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The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.

The Arrow Echogenic Introducer Needle has the following characteristics:
Outside Diameter = 18Ga - 21Ga
Inside Diameter = 0.0240 - 0.042 in.
Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)
Grit-blast echogenic surface treatment

Here's an analysis of the provided information regarding the Arrow Echogenic Introducer Needle, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Summary, does not explicitly list quantitative acceptance criteria in a pass/fail format. Instead, it describes performance tests undertaken to demonstrate substantial equivalence to predicate devices. The and the reported device performance are generally stated as achieving "substantial equivalence."

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

The document does not specify the sample size used for the "Needle penetration test" or "Hub bond tensile strength test." It only mentions that these "tests were performed."

Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests and not clinical studies.

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

This information is not applicable to the provided document. The studies performed are physical, bench-top performance tests of a medical device (needle penetration and hub bond tensile strength). These do not involve human interpretation or expert evaluation for establishing ground truth in the way, for example, a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the tests are physical performance tests, not studies requiring expert 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

This information is not applicable. The device is an echogenic introducer needle, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study assessing human reader improvement with AI assistance would not be relevant.

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 an algorithm.

7. The Type of Ground Truth Used

The ground truth for the "Needle penetration test" and "Hub bond tensile strength test" would have been established through objective, standardized measurements and criteria for defining "penetration" and "tensile strength" in a mechanical testing environment. These are typically based on engineering and material science principles, and reference standards for medical device testing. It is not based on expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical performance testing for a medical device like an introducer needle. Training sets are relevant for machine learning algorithms.

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

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

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The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire. A peripherally inserted central catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.

The Peripherally Inserted Central Catheter Kits contains many of the components required for the user to place the PICC. An introducer needle is used to gain access to the vein. A guidewire is then placed through the introducer to provide a track for the remaining devices. After removal of the introducer needle from the vein, the guide wire is left in place and a dilator/peel-away introducer assembly is advanced into the vessel thereby enlarging the subcutaneous track. When positioned, the dilator is removed and the peel-away introducer remains along with the guide wire. The PICC is placed through the introducer catheter. After catheter positioning is confirmed, the guide wire and peel-away introducer are removed. A "Stat-Lock" catheter fixation device secures the catheter during use.

The provided text describes a 510(k) summary for the Arrow Echogenic Introducer Needle, a component of Peripherally Inserted Central Catheter Sets. It includes information about the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria and a study report with performance metrics in numerical form as requested in the prompt.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the questions related to sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance. The document focuses on establishing substantial equivalence through a general statement of "Performance tests: Tests were performed to demonstrate substantial equivalence in the following areas: - Needle penetration - Hub bond tensile strength test" and a conclusion that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."

This type of submission typically relies on comparing the device's physical and functional characteristics to a legally marketed predicate device rather than presenting a detailed clinical study with numerical performance metrics against pre-defined acceptance criteria.

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