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510(k) Data Aggregation
(30 days)
The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
The Amplatzer™ Trevisio™ Intravascular Delivery System (ATV) is an extension of the Amplatzer TorqVue Delivery System (ITV) product line. This device is also referred to as "Flex Cable" on internal Abbott Medical documentation. The Trevisio Delivery System components are identical to the cleared ITV device which include a delivery system sheath, dilator, loader, hemostasis valve with extension tube and stopcock, delivery cable and plastic vise. In comparison to ITV, the cable component of the Trevisio Delivery System has been designed with a flexible distal tip to reduce bias when delivering an implant device; allowing physicians to more accurately assess placement prior to device release. Like ITV, the distal end of the sheath is offered in a 45° curve and is radiopaque for visibility under fluoroscopy.
The provided text describes a medical device, the Amplatzer™ Trevisio™ Intravascular Delivery System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen with AI/ML-driven medical devices.
The information given is for a traditional medical device (a catheter delivery system) and focuses on bench and laboratory testing to ensure functional and safety performance, as well as comparison to a predicate device. The document does not discuss:
- AI/ML algorithms or their performance metrics (e.g., sensitivity, specificity).
- Clinical studies involving human readers or AI assistance.
- Ground truth establishment in the context of diagnostic accuracy.
- Training or test set data for an AI model.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance from an AI/ML study, nor can I provide information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets, because this type of data is not present in the provided document.
The document discusses functional and safety testing for a physical medical device, not an AI/ML algorithm.
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(56 days)
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.
| Acceptance Criteria (Implied based on Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use Equivalence: Device provides a pathway through which devices are introduced within the chambers of the heart, similar to predicates. | The AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart, identical to predicate devices. |
| Technological Characteristics Equivalence: Similar design, materials, and manufacturing processes to predicates. | "The AMPLATZER™ TorqVue™ 45°x45° 80cm subject device...shares the same design (with the exception of being 80cm length versus 100cm), materials, accessories, and manufacturing processes as the predicate." |
| Functional & Safety Equivalence: Performs safely and effectively, with previous design verification and validation testing supporting equivalence. | "The intended use, components, materials and fundamental design of the TV45x45 80 cm are identical to the cleared predicate TV45x45 (100cm) device...Design Verification and Design Validation testing have been previously performed and provided in cleared applications for the predicate device." |
| Minor Design Changes (Length, Dilator Tip): The changes in length and dilator tip taper are considered not to raise new questions of safety or effectiveness. | The device is 80 cm (vs. 100 cm) and the 12 Fr dilator has an extended tip taper length modeled on the 14 Fr predicate dilator. This change is explicitly mentioned and considered acceptable. |
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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(83 days)
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:
| Acceptance Criteria (Functional/Safety Test Category) | Reported Device Performance (Implicitly Met) |
|---|---|
| Delivery Cable and Extension Wire Specific Tests | |
| Delivery Cable and Extension Wire Dimensional Tests | Conforms to dimensional requirements |
| Delivery Cable Vacuum Decay | Meets vacuum decay specifications |
| Extension Wire Connection Reliability | Demonstrates reliable connection |
| Delivery Cable Core Wire Distal Tip Flexibility | Meets flexibility requirements |
| Delivery Cable and Extension Wire Corrosion Testing | Demonstrates corrosion resistance |
| Delivery Cable Distal Torque to Failure | Meets torque to failure specifications |
| Delivery Cable Force Transmission | Demonstrates adequate force transmission |
| Delivery Cable Distal Core Tensile | Meets tensile strength requirements |
| Delivery Cable Core to Extension Wire Tensile | Meets tensile strength requirements |
| Delivery Cable Hub to Coil Tensile | Meets tensile strength requirements |
| Hemostasis Valve Leak Testing | Meets leak testing specifications |
| Device Interaction Testing with Other Components | |
| Advancement/Deployment Test | Successful advancement and deployment of devices |
| Recapture Test | Successful recapture of devices |
| Visual Inspection Post-Interaction Testing | No adverse visual changes post-interaction |
| Overall System Performance & Validation | |
| Design Validation Testing (animal study) | Successful performance in an animal model |
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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