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The intended uses of this system and its accessories are as follows: Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

The devices referenced in this submission represent a highly portable, softwarecontrolled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes or deviations from indications for use different from those demonstrated in previously cleared devices, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 4 (±12%) MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8.0 (±20%) MHz; A probe EC, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8,0 (±20%) MHz. Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.

The provided document describes a 510(k) submission for the Ardent Sound Voyager Compact Imaging System, specifically regarding the addition of M-Mode capabilities and an Endocavity probe.

Based on the content, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards rather than establishing new performance acceptance criteria for a novel device. The "acceptance criteria" presented are fundamentally about meeting established safety and performance benchmarks for diagnostic ultrasound systems as defined by regulatory standards and existing cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5." This indicates that no clinical test set (i.e., patient data) was used for this submission. The "testing" primarily involved engineering and performance verification against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set or human interpretation ground truth was established for this submission. The submission relies on technical compliance and equivalence to predicate devices, which would have had their own ground truth establishment studies during their original clearances.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. This submission is for a diagnostic ultrasound system and its probes, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the technical performance of the device (acoustic output, biocompatibility, cleaning):

• Acoustic Output: Measured values against industry standards (AIUM, NEMA, IEC).
• Biocompatibility: Lab testing results against ISO 10993-1.
• Cleaning/Disinfection: Verification against established effectiveness protocols.

For the substantial equivalence claim regarding clinical utility:

• Predicate devices: The "ground truth" for the clinical effectiveness and safety of the intended uses (B-mode, M-mode, specific applications like fetal, abdominal, etc., and needle guidance) is based on the prior clearance of the predicate ultrasound systems. The submission asserts that the new device's intended uses and operating modes are "available in the predicative devices."

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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