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Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.

With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:

· Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) · Modes of Operation: B-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M. and B+CD. B+PW. B+CW. and Harmonic Imaging

Kosmos is intended to be used in clinical care and medical education settings on adult and pediations.

The device is non-invasive, reusable, and intended to be used on one patient at a time.

Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2).

The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only).

The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.

Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for:

• patient data archival,
• updating the embedded Kosmos Software (Kosmos Bridge configurations only), or ●
• downloading or updating the Kosmos Software Application from the Google Play Store ● (Kosmos On Android configuration only)

Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner.

Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.

The provided document is a 510(k) Premarket Notification for the EchoNous Kosmos device. It specifically states that "An assessment of clinical performance data for Kosmos was not required to support a determination of substantial equivalence."

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria from a clinical perspective. It only reports compliance with non-clinical performance standards.

As requested, I will provide the information that is available in the document, acknowledging the absence of clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance criteria are provided, this table will reflect compliance with non-clinical performance standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for clinical data. The document focuses on compliance with non-clinical performance standards. For these standards, "All verification and validation testing" was conducted, implying that the device itself underwent testing to confirm its specifications were met, rather than using a separate "test set" of clinical data.
• Data Provenance: Not applicable for clinical data. The focus is on the device's adherence to engineering and safety standards.

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

Not applicable, as no clinical test set with ground truth established by experts is described for this submission. The "ground truth" for the non-clinical tests would be the specifications outlined in the various standards.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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

The document explicitly states: "Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature."

Therefore, no MRMC comparative effectiveness study was done for AI-assisted features for this 510(k) submission, as these features were not part of the current clearance.

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

This document does not describe standalone algorithm performance studies for The Kosmos device. The mention of "AI-assisted EF Workflow and Trio tool" indicates potential future AI capabilities, but these are specifically noted as "not yet cleared by the FDA" in this submission.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" is implied to be the requirements and specifications within the listed FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2). The device's performance was evaluated against these established benchmarks.

8. The sample size for the training set

Not applicable. This document is a 510(k) for a diagnostic ultrasound system and its integrated components, focusing on substantial equivalence to predicate devices and compliance with non-clinical performance standards. It does not describe the development or training of AI algorithms.

9. How the ground truth for the training set was established

Not applicable, as no AI training set is described in this submission.

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