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The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.

The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.

The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).

The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.

The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.

The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.

The system is a transportable ultrasound system intended for use in environments where healthcare is provided.

The EdgeLife Handheld Wireless Ultrasound System consists of:

• EdgeLife Handheld Ultrasound Scanner:
  • o Model E8200 with convex and linear transducers
  • o Model E8220 with convex and endocavitary transducers
• EdgeLife Ultrasound App .
• Standard off-the-shelf Wireless Qi charger (not a medical device) ●

The provided text is a 510(k) summary for the EdgeLife Handheld Wireless Ultrasound System (models E8200 and E8220). This document describes the device, its intended use, and a comparison to a predicate device, along with non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria related to its human-in-the-loop performance or algorithm-only performance for diagnostic tasks, as would be expected for a device incorporating AI for clinical decision support. Instead, the document focuses on the hardware and basic functional safety and effectiveness of the ultrasound system itself.

Therefore, many of the requested items (e.g., expert ground truth, adjudication, MRMC studies, effect size of AI assistance, standalone algorithm performance, training set details) are not present in the provided text. The document primarily describes the device's technical specifications and compliance with general medical device standards.

Here's a breakdown of what information is available based on the provided text, and what is missing:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing to support the substantial equivalence of the device to its predicate. These are predominantly engineering and safety acceptance criteria, not diagnostic performance criteria for an AI or imaging algorithm.

Table of Acceptance Criteria (from Non-Clinical Performance Testing):

Study Details (based on available information):

1. Sample sizes used for the test set and the data provenance:

   • The document mentions "internal test methods" for measurement accuracy but does not provide specific sample sizes (e.g., number of measurements, phantoms, or clinical cases) or data provenance (country of origin, retrospective/prospective).
   • No clinical study with a "test set" in the context of diagnostic accuracy for an AI component is described. The "performance data" mentioned refers to non-clinical verification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as no diagnostic performance study involving expert ground truth is described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable.

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:

   • No MRMC study or any study involving human readers with AI assistance is mentioned. The device is described as an "ultrasonic diagnostic system" to acquire and display data, not one with AI-driven diagnostic assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No standalone algorithm performance study is mentioned. The device is an ultrasound system, not an AI diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable, as no diagnostic performance validation is described. The "ground truth" for the non-clinical tests would be defined by the standards and phantoms used (e.g., known dimensions for measurement accuracy).

7. The sample size for the training set:

   • Not applicable, as no AI model requiring a training set is described within the scope of this FDA submission summary. The software validation is generic.

8. How the ground truth for the training set was established:

   • Not applicable.

Conclusion based on the provided text:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the EdgeLife Handheld Wireless Ultrasound System to a predicate device based on its technical specifications, intended use, and compliance with general medical device safety and performance standards (biocompatibility, electrical safety, EMC, acoustic output, cleaning/disinfection, and basic software/measurement validation). It does not describe any AI-related diagnostic function or a clinical study that evaluates the improvement of human readers with AI assistance, or the performance of an AI algorithm in a standalone capacity. Therefore, the specific criteria and study details requested for AI-driven devices are not present in this document.

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