Search Results

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.

The provided document is a 510(k) summary for the Warrior 14 guidewire, a medical device. It does not describe an AI/ML device or a study comparing AI performance against acceptance criteria. Instead, it details the substantial equivalence determination process for a traditional medical device (a guidewire) based on biocompatibility and bench testing.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI is not applicable to this document. The document focuses on the physical and material properties of the guidewire and its comparison to a predicate device.

However, I can extract the acceptance criteria and performance data for the guidewire as presented in the document, which are primarily related to safety and performance through bench and biocompatibility testing.

Here's a summary of the relevant information provided in the document:

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)

This information is not provided in the document. The document refers to "biomaterial tests" and "verification tests" but does not specify the sample sizes (e.g., number of guidewires tested for each bench test) or data provenance. These are typically internal lab tests conducted by the manufacturer.

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 information is not applicable as the document describes a physical medical device (guidewire) and its bench/biocompatibility testing, not an AI device requiring expert ground truth for image or data interpretation.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable as the document describes a physical medical device (guidewire), not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI algorithm.

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

For the biocompatibility tests, the "ground truth" is established by the specified standards (ISO 10993-1) and the observed biological responses. For the bench performance tests, the "ground truth" is the established engineering specifications and measurement results. These do not involve expert consensus in the typical sense of diagnostic interpretation.

8. The sample size for the training set

This information is not applicable as the document describes the testing of a physical medical device (guidewire), not an AI/ML model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

Boston Scientific Hornet, Hornet 10, and Hornet 14 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

The Hornet, Hornet 10, and Hornet 14 Guidewires are designed to facilitate the placement of interventional coronary devices such as dilating balloon catheters, stent delivery systems and other coronary artery diagnostic or therapeutic devices. The guide wires are available in a nominal diameter of 0.014 inches and nominal lengths of 190 cm and 300 cm. The 190 cm guide wires are compatible exclusively with the Stretch Extension Wire which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the guide wire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guide wire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. All wires are available in a straight tip configuration.

This document describes the Hornet Guidewire, Hornet 10 Guidewire, and Hornet 14 Guidewire, intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. The submission is for a 510(k) premarket notification (K152231), indicating it's a medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted for the device. However, it does not explicitly state specific quantitative acceptance criteria or detailed results for each test. It broadly states that "The result of the test provides reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use" and "No new safety or performance issues were raised during the testing."

Here's a table based on the listed performance tests, acknowledging the lack of specific numerical acceptance criteria and performance data in the provided text:

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

The document lists various "Design verification testing" and "biocompatibility tests" that were performed. However, the specific sample sizes used for these tests are not provided in the document. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

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 device appears to be a physical medical instrument (guidewire) and the testing described is primarily benchtop and biocompatibility testing, not diagnostic AI or image analysis. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic studies is not applicable in this context. The evaluation relies on standardized engineering and biocompatibility test methods and their predetermined acceptance criteria.

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

As mentioned above, since this is mechanical and biocompatibility testing of a physical device, not an interpretive diagnostic study, the concept of an "adjudication method" involving multiple human readers is not applicable. The results are determined by the outcome of the physical tests against established 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. The Hornet Guidewire is a physical interventional device, and its evaluation focuses on its mechanical properties and biocompatibility.

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 type of study is specifically for evaluating artificial intelligence algorithms. The Hornet Guidewire is a physical medical device.

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

For this medical device, the "ground truth" for proving its safety and effectiveness is established through adherence to predetermined engineering specifications, validated test methods (aligned with standards like EN ISO 11070 and relevant guidance documents like Coronary & Cerebrovascular Guide Wire Guidance January 1995), and generally accepted biocompatibility endpoints. The results of these tests against established limits and benchmarks serve as the "ground truth."

8. The sample size for the training set:

Not applicable. The Hornet Guidewire is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through traditional engineering methods.

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

Not applicable. As stated above, this is a physical medical device, not an AI algorithm, so there is no training set or ground truth for training in this context.

Ask a specific question about this device

The BridgePoint Medical Entera guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The Entera guidewires are not to be used in cerebral blood vessels.

The Entera is a conventionally constructed 0.014" diameter single use disposable guidewire that consists of a full length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes coaxially positioned coils, constructed of stainless steel and Pt/W for visibly under fluoroscopy. The coils are fixed to the stainless core via silver alloy solder and are optionally coated with silicone (Lake Region Medical MDX). The distal tip of the guidewire is supplied in a straight or angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0032" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the Entera rounded tip.

