Search Results

The Liberant Thrombectomy System is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.

The Liberant Thrombectomy System consists of the Liberant Thrombectomy Set (catheter, clotbuster, dilator, aspiration tubing and hemostasis valve), Liberant Blood Conservation Unit (BCU), Riptide Aspiration Pump and Riptide Collection Canister with intermediate tubing. The Liberant Thrombectomy Set is single use and provided sterile.

The Liberant BCU and Riptide Pump are provided separately from the Liberant Thrombectomy Set as non-sterile capital units. The single use, non-sterile Riptide Collection Canister is provided separately to the pump.

The provided FDA 510(k) clearance letter pertains to a thrombectomy system, which is a physical medical device (catheter-based system) used for removing blood clots. It is not an AI/ML device. Therefore, the request for acceptance criteria and study details relevant to AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document focuses on the substantial equivalence of the Liberant Thrombectomy System to a predicate device (Penumbra Indigo Aspiration System) based on:

• Indications for Use: Both systems are indicated for the removal of fresh, soft emboli or thrombi from peripheral arterial and venous systems.
• Operating Principle/Technological Design: Both utilize continuous aspiration and fragmentation tools (clotbuster/separator).
• Catheter Specifications: Similar sizes, lengths, and guidewire compatibility.
• Non-Clinical Data: Extensive performance, biocompatibility, shelf-life, sterilization, packaging, software validation (for the pump control), and electrical/EMC testing were performed. This type of "software validation" typically refers to embedded software controlling the pump mechanics, not an AI/ML diagnostic or predictive algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the provided document describes a non-AI medical device.

Ask a specific question about this device

The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.

The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters.

The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.

The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer quide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + SureValve™ Left-Heart Delivery System is available in two models: Attain Command TM + SureValve ™ 6250VC Left Heart Delivery System and Attain Command™ + SureValve™ 6250VS Left Heart Delivery System. With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.

The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models. Each model is different with respect to the guide catheter shape and length and dilator length.

The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities.

The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models. The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.

The provided text describes the 510(k) summary for several Medtronic devices: Attain Command™ + SureValve™ Left Heart Delivery System, Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery, and Attain Select™ II + SureValve™ Delivery Catheter System.

Based on the document, these devices did not undergo a study involving AI or algorithm performance. The acceptance criteria and "study" that proves the device meets them are entirely based on non-clinical performance data, comparing the new devices to existing predicate devices.

Here's the breakdown of the information requested, as it applies to this submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that the devices "met all specified design and performance requirements" and that biocompatibility tests "indicate that the devices are biocompatible for their intended use."

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

• Test Set Sample Size: Not specified for each individual non-clinical test. The document refers to "testing" and "validations" but does not provide specific numbers of units tested.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Non-clinical tests were conducted by Medtronic Ireland.

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

Not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is established through the results of non-clinical, laboratory-based tests (bench tests, biocompatibility tests, sterilization validations) against pre-defined engineering and safety specifications, and compliance with relevant ISO standards. There were no human experts evaluating performance in this context, nor was there a "ground truth" established by experts in the way it would be for an AI diagnostic device (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

Not applicable. This submission relies entirely on objective non-clinical test results rather than human judgments that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission does not involve AI or algorithms, nor does it include a clinical study (MRMC or otherwise).

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

Not applicable. This submission does not involve AI or algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering specifications and design requirements: For in vitro bench tests.
• International Standards (e.g., ISO 10993-1:2009 for biocompatibility, ISO 11135-1 and EN556-1 for sterilization): These standards define the acceptable methodologies and criteria for evaluating device properties.
• FDA Good Laboratory Practice (GLP) regulations (21 CFR, Part 58): For biocompatibility testing methodology.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

Ask a specific question about this device

The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre-dilatation catheter for enlarging coronary luminal diameters during PCI procedures.

The Medtronic Sprinter Legend 1.25mm RX and OTW are balloon dilatation catheters designed to perform Percutaneous Transluminal Coronary Angioplasty (PTCA).

Sprinter Legend 1.25mm RX
The device consists of a semicompliant balloon mounted on a Rapid Exchange delivery catheter. The Sprinter Legend 1.25mm RX device has an effective length of 142cm. It will be available in a single balloon diameter of 1.25mm and in balloon lengths from 6mm to 20mm.

Sprinter Legend 1.25mm OTW
The device consists of a semicompliant balloon mounted on an Over-the-Wire delivery catheter. The Sprinter Legend 1.25mm OTW device has an effective length of 152cm. Similar to Sprinter Legend 1.25mm RX, Sprinter Legend 1.25mm OTW will also be available in a 1.25mm balloon diameter and with balloon lengths from 6mm to 20mm.

This document describes the Sprinter Legend 1.25mm RX and OTW Balloon Dilatation Catheters for percutaneous transluminal coronary angioplasty (PTCA) procedures. It includes information on device description, indications for use, and a summary of a clinical study.

