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The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial.

The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Imagio Ultrasound Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has a PW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear scanning modes, and supports linear array probes.

The Imagio Ultrasound Imaging System is comprised of the following subsystems provided by Analogic Corporation, (previously Ultrasonix), and used in common with the predicate device:

• Modulo - ultrasound acquisition subsystem:
  • ultrasound transmit and receive electronics;
  • transducer interface connection to transducer accessory;
  • computer control, image formation, and image processing;
• control console;
• clinical display;
• L14-5/38 transducer;
• ultrasound imaging software;

The above subsystems from the predicate device are incorporated in the Imagio Ultrasound Imaging System together with the following Seno Medical designed components: Cart Mechanical Design

• frame;
• casters;
• wheel locking;
• adjustable height mounting arm for console and display;
• cart electrical;
  • electrical wiring and optical cables;
  • power distribution unit;
• enclosures;
• USB alpha-numeric keyboard assembly.

Note that the Analogic software has been modified to remove support for applications and transducers not needed by Seno Medical customers.

The provided document, a 510(k) Premarket Notification for the Imagio® Ultrasound Imaging System (K182628), states that clinical testing was NOT required to support substantial equivalence due to the device utilizing the same technology and principles as an existing predicate device (Sonix MDP Ultrasound Scanner, K080935).

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as a specific clinical study for this device's performance was explicitly deemed unnecessary for its clearance.

In summary, based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided/Not applicable as no clinical study was conducted.
• 2. Sample sized used for the test set and the data provenance: Not applicable.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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, an MRMC study was not done. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of image interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The clearance was based on substantial equivalence to a predicate device already cleared by the FDA, relying on the fact that "Diagnostic ultrasound and imaging has a long history of safe and effective performance" and the technical specifications and safety standards compliance of the Imagio system itself. The document, however, does provide "Acoustic Output Limits" that the device must conform to for safety, which could be considered a form of acceptance criteria:

Acoustic Output Limits (Acceptance Criteria Mentioned for Safety)

The document states, "The devices acoustic output limits are: *The limits are the same as predicate Track 3 devices." This implies the Imagio system meets these limits, but no specific performance data for these parameters from a study within this document is presented. Rather, compliance with these limits and other safety standards (e.g., electrical, EMC, biocompatibility) was "verified through independent evaluation with ongoing manufacturer surveillance."

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