" and an "animal study."

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any of the described tests. The tests appear to be primarily engineering and animal model-based, rather than human expert-driven interpretation.

4. Adjudication Method for the Test Set:

Given the nature of the bench, laboratory, and animal studies described, an adjudication method is not mentioned and is likely not applicable in the same way it would be for studies involving human interpretation or clinical outcomes. The tests appear to have objective pass/fail criteria based on engineering specifications or physiological responses in the animal model.

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. The document describes bench, laboratory, and animal studies to demonstrate substantial equivalence, not a clinical study involving human readers and interpretations. Therefore, no effect size for human readers improving with or without AI assistance is provided.

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

This device is a physical medical device (catheter delivery system), not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable.

7. The Type of Ground Truth Used:

The ground truth for the bench and laboratory tests would have been established by engineering specifications, material properties, and performance standards for medical devices of this type. For the "design validation testing (animal study)," the ground truth would be based on physiological responses, procedural success, and absence of adverse events observed in the animal model, as determined by veterinary experts and scientific observation.

8. The Sample Size for the Training Set:

This device is a physical medical device, and the described studies are for its functional and safety validation. There is no concept of a "training set" as would be used for machine learning or AI algorithms.

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

As there is no "training set" in the context of this device and its validation, this question is not applicable.

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The AMPLATZER TorqVue Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature. The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy. The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) summary for the AMPLATZER® TorqVue® 2 Delivery Sheath, a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling typical "acceptance criteria" and "studies" in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested points related to AI software performance (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance, provenance of data) are not applicable to this type of device and submission.

Here's an analysis based on the information provided:

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

For this device, "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm would have sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various functional and safety characteristics. The reported "performance" is that it met these criteria through bench testing.

Study Title: Not explicitly named, but referred to as "Bench testing" and "laboratory verification test."

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 for Test Set: Not specified. Bench testing often involves a statistically determined number of units or replicates for each test, but the exact numbers are not detailed in this summary.
• Data Provenance: The testing appears to be internal "bench testing" and "laboratory verification tests" performed by the manufacturer, AGA Medical Corporation, in Plymouth, MN, USA.
• Retrospective/Prospective: As this is bench testing of physical properties, these terms are not applicable in the typical clinical study sense. The tests are designed and executed prospectively in a lab setting.

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 is a physical medical device (delivery sheath), not an AI algorithm requiring expert interpretation for "ground truth" on images or clinical data. The "ground truth" for its performance is derived from standardized engineering tests measuring physical properties.

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

• Not Applicable: As above, this is bench testing of a physical device. There is no "adjudication method" involving experts for a test set in the context of clinical interpretation or diagnosis. Test results are objective measurements against predetermined specifications.

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

• Not Applicable: This is a physical medical device, not an AI algorithm. Therefore, MRMC studies are not relevant.

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

• Not Applicable: As this is a physical medical device, not an algorithm, the concept of "standalone performance" for an algorithm is not relevant.

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

• Ground Truth Type: For a physical device, the "ground truth" is defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "ground truth" for tensile strength would be a defined force threshold, or for kinking, a specific angle of bend without occlusion. These are objective, measurable physical properties.

8. The sample size for the training set

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

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

• Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.

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The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.

The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® 3 Delivery Sheath. This document primarily focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical study data involving human performance or specific acceptance criteria for a diagnostic AI device.

Therefore, the requested information, which is typically associated with AI/ML diagnostic device studies, cannot be fully extracted or is not applicable in this context.

Here's an attempt to answer based on the provided text, highlighting where the information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria or specific numerical performance metrics for a diagnostic device. Instead, it states that the functional characteristics were determined to be "substantially equivalent" to predicate devices. The bench tests are described generally.

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

• Sample Size: Not specified. The document refers to "bench testing" which typically involves a small, representative sample of devices for engineering tests, not a large clinical test set.
• Data Provenance: Not applicable. The data is from laboratory (bench) testing of the device itself, not from clinical data (e.g., patient records, images).

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

Not applicable. This device is a delivery sheath, not a diagnostic device requiring expert review for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or diagnostic decision-making involved in the bench testing 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. This is not an AI/ML diagnostic device, and no MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is not an AI/ML algorithm; it is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on engineering specifications, material properties, and functional performance benchmarks (e.g., resistance to kinking, tensile strength, leakage) as determined through bench testing. It's not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and prior regulatory approvals of similar predicate devices.

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The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER® TorqVue® 45°x45° Delivery Sheath is a sterile, singleuse, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the chambers of the heart. The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has a usable length of 100 cm and is available in 9 Fr, 10 Fr, 12 Fr, and 13 Fr sizes (inner diameter). A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are curved approximately 45° in two dimensions, resulting in a three-dimensional geometry. The 10 Fr, 12 Fr, and 13 Fr sizes also include a flush adapter that facilitates connection of accessories to the proximal end of the sheath. The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of two segments of different Pebax materials to provide support for device advancement and tip flexibility for vessel engagement. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) submission for the AMPLATZER® TorqVue® 45°x45° Delivery Sheath. My analysis will focus on extracting information related to acceptance criteria and the study that proves the device meets them, based on the provided document.

