Search Results

The QuikTork guide wire torque device is intended to facilitate guide wire interventional procedures.

The QuikTork torque device is designed and intended to be used for the manipulation and placement of guide wires used during interventional procedures. The QuikTork device is not body contacting as the device is used by threading the guide wire end, which is outside the body, through the device lumen to provide an easier grip for manipulation of the guide wire. Once the guide wire is positioned, the QuikTork is removed. The device consists of one piece of molded polyoxymethylene, and is yellow or orange depending on the diameter of the guide wire that will be used with the device. The yellow device supports guide wire diameters 0.010 to 0.020 inches, and the orange device supports guide wire diameters 0.025 to 0.040 inches.

This document describes the QuikTork Torque Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification from the FDA for a medical device called the "QuikTork Torque Device," which is a manual tool used to manipulate guide wires in interventional procedures. It is not an AI-powered device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them, as the provided input does not describe an AI device or a study of its performance against acceptance criteria.

To answer your request, I would need a document that describes:

1. An AI-powered medical device.
2. Specific acceptance criteria for that AI device.
3. A study evaluating the performance of that AI device against those criteria, including details on sample size, data provenance, ground truth establishment, expert involvement, and study design (standalone vs. MRMC).

Ask a specific question about this device

The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

MARROWMAX Bone Marrow Aspiration Needle Kit

The provided document is a 510(k) clearance letter from the FDA for a bone marrow aspiration needle kit. It confirms substantial equivalence to a predicate device but does not contain any information about acceptance criteria, performance data, or studies that prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval for marketing the device.

Ask a specific question about this device

The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk.

The provided text is a 510(k) summary for a medical device called the "NeedleTech Guidewire Introducer Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving performance against acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document does not contain the specific information requested regarding acceptance criteria studies for AI/device performance. The 510(k) summary focuses on device description, intended use, and substantial equivalence to existing predicate devices.

Here's why the requested information isn't present and what information is provided:

1. Acceptance criteria and reported device performance (Table): This document does not describe specific performance testing against acceptance criteria in the way a clinical study for a novel device would. It relies on the predicate devices to establish safety and effectiveness.
2. Sample size, data provenance (test set): Not applicable for a 510(k) summary. No test set for performance evaluation against acceptance criteria is described.
3. Number of experts, qualifications (ground truth for test set): Not applicable. No ground truth adjudication for a test set is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This device is a physical introducer needle, not an AI or imaging diagnostic tool.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no AI component or "training set" for this physical device.
9. How ground truth for the training set was established: Not applicable.

What the document does provide in relation to regulatory acceptance:

• Device Name: NeedleTech Guidewire Introducer Needle
• Intended Use: The guidewire introducer needles are intended to be single-use disposable introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
• Predicate Devices: Terumo Neolus Needle, Medtronic Disposable Hypodermic Needle Electrode, MINIRAD Light Saber Introducer Needle, Manan Blunt Needle.
• Substantial Equivalence Statement: "The NeedleTech Guidewire Introducer Needle is substantially equivalent to a combination of its predicate devices, with the exception of minor differences in size and general indications for use, which raise no new issues regarding safety of effectiveness."
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.

In summary, this 510(k) document establishes the regulatory acceptance for the "NeedleTech Guidewire Introducer Needle" based on its substantial equivalence to predicate devices, rather than a detailed study proving performance against specific acceptance criteria for a novel device or AI application.

Ask a specific question about this device