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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 arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Note: The document states that these tests were "performed to demonstrate substantial equivalence," implying that the device met the requirements for each criterion to establish equivalence with predicate devices. However, specific quantitative acceptance thresholds or detailed performance results (e.g., exact deactivation force values, tensile strength measures) are not provided in the summary.

Study that proves the device meets the acceptance criteria:

The study refers to a set of "Performance Tests" conducted by Arrow International, Inc. These tests are listed as:

• Device reliability
• Clinical simulation
• Deactivation force of safety feature
• Safeguard interference fit
• Tensile
• Corrosion

The document does not provide the following information:

1. 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 explicitly stated. The nature of the tests (e.g., "clinical simulation") suggests some form of testing, but details on the participants or data collection are absent.
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, as this device is a medical instrument (catheterization set) and not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here would pertain to the physical performance of the device against engineering and safety specifications.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of performance tests described. Adjudication methods are typically used in clinical trials involving subjective assessments or diagnostic interpretations.
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 medical instrument, not an AI diagnostic or assistance tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device would be engineering specifications, safety standards, and functional requirements for a radial artery catheterization set, including regulatory safety features for needle protection.
7. The sample size for the training set: Not applicable. This device is a physical medical instrument and does not involve AI/machine learning models that require a training set.
8. How the ground truth for the training set was established: Not applicable.

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