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The Arrow CVC have the following characteristics:
Radiopaque polyurethane catheters
16Ga, 1 Lumen
7Fr through 8.5Fr, 2 through 4-Lumens
Usable lengths of 16 - 20cm
Catheters are provided sterile kit configurations.
The catheter is labeled with the maximum flow rating on the catheter distal hub to facilitate the proper use of the device.

AI/ML Overview

The provided document describes a 510(k) summary for Arrow Central Venous Catheters. The focus of the submission is to expand the Indications for Use to include the "injection of contrast media" with power injectors. The document details non-clinical performance tests to demonstrate substantial equivalence for this expanded use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Non-clinical Performance
- Flow rate Qualification Test: Ensure catheter can achieve specified flow rates.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion for the specified flow rates, though specific rates are not listed here beyond the instruction "do not exceed the maximum labeled flow rate.")
- Repeat Injection Test: Demonstrate durability and integrity under repeated pressure injections.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion, though specific number of injections or integrity metrics are not detailed.)
- Catheter Burst Pressure Test: Verify the catheter's ability to withstand pressure without bursting.	"The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters." (Implied successful completion, though the specific burst pressure achieved is not detailed, only the instruction that "maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi." suggests the catheters are designed to withstand this or higher pressures.)
Clinical Performance (Feasibility, Safety, Efficacy for Power Injection)	"Two studies evaluated the feasibility, safety and efficacy of the use of the Arrow International's central venous catheters for the purpose of power injection of contrast media during diagnostic imaging procedures. Arrow International's Pressure Injectable CVC devices have been demonstrated to be safe and effective for the high pressure administration of contrast media when hospital guidelines and injection protocol are followed." (High-level statement of success. Specific metrics, patient outcomes, or detailed findings from these studies are not provided in this summary.)
Substantial Equivalence to Predicate Devices	"Arrow International's central venous catheter has the same intended use as the predicate devices. Based on the assessment of non-clinical and clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's central venous catheter is substantially equivalent to the legally marketed predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the non-clinical or clinical tests.
Data Provenance: Not specified. It only states "Two studies evaluated" for the clinical performance. The non-clinical tests are bench tests, so provenance is less relevant beyond being conducted by the manufacturer.

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 as the device is a physical medical device (catheter) and the studies described are performance tests and clinical feasibility/safety/efficacy studies, not diagnostic imaging studies requiring expert ground truth for interpretation.

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

This information is not applicable/provided. The studies mentioned are performance tests and clinical observations, not image interpretation requiring adjudication of ground truth.

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/provided. This document describes a physical medical device (catheter), not an AI diagnostic tool.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm.

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

For the non-clinical tests (Flow Rate, Repeat Injection, Catheter Burst Pressure): The "ground truth" would be the engineering specifications and recognized standards for catheter performance and safety. The tests directly measured physical properties against these predefined criteria.
For the clinical performance data: The "ground truth" would be patient safety, efficacy in delivering contrast media, and observation of adverse events or complications, as assessed in the "two studies." Specific outcomes data are not detailed in this summary.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This information is not applicable/provided. There is no "training set" for this device.

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