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The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (

The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.

The provided text describes a medical device, the "Mini-Midline™ Extended Dwell Safety Catheter," and its substantial equivalence to predicate devices, but does not include acceptance criteria for a study demonstrating AI/algorithm performance. The document focuses on regulatory approval (510(k) submission) for a physical medical device, not a software algorithm.

Therefore, most of the requested information regarding AI/algorithm performance (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, MRMC studies, standalone performance) cannot be extracted from the provided text.

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

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

This information is not present for an AI/algorithm-based device. The document lists "Technical Characteristics" and "Performance Data" for the physical catheter.

However, the document does list technical characteristics and performance data for the physical device:

Technical Characteristics and Performance Data (for the physical catheter):

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Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.

This document is a 510(k) Summary for a medical device called the "Luther Safety Huber Needle Set," submitted by Luther Needlesafe Products, Inc. It details the device's characteristics and its substantial equivalence to a predicate device, as required for FDA clearance.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

Key Observation: The provided document is a 510(k) summary, which is a pre-market notification to the FDA. Its purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It does not contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment, or performance metrics in the way you've requested. The focus is on comparing the new device's technological characteristics to the predicate device.

Therefore, I will answer your questions based only on the information available in the provided text. Many of your questions cannot be answered with the given document.

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of a detailed study proving performance against those criteria is not explicitly present in this 510(k) summary.

The document indicates that the new device (Low Profile Luther Safety Huber) has substantially equivalent technological characteristics to its predicate device (Luther Safety Huber Needle Set, K021565). This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, rather than specific performance metrics against pre-defined targets.

The changes in the new device are minor: "Overall height of device is lower" and "Clear body of device allows user to check insertion." The document states:

"The old and the new design have similar technological characteristics and are equivalent."

"There is no change in the following items:

• Indications for Use
• Patient contact or fluid path materials
• Safety activation feature
• Instructions for Use
• Sizes and options for gauge, length and needless Y site"

Therefore, the "device performance" reported is its equivalence to the predicate device, implying it performs no worse and maintains the safety and effectiveness of the previously cleared device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) summary):

Study Details Not Present in the Document:

The provided 510(k) summary does not contain information about a specific study that quantifies device performance against detailed acceptance criteria in the way your questions imply (e.g., sample sizes, ground truth, experts, MRMC studies, standalone algorithm performance).

Here's why each of your specific points cannot be fully addressed by this document:

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. 510(k) summaries of this nature typically do not include detailed study designs or data provenance. The assessment is usually based on design comparisons and existing predicate device data.
2. 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): Not applicable/Not provided. This document does not describe a study involving human experts establishing ground truth for performance.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
4. 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 mechanical Huber needle set, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is purely mechanical.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. The "ground truth" for a 510(k) for a simple mechanical device like this is typically a comparison to the predicate device's mechanical specifications, design, and intended use, rather than clinical outcomes or expert consensus on diagnostic tasks. The claim of "aiding in the prevention of accidental needle sticks" would have been established for the original predicate device through appropriate testing (e.g., simulated use, sharps injury rates if applicable, but details are not in this document).
7. The sample size for the training set: Not applicable/Not provided. This is not an AI or machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) pre-market notification. It demonstrates "substantial equivalence" between a new medical device (Low Profile Luther Safety Huber Needle Set) and a predicate device (Luther Safety Huber Needle Set, K021565). This is the "study" that proves the device meets the "acceptance criteria" of being equally safe and effective as the predicate. The document, by its nature, does not contain the detailed study methodologies, performance metrics, sample sizes, or ground truth establishment typically found in a clinical or performance study report for diagnostic or complex AI devices.

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