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The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.

The Guide Wire Torque Device is a guide wire accessory developed to assist in the manipulation and placement of hydrophilic and other typical guide wires during interventional procedures. It accomodates guide wires from .018 to .038 inches and is composed of three components: 1. An ABS plastic body; 2. A polypropylene "core" which grips the guide wire; and 3. A stainless steel spring which supplies the force to grip the guide wire.

The design of the Guide Wire Torque device allows single-handed operation. The wire gripping actuator is depressed while the guide wire is threaded through the device's lumen. When the Guide Wire Torque Device is located on the guide wire in the appropriate location, the actuator is released allallowing the device to grip the guide wire.

The provided text describes a medical device, the Guide Wire Torque Device, which is an accessory to assist in manipulating guide wires during interventional procedures. However, it does not contain any information regarding specific acceptance criteria, performance studies, or test results (such as accuracy, sensitivity, or specificity metrics) that would typically be found in a study proving a device meets acceptance criteria.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against predefined acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable for this type of mechanical device.
• The type of ground truth used: Not applicable for this type of mechanical device.
• The sample size for the training set: Not mentioned (and not applicable for this mechanical device).
• How the ground truth for the training set was established: Not mentioned (and not applicable).

The document states:
"Merit believes that the prior use of the component materials of the Guide Wire Torque Device in legally marketed devices, the performance data provided, and the biocompatibility data provided demonstrate that the Guide Wire Torque Device is substantially equivalent to the predicate device."

This indicates that some performance data was submitted, likely focusing on mechanical functionality, material safety (biocompatibility), and design similarity to the predicate device, rather than clinical performance metrics in the way you'd expect for an AI/software device. The summary itself does not elaborate on what that "performance data" entailed.

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DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc).

The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.

Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.

All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

The provided document is a 510(k) summary for the "DOLPHIN Inflation Device". It is a premarket notification for a medical device and describes its indications for use, technological characteristics, and how its substantial equivalence to predicate devices was demonstrated. However, this document does not contain acceptance criteria or detailed study data to prove device performance against such criteria in the way typically expected for an AI/ML device or a device requiring specific performance metrics like sensitivity/specificity for a diagnostic tool.

Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Indeflator 20/30) based on intended use, conditions of use, design, materials, packaging, sterilization, and location. The "Performance Data" section briefly states that "The safety and efficacy of DOLPHIN has been demonstrated through a variety of preclinical tests and analyses, as well as non-clinical comparisons to the Indeflator 20/30." It does not provide specific numerical acceptance criteria or detailed results of these tests.

Therefore, I cannot populate the requested table and answer the study-specific questions as the detailed information on acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML device are not present in this 510(k) summary.

The questions you've asked are typical for the evaluation of AI/ML-based diagnostic or prognostic devices, which often require extensive clinical performance studies with specific statistical endpoints. The "DOLPHIN Inflation Device" is a manual, mechanical device (an angiographic injector and syringe) used to inflate and deflate balloon catheters during cardiovascular procedures. Its evaluation for 510(k) clearance primarily focuses on demonstrating its functional equivalence and safety compared to existing devices, rather than establishing diagnostic accuracy metrics.

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