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The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "SonixGPS Nerve Block Needle Kit." This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report.

The letter primarily confirms that the device has been found substantially equivalent to predicate devices and outlines regulatory compliance requirements. It details the device's name, regulation class, product code, and indications for use.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target. The needle sensor consists of a sensor head, cable and a connector.

Here's an analysis of the acceptance criteria and study information for the SonixGPS™ Needle Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria for System Accuracy:

The document states, "The subject devices met the same defined accuracy criteria as the predicate device," and "[The SonixGPS™] demonstrated equivalent performance which met the defined criteria." While the specific numerical accuracy criteria for the predicate are not detailed in this 510(k) summary, the core acceptance criterion for the SonixGPS™ Needle Sensor was to achieve performance equivalent to the predicate device (K092619) under its established accuracy protocol.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of tests, number of measurements, number of devices tested) for the performance "System Accuracy" testing. It only mentions that the "performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "System Accuracy" test appears to be a technical or engineering performance test against a defined protocol, rather than a clinical study requiring expert interpretation or ground truth establishment in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable as the "System Accuracy" test described is a technical performance assessment, not a study involving human readers or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study described is a technical performance test comparing the new device against a predicate device's existing performance standards.

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

This document describes a standalone performance test of the device itself (the needle sensor), not an algorithm. The accuracy test described is for the device's ability to track position, which is an inherent function of the device, not an "algorithm only" performance separate from its intended use. While it's a "device only" test, the term "standalone" as typically used in AI/software refers to algorithmic performance without human intervention, which isn't directly applicable here as it's a physical device.

7. The Type of Ground Truth Used

For the "System Accuracy" test, the ground truth would be established by the needle sensor accuracy performance protocol and the Sonix 3D Motion Tracking (SonixGPS™) Verification Protocol and Report. This implies a defined, objective standard or known positions against which the device's tracking accuracy was measured. It's a technical ground truth rather than a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The SonixGPS™ Needle Sensor is an electromagnetic tracking hardware device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there is no training set for this type of device.

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The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.

The SonixGPS™ Vascular Access Needle Kit includes: Vascular Access Needle: Disposable sterile vascular access needle Sensor Introducer: Disposable sterile sensor introducer into which the needle sensor (K111818) is inserted Cover: Disposable sterile cover provides a barrier to prevent transfer of microorganisms, body fluids and' particulate material to the reusable component.

The SonixGPS™ Vascular Access Needle Kit underwent performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document details performance testing for various aspects (biocompatibility, sterilization, packaging, mechanical) but does not specify the exact sample sizes for each test in the provided text. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond "Animal performance testing was conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the specific performance tests listed. These tests are primarily laboratory and standardized evaluations against pre-defined criteria.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it applies to human interpretation or decision-making on a test set. The performance tests are objective evaluations against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned in the provided text. The device is a physical medical kit (needle, sensor introducer, cover), not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The performance testing listed (biocompatibility, LAL, packaging, sterilization, mechanical) can be considered "standalone" in that they evaluate the device itself against established criteria, without requiring human interaction or interpretation beyond conducting the test and recording results. However, the animal performance testing was conducted to demonstrate the combined function of the SonixGPS™ Vascular Access Needle Kit with the Sonix Ultrasound Scanners and SonixGPS™ Needle Sensor. This implies an evaluation of the system as a whole, rather than the needle kit in strict isolation, in a functional setting.

7. Type of Ground Truth Used

For the various performance tests (biocompatibility, sterilization, packaging, mechanical), the ground truth is established by the specified international standards and guidelines (e.g., ISO, ASTM, USP, FDA guidelines). For the "Animal performance testing," the ground truth was the observable function of the device in assisting vessel cannulation without impairing the function or raising new safety/effectiveness concerns.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or machine learning. The device is a physical medical device kit and not an AI or software product that would typically undergo training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

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