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The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.

The Alligator™-HD Retrieval Device (ARD-HD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with an off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD-HD device are made of radio opaque material facilitating fluoroscopic visualization. The ARD-HD is for single use only.

The provided text is a 510(k) summary for the Alligator™-HD Retrieval Device. It is a submission for a medical device to demonstrate substantial equivalence to a legally marketed predicate device, not a clinical study report of a new device's performance against detailed acceptance criteria.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, or ground truth establishment for a diagnostic algorithm.
• Information on expert panels (number, qualifications, adjudication methods) for establishing ground truth.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Sample size for training sets or how their ground truth was established.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, function, manufacturing, materials, indications, packaging, sterilization, and labeling. It explicitly states that "The information presented in the 510k shows that the Alligator™-HD Retrieval Device, ARD-HD is substantially equivalent to predicate endovascular snare devices in regards to the following aspects."

This type of submission typically relies on non-clinical performance data (e.g., bench testing, biocompatibility, sterilization validation) to support the safety and effectiveness claims, rather than clinical efficacy studies with human subjects and diagnostic performance metrics like sensitivity, specificity, or reader improvement.

In summary, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it argues for substantial equivalence to existing devices.

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The Marksman™ Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.

The provided text is a 510(k) summary for the Marksman™ Catheter, detailing its design, indications for use, and a declaration of substantial equivalence to predicate devices. This document does not describe or include an acceptance criteria table, device performance data, or a description of a study proving device performance against acceptance criteria.

Instead, the document states:

• Substantial Equivalence Determination: The safety and effectiveness of the Marksman™ Catheter are based on its substantial equivalence to predicate endovascular catheters. The conclusion of substantial equivalence is drawn from comparisons in design, function, manufacturing, materials, indications, packaging, sterilization, and labeling.
• Clinical Evaluation: A clinical evaluation was conducted to show that "no new risks were identified and that the safety and effectiveness profile is similar to well-established predicate devices cleared for the market." This evaluation was performed in the neurovascular anatomy, considered the "worst case representation of the cardiac and peripheral vascular anatomies."

Since the document does not present specific quantitative acceptance criteria or detailed study results, I cannot fill in the requested table or provide information for most of the points about a specific performance study.

Here's what can be inferred or explicitly stated based on the provided text, acknowledging the limitations due to the lack of a detailed performance study section:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions a "clinical evaluation," but provides no details on participant numbers.
• Data Provenance: Not specified, but likely prospective as it refers to a "clinical evaluation" conducted to confirm safety and effectiveness for the specific device being submitted.

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

• Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical evaluation focuses on comparing the device's safety and effectiveness profile to existing predicate devices.

4. Adjudication method for the test set:

• Not applicable. No details about an adjudication method are provided.

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 device is a catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used:

• Not explicitly stated as "ground truth" in the context of an accuracy study. The "clinical evaluation" aimed to demonstrate that the device's "safety and effectiveness profile is similar to well-established predicate devices." This implies that the 'truth' or benchmark was the known safety and effectiveness of existing, legally marketed catheters.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" in the context of an algorithmic or AI model.

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

• Not applicable. There is no mention of a "training set" or its ground truth.

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The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.

The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.

The provided text describes a 510(k) summary for the Alligator™ Retrieval Device (ARD) and its comparison to predicate devices, but it does not contain information about acceptance criteria, device performance studies, or the specifics of such studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document focuses on demonstrating substantial equivalence to predicate devices, material safety (biocompatibility), and basic performance attributes like weld strength and force-to-open, without outlining clinical or a specific performance study with defined acceptance criteria.

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