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The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

This document describes the 510(k) premarket notification for the ZS3 and z.one pro Ultrasound Systems. This is a notification of intent to market a medical device, asserting its substantial equivalence to previously cleared devices. Therefore, the information provided focuses on demonstrating this equivalence through non-clinical testing and comparison to predicates, rather than extensive clinical studies or formal acceptance criteria for an AI/CADe device.

Based on the provided information, the device is an ultrasound system and not an AI/CADe device. As such, the typical acceptance criteria and study design for AI/CADe devices (multireader multi-case studies, ground truth establishment by multiple experts, defined performance metrics like sensitivity/specificity, etc.) are not applicable to this submission.

The acceptance criteria here pertain to the ultrasound system's performance and safety standards, and the "study" proving acceptance is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an ultrasound system and not an AI/CADe device, the acceptance criteria are based on compliance with recognized safety and performance standards for ultrasound equipment. The "reported device performance" is implicitly that the device conforms to these standards.

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

This document describes a 510(k) submission for an ultrasound imaging system. As such, it does not involve a "test set" or "data provenance" in the sense of a machine learning model's evaluation data. Instead, validation is based on non-clinical tests (electrical safety, acoustic output, biocompatibility, etc.) performed on the physical device and its components, in accordance with recognized industry standards. The data provenance would be the results from these engineering and biological safety tests. The specific "sample size" of devices or components tested is not detailed in this summary but is generally part of standard engineering verification and validation.

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

Not applicable. This is not an AI/CADe device, and therefore, an expert-established "ground truth" for a diagnostic test set is not relevant to its 510(k) submission. The "ground truth" for a device like this is its adherence to safety and performance standards.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of diagnostic interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This is an ultrasound imaging system, not an AI/CADe device designed to assist human readers, so such a study is not relevant.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with established safety and performance standards for diagnostic ultrasound equipment, as detailed in section 7 ("Non-clinical Tests") of the 510(k) summary. This includes standards for electrical safety, acoustic output, biocompatibility, and software development, rather than clinical outcomes or expert consensus on image interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware/software medical device (ultrasound system), not an AI/CADe system that undergoes machine learning training with a specific "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this type of device. The specifications and performance are established through engineering design, quality control, and adherence to regulatory standards.

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