Search Results

The SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

The SpeedLyser Infusion Catheter Kit includes a variety of related components including:

• 0.018" Guidewire .
• 21 Gauge Entry Needle
• Non-Vented Caps (2)
  The SpeedLyser catheter consists of the outer 5F catheter and an occluding 3F catheter. The outer 5F catheter is designed with slits along the shaft to provide optimal distribution of lytic over a thrombosed graft length.

The provided text is a 510(k) summary for the AngioDynamics SpeedLyser Infusion Catheter Kit. This type of document is for a medical device that is not an AI/ML (Artificial Intelligence/Machine Learning) powered device. Therefore, the specific information requested about acceptance criteria, study details, expert involvement, and ground truth, which are typically relevant for AI/ML device evaluations, is not present in this document.

The document describes a modified AngioDynamics SpeedLyser catheter and demonstrates its substantial equivalence to a predicate device through non-clinical bench testing.

Here's a breakdown of what can be extracted, and what cannot:

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

Note: The document states "Based upon successful results of testing," implying that the device met the acceptance criteria for each test, but the specific numerical acceptance criteria (e.g., "tensile strength greater than X N") and the exact reported performance values are not provided.

2. Sample size 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 as it's not relevant for a mechanical device undergoing bench testing. The "test set" here refers to the physical units of the device tested, not a dataset in the context of AI.

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 provided. "Ground truth" in this context would typically refer to the "true" physical properties or performance defined by standards, not expert labels on a dataset. The testing was physical bench testing, not an evaluation of an AI algorithm.

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

This information is not provided. Adjudication methods are typically used for expert review of data (e.g., medical images) to establish ground truth for AI model training or evaluation. This is not applicable to the bench testing of a physical catheter.

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 provided. An MRMC study is designed for AI/ML devices that assist human readers (e.g., radiologists). The SpeedLyser Infusion Catheter is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

This information is not provided. A standalone algorithm performance evaluation would be for an AI/ML device. This document describes a physical medical catheter.

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

For the bench tests, the "ground truth" would be established by engineering standards and specifications for the physical properties being measured (e.g., a specific tensile strength value that new catheters must meet). The document implicitly states that these standards were met ("successful results of testing"), but does not detail the specific standards or the process of defining the ground truth values.

8. The sample size for the training set

This information is not provided. "Training set" is a concept for AI/ML models. This is a physical device, and thus no AI training set exists.

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

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

In summary, the provided document describes a traditional medical device (a catheter) and its evaluation through non-clinical bench testing to demonstrate substantial equivalence to a predicate device. It does not pertain to an AI/ML medical device, and therefore most of the requested information regarding AI/ML-specific evaluation criteria and study details is not present.

Ask a specific question about this device

The ANGIODYNAMICS SpeedLyser Infusion Catheter and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Not Found

The provided text is a set of FDA 510(k) clearance letters for the Angiodynamics SpeedLyser Infusion Catheter Kit. These letters do not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The documents indicate that the device (SpeedLyser Infusion Catheter Kit) was reviewed for substantial equivalence to legally marketed predicate devices. This regulatory process typically involves demonstrating that a new device is as safe and effective as a predicate device, but it doesn't usually include detailed performance acceptance criteria and a study report in the way a clinical trial or performance study for a novel device would.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The FDA 510(k) clearance process primarily focuses on substantial equivalence based on indications for use, technological characteristics, and safety/effectiveness data compared to a predicate device, rather than a detailed performance study against pre-defined acceptance criteria as might be seen for AI/ML-based medical devices or novel technologies.

Ask a specific question about this device