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The SonicEye® ultrasound transducer is a general-purpose transducer intended for use by a qualified clinician for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following applications: Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (conventional and superficial), and Peripheral Vessel.

The SonicEye® is a finger-mounted ultrasound transducer designed to attach to the SonoSite MicroMaxx® ultrasound system, in place of the SonoSite SLA/13-6 transducer, to acquire ultrasound images for display on the system. The SonicEye® transducer connects to the MicroMaxx® system's standard transducer port. Upon connection, the visual display on the MicroMaxx® system denotes that a type "SLA" transducer is in operation. The SonicEye® acoustic array is located in a small ring structure worn on the user's finger. The array is a linear type, with a 5-12 MHz frequency range, average scan depth of 3 cm and maximum scan depth of 6 cm. The array contains 128 elements spaced at 200 micron pitch, forming an azimuthal total aperture size of 25.6 mm. The elevational aperture height is 4 mm. The array supports acquisition of ultrasound images in 2D, M-Mode, Pulsed Wave (PW) Doppler, and Color Power Doppler, or in a combination of these modes.

This document describes a 510(k) premarket notification for the "SonicEye® Ultrasound Transducer" by Blacktoe Medical III, Inc. The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, the SonoSite SLA/13-6 Transducer for MicroMaxx® high-resolution ultrasound system (K053069).

The acceptance criteria and study information provided in this document are focused on demonstrating that the SonicEye® transducer is safe and effective when compared to the predicate device, primarily through safety testing and comparison testing with the predicate probe, rather than a clinical study measuring diagnostic accuracy against a specific ground truth.

Here's an breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an ultrasound transducer, the "acceptance criteria" are related to safety and "performance" refers to image quality and functionality being equivalent to the predicate. The document doesn't explicitly list numerical acceptance criteria in terms of diagnostic metrics (e.g., sensitivity, specificity) for a particular disease. Instead, it asserts equivalence in general safety and image quality.

Study Proving Acceptance Criteria:

The document explicitly states: "Safety testing of the SonicEye® and comparison testing with the predicate probe show no differences in safety or image quality that would impact the effectiveness of the device." This is the core 'study' described for demonstrating equivalence for safety and image quality. It is a direct comparison between the subject device and the predicate device.

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

The document does not specify a sample size for a test set in the context of diagnostic performance (e.g., number of patients, images). The "comparison testing" mentioned for image quality and safety is likely an engineering/benchtop comparison rather than a clinical study involving human subjects or a dataset of images with established ground truth diagnoses.

Data Provenance: Not applicable as it's not a clinical diagnostic study with patient data. The comparison testing would likely involve physical measurements and potentially phantom imaging.

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

This information is not provided and is likely not relevant to this type of submission. As it's an ultrasound transducer, the "ground truth" for its performance typically refers to physical specifications, image quality metrics (e.g., resolution, penetration, contrast), and safety parameters, which are assessed through engineering tests and comparison to a predicate, not by expert diagnostic consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as there is no clinical diagnostic test set requiring human interpretation.

5. 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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This device is an ultrasound transducer, a hardware component, not an AI software algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. This is a hardware device.

7. The Type of Ground Truth Used

For the "comparison testing" regarding image quality and safety, the ground truth would be established by:

• Physical measurements and engineering specifications: For safety (acoustic output, electrical safety, biological compatibility per referenced standards) and fundamental image quality parameters (e.g., spatial resolution, contrast resolution, penetration, sensitivity), often assessed using phantoms.
• Direct comparison to the predicate device: The predicate device itself, having already been cleared by the FDA, serves as the de facto "ground truth" for acceptable performance. The aim is to demonstrate that the SonicEye® performs "no different" from the predicate.

8. The Sample Size for the Training Set

Not applicable. This submission is for a hardware device, an ultrasound transducer. There is no mention of an algorithm or a training set for machine learning.

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

Not applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.

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