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The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

Intended Use: Diagnostic ultrasound imaging and visualization of vessels for vascular access guidance of needles and catheters as follows: Peripheral vascular

The Sonic Window with the addition of software to perform and display ultrasound fluid flow analysis is a fully integrated handheld ultrasound imaging system that displays real-time ultrasound images on a coronal plane at a constant depth from the transducer. The depth is controllable by the operator. The Sonic Window system consists of the Sonic Window handheld device, the Docking Station/Charger and the AC Adapter. The Sonic Window uses an imaging mode, C-Mode, which provides the visualization in the coronal plane of peripheral vessels and assessment of vessels width and depth for needle/catheter placement.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria or detail a specific performance study with measured results for the "Sonic Window" device. It generally states that "predetermined acceptance criteria was met" without specifying what those criteria were or the achieved performance values.

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

The document does not provide any information regarding the sample size used for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective). The studies mentioned are "Performance, verification and validation testing" without specific details about patient data.

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

The document does not provide any information about the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it provide any effect size for human readers improving with AI vs. without AI assistance. The device description mentions a "C-Mode" for visualization and assessment but doesn't describe AI assistance for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

The document focuses on the device as an imaging system for "visualization of vessels and vascular access guidance." It does not describe a standalone algorithm performance without human-in-the-loop. The system displays images for an operator to use.

7. The Type of Ground Truth Used:

The document does not specify the type of ground truth used. It mentions design validation testing and performance testing but not the method for establishing ground truth for evaluating the device's accuracy in visualizing vessels or guiding access.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. The device is described as an ultrasound imaging system, and the submission is a "Special 510(k) Device Modification" which implies changes to an existing device rather than the development of a de novo AI algorithm with specific training data.

9. How the Ground Truth for the Training Set was Established:

As no training set is described, the document does not provide any information on how ground truth for a training set was established.

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The Sonic Window is intended for the visualization of vasular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

The Sonic Window is a fully integrated handheld ultrasound imaging system that combines electronics, transducer, display and battery into the same device. The device is designed and optimized to visualize real-time ultrasound images on a Coronal (Constant Imaging Depth) plane positioned at a distance (depth) from the transducer that is controllable by the user.

The Sonic Window device is an integrated handheld ultrasound imaging system designed for the visualization of peripheral vessels and assessment of vessel width and depth for needle/catheter placement. It is intended for use by medical professionals via prescription.

There is no study described that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy for its intended clinical use. The document primarily focuses on non-clinical testing for safety and technical equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and safety tests, not a clinical test set with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as part of the described non-clinical testing.
3. Adjudication method for the test set: Not applicable. No clinical test set.
4. 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 device is an ultrasound system, not an AI-assisted diagnostic tool as described in this document.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
6. The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering and safety standards (e.g., maximum permissible acoustic output, compliance with IEC standards for electrical safety and EMC, mechanical and environmental endurance specifications).
7. The sample size for the training set: Not applicable. This document does not describe machine learning or AI components requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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