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The A.V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only.

Device Description

A.V. Fistula Needle Set is a single-use fistula needle which is inserted for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device consists of a needle that is attached to wings, a flexible tube and a luer lock connector.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "A.V. Fistula Needle Set for Single Use." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria for a novel AI or diagnostic device.

Therefore, the information required to populate the fields regarding acceptance criteria, study design details, ground truth establishment, sample sizes, and expert qualifications for a diagnostic device is not present in this document.

The document describes performance data for the A.V. Fistula Needle Set, but these are related to biocompatibility and sterilization tests for a physical medical device, not performance metrics for an AI/diagnostic algorithm.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility:
ASTM F750-87: Standard practice for evaluating material extracts by systemic injection in the mouse	Completed
ISO 10993-1: Biological evaluation of medical devices, Part 11. Tests for System Toxicity	Completed
ISO 10993-4: Biological evaluation of medical devices, Part 1. Evaluation and testing with a risk management process	Completed
ISO 10993-5: Biological evaluation of medical devices, Part 5. Tests for in vitro cytotoxicity	Completed
ISO 10993-7: Biological evaluation of medical devices, Part 7. Ethylene oxide sterilization residuals	Completed
ISO 10993-10: Biological evaluation of medical devices, Part 10. Tests for Irritation & sensitization	Completed
ISO 10993-11: Biological evaluation of medical devices, Part 11. Tests for System Toxicity	Completed
Sterilization:
ISO 11135-1: Sterilization of health care Ethylene oxide, Part 1. validation and routine control of a sterilization process	Completed
Mechanical Performance:
Tensile Force Test	Completed and compared to the predicate device.

Note: The document states these tests were "completed" but does not provide specific quantitative results or defined acceptance thresholds for these tests beyond general compliance with the standards.

Missing Information (Not Applicable to this type of device and submission):

Sample sizes used for the test set and the data provenance: Not applicable. This document refers to physical device testing, not a test set for an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. There is no AI training set.
How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" for this device consists of a series of standard performance tests and biocompatibility evaluations required for medical devices. The document implies that the device successfully passed these tests, thereby demonstrating its safety and effectiveness for its intended use and substantial equivalence to the predicate device. The tests, as listed above, cover:

Biocompatibility: Evaluating the material extracts, system toxicity, cytotoxicity, irritation, sensitization, and residuals from ethylene oxide sterilization. These tests ensure the device materials are safe for contact with the human body during temporary cannulation.
Sterilization: Validation and routine control of the ethylene oxide sterilization process to ensure the device is sterile for single use.
Mechanical Performance: A "Tensile Force Test" was conducted, and its results were compared to the predicate device to ensure similar mechanical properties.

The document states that a "claim of substantial equivalence is made to JMS North America Corp. A.V. Fistula Needle Set for Single Use (K990470)" and that "Bench testing was conducted to verify that the APLAN A.V. Fistula Needle Set for Single Use performs as well as the predicate device, thus concluding they are substantially equivalent." This indicates that the predicate device serves as the benchmark for acceptable performance, and the tests performed aimed to demonstrate that the new device performs equivalently.

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