This document is a 510(k) summary for a medical device called the BridgePoint Medical Entera™ Percutaneous Coronary and Peripheral Guidewire. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results is generally not present in this type of regulatory submission.

Specifically, the document does not contain any information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details of a study proving the device meets acceptance criteria.
3. Number of experts, their qualifications, or adjudication methods for ground truth because no such study addressing acceptance criteria is described.
4. A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects of AI assistance.
5. Standalone algorithm performance, as this is a physical medical device, not an AI algorithm.
6. The type of ground truth used, as no study requiring ground truth is detailed for performance assessment.
7. Sample size for a training set or how ground truth was established for a training set, as these concepts relate to AI/ML models, which this device is not.

The document states that the BridgePoint Medical Entera™ Guidewire is "substantially equivalent" to existing predicate devices (Lake Region PTCA guidewire/Triumph, Cordis/Brivant, Ltd. Regatta Steerable Guidewire, and Asahi PTCA Guidewire Confianza Pro). The arguments for substantial equivalence are based on:

• Intended Use: All devices are designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA/PTA.
• Method of Operation: The Entera is a conventionally constructed guidewire.
• Technical Aspects:
  • It is a 0.014" diameter single-use disposable guidewire with a full-length stainless steel shaft, proximal PTFE coating, and a taper-ground distal portion for flexibility.
  • The distal portion includes coaxially positioned coils of stainless steel and Pt/W for fluoroscopic visibility.
  • The coils are fixed via silver alloy solder and can be silicone-coated.
  • The distal tip can be straight or angled, transitioning to a rounded tip.
  • Key difference and justification for equivalence: The Entera has a 0.0032" diameter, 0.007" long narrowed extension on its distal tip, unlike the standard 0.014" distal tip of the Triumph. However, this narrowed tip is stated to be "substantially equivalent" to the narrowed distal tip geometries of the Cordis Regatta (which has a non-conventional "wedge shaped" tip substantially less than 0.014") and the Asahi Confianza Pro (which tapers to 0.009" diameter).
  • The distal-most portion of the Entera core wire (under the distal coil) has a round cross-section, while the Triumph has a flattened/ribbon cross-section.
  • The Entera and Triumph are manufactured by the same company (Lake Region Medical) and use the same component materials with "very similar physical attributes (flexibility, radiopacity, etc.)."

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a study designed to explicitly meet predefined performance acceptance criteria.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.

The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria are not explicitly stated or defined. The submission focuses on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:

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

This information is not provided in the document. The submission references "bench testing" but does not detail the sample sizes of devices or test conditions.

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

This information is not applicable as the document describes a medical device (guide wire), not an algorithm or diagnostic tool that requires expert-established ground truth on a test set (e.g., medical images). The testing appears to be physical or mechanical bench testing.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. The device is a physical medical instrument (guide wire), not a diagnostic algorithm where human readers assess cases.

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

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

7. The Type of Ground Truth Used

For this device, the "ground truth" would relate to its physical and functional properties meeting specifications. The document states:

• "Biocompatibility": Demonstrated by a "long history of use in medical devices" for its components. This implies a historical record of safe and successful use in similar applications.
• "Functioning as intended": Established through "bench testing." This likely involves engineering specifications and performance metrics for parameters like tensile strength, flexibility, lubricity, etc. However, the specific parameters are not detailed in the summary.
• "Substantial equivalence": Established by comparing its characteristics and materials to previously cleared predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary of the Study and Acceptance:

The submission for the Asahi PTCA Guide Wire (K052339) is a 510(k) premarket notification, which aims to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

The "study" described is primarily focused on bench testing to demonstrate:

• The device's materials are the same as existing predicate devices and have a long history of biocompatible use.
• The device functions as intended.
• The device's characteristics are substantially equivalent to the specified (presumably for the predicate devices) specifications.

The acceptance criteria, while not quantified with specific thresholds, are met by demonstrating this substantial equivalence and satisfactory performance in bench testing, allowing the FDA to conclude that the device is as safe and effective as its predicates. The FDA's acceptance is conveyed in the letter from November 30, 2005, stating that the device is "substantially equivalent."

Ask a specific question about this device