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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 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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