Here's an analysis of the provided text in relation to your questions:

Device: Sprinter Legend 1.25mm RX and OTW Balloon Dilatation Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are derived from its "Indications For Use" and the "Primary Endpoint" of the clinical study, which focuses on procedural success, device success, and lesion success. The reported device performance metrics are directly from the study results.

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

• Sample Size: 51 patients (54 lesions)
• Data Provenance: Prospective, multi-center, single-arm open-label study conducted at two (2) study sites in the United States. Clinical follow-up was conducted post-procedure until discharge.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth. However, it mentions "angiographic core lab data" being used, which implies review by qualified personnel specializing in angiographic analysis.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions "angiographic core lab data and if missing, site reported data" were used, which implies a hierarchical approach where core lab assessment is primary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a clinical study for a physical medical device (balloon dilatation catheter), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

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 is a physical medical device.

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

• Clinical outcomes: Directly observed procedural outcomes (e.g., successful delivery, absence of complications like arterial perforation or flow-limiting dissection, TIMI flow), device performance, and patient safety events (MACE, death, MI, etc.).
• Angiographic core lab data: For assessing aspects like TIMI flow and changes in Minimum Luminal Diameter (MLD).
• Site-reported data: Used to supplement angiographic core lab data when missing, particularly for TIMI and Perforation.

8. The Sample Size for the Training Set

This document describes a clinical study for a physical medical device; it does not mention a training set in the context of machine learning or AI. The study itself serves to demonstrate the safety and effectiveness of the device.

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

As there is no mention of a training set (in the context of AI/machine learning) for this physical medical device, this question is not applicable to the provided text.

Ask a specific question about this device

The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter.

The provided document is a 510(k) summary for the Medtronic Attain® 6227DEF Deflectable Catheter Delivery System. It describes a medical device and its substantial equivalence to a predicate device, as well as testing performed to support this equivalence.

However, this document does not contain information about the acceptance criteria or a study that uses AI/algorithm performance metrics such as sensitivity, specificity, or AUC, nor does it involve human readers, ground truth consensus, or training sets typical of a study proving a device meets acceptance criteria in an AI context.

Instead, this is a regulatory submission for a physical medical catheter delivery system, and the "study" referred to is device integrity testing and biocompatibility testing. The "acceptance criteria" generally refer to the design and performance requirements for the physical device, not a classification or diagnostic performance of an AI algorithm.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/algorithm performance studies based on the provided text. The document describes a traditional medical device clearance process, not one involving an AI component.

Here's an explanation of what the document does describe in terms of "acceptance criteria" and "studies":

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

• Acceptance Criteria (Implied): The device is expected to meet "all specified design and performance requirements" for a catheter delivery system. These would typically include:
  • Mechanical integrity (e.g., tensile strength, resistance to kinking, pushability, torqueability, deflection capabilities).
  • Functional performance (e.g., ability to introduce diagnostic/therapeutic transvenous devices and balloon catheters/leads effectively).
  • Biocompatibility (meeting ISO 10993-1 standards for limited exposure to circulating blood).
  • Sterility (achieving sterility through a validated EtO sterilization process).
• Reported Device Performance:
  • "The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements."
  • "The biocompatibility evaluation... verifies that the Attain® 6227DEF Deflectable Catheter Delivery System is biocompatible."
  • "The Attain® 6227DEF Deflectable Catheter Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process."

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not a data-driven AI test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to expert review of data, not physical device testing.

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. This document is not about AI assistance for human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI sense. For the physical device, the "ground truth" is adherence to engineering specifications and biological safety standards.

8. The sample size for the training set: Not applicable. This is not an AI model.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a medical device's compliance with safety and performance standards for regulatory clearance, not an AI-powered system's performance metrics.

Ask a specific question about this device

The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.

The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical

This document is a 510(k) summary for the Medtronic Attain Select™ II 6248DEL Delivery Catheter System. It describes the device, its intended use, and substantial equivalence to predicate devices. It also briefly mentions testing performed.

However, the provided text does not contain detailed information about specific acceptance criteria or the results of a study that quantifies compliance with those criteria for an AI/ML device.

The document states:

• "Device integrity testing was performed to support the equivalency of the Attain Select™ II 6248DEL Delivery Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ II 6248DEL Delivery Catheter System met all specified design and performance requirements."

This is a general statement that the device met its design and performance requirements, but it does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria in a quantitative manner.
3. Details on sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any study results directly applicable to acceptance criteria.
4. Any mention of AI, machine learning, or algorithms, let alone standalone performance or MRMC studies.

Therefore, I cannot provide the requested information from the given text because it is a submission for a delivery catheter system, not an AI/ML diagnostic device, and it does not detail specific acceptance criteria or performance study results in the manner you've requested. The document focuses on demonstrating substantial equivalence to predicate physical medical devices rather than the performance metrics of an algorithm.

Ask a specific question about this device