Acceptance Criteria and Device Performance

Note: The document explicitly states that "Bench testing of the AMPLATZER TorqVue® 45°x45° Delivery Sheath included verification of the distal curve dimensions after sterilization, distribution simulation, and six-month accelerated aging." While specific quantitative acceptance criteria values are not provided, the conclusion is that these tests demonstrated substantial equivalence, meaning the performance met the specified (though unquantified in this summary) criteria.

Study Information

1. 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 explicitly stated. The document refers to "Bench testing" without specifying the number of units tested for each criterion.
   • Data Provenance: Not specified. The testing described is "Bench testing," which typically occurs in a controlled laboratory environment. There is no information on human or animal data, country of origin, or whether it was retrospective or prospective.

2. 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. The study involved "Bench testing" of physical device characteristics, not clinical assessment requiring expert interpretation for ground truth.

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

   • Not applicable. This type of adjudication is typically used for clinical interpretation or subjective assessments, not for objective bench testing of device characteristics.

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

   • No. The study performed was "Bench testing" of a medical device (delivery sheath), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and effect sizes for human reader improvement are not relevant.

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

   • Not applicable. This is not an algorithmic device; it is a physical medical device.

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

   • The ground truth for the "Bench testing" was derived from predefined engineering specifications and performance standards to establish substantial equivalence with the predicate device. These standards would dictate acceptable ranges for dimensions, stability after sterilization, and aging performance.

7. The sample size for the training set

   • Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

   • Not applicable, as there is no training set for this device.

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The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.

The provided text describes a 510(k) summary for a medical device, the AMPLATZER TorqVue Exchange System. This is a submission for substantial equivalence to a predicate device, not a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission.

The study described is a device verification study to demonstrate that the AMPLATZER TorqVue Exchange System meets established performance criteria and supports equivalency to a predicate device.

Here's the information that can be extracted or deduced from the provided text:

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 in the document.
• Data Provenance: Not specified, but typical for device verification is in-house testing by the manufacturer (AGA Medical Corporation, Plymouth, MN, USA). The study is prospective in nature, as it involves testing the device against specific criteria.

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 is not applicable as the study described is a device verification study for a delivery system, not a diagnostic or AI device requiring expert-established ground truth. The "ground truth" here is the established performance criteria for the device itself.

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

• Not applicable. The verification testing would involve standardized test methods and measurement, not expert adjudication in the context of diagnostic interpretation.

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 is not relevant for this type of medical device (catheter delivery system). This device does not involve "human readers" or "AI assistance."

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

• Not applicable. This device is not an algorithm. The "standalone" performance refers to the device's ability to meet its functional and safety requirements independently. The listed "visual, performance and compatibility testing" assesses this.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is the established performance criteria and specifications for a catheter delivery system, derived from engineering standards, regulatory requirements, and comparison to the predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm and does not have a "training set."

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

• Not applicable.

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The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.

The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:
• Delivery Catheter - used to deliver transvenous devices
• Loader- used to help introduce the selected implantable device into the delivery catheter
• Delivery Wire (optional) – attaches to the implantable device and facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.]
• Plastic Vise (included with delivery wire) – a handle that is attached to the Delivery Wire by means of a set screw
• Hemostasis Valve- used on the proximal end of the Loader to minimize bleeding from the Delivery Catheter and for flushing air from the system

Here's an analysis of the provided text regarding the acceptance criteria and study for the AMPLATZER® TorqVue® Low Profile Delivery System:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices." The specific numerical acceptance criteria (e.g., "kink resistance must withstand X N of force") and the exact performance values (e.g., "kink resistance withstood Y N") are not provided in this summary. The evaluation is made against a predicate device, seeking "substantial equivalence."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Verification and validation testing" and "laboratory verification tests and in vitro performance information."

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

This information is not provided in the document. The studies described are primarily laboratory and in vitro performance tests, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as the described tests are laboratory and in vitro performance assessments, not studies requiring human expert adjudication of results.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant to this device. This device is a medical delivery system, not an AI-powered diagnostic or assistive tool for human readers.

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

A standalone performance evaluation in the context of an algorithm or AI was not performed or described. This is a medical device, not a software algorithm. The "standalone" performance here refers to the device's functional characteristics tested in a lab setting, which were indeed conducted without human operator variables, beyond basic operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was established through objective laboratory measurements and in vitro performance evaluations against pre-defined engineering and performance specifications, likely derived from the predicate device's characteristics or internal design requirements. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A training set typically refers to data used to train machine learning models, which is not relevant here.

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

This information is not provided and is not applicable as there is no mention of a training set or machine learning in the context of this device.

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