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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.

The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and receive ultrasound energy.

The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.

The provided document is a 510(k) premarket notification for the ZONARE z.one Ultra Ultrasound System. This type of submission is for demonstrating substantial equivalence to legally marketed predicate devices, not for proving the device meets acceptance criteria through clinical studies in the same way a new, high-risk device might.

The document explicitly states: "Clinical Tests: Non Required" and then elaborates: "ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that the ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market."

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted from this document, as such studies were not required for this type of submission. The "acceptance criteria" here largely refer to the device's ability to perform its intended functions similarly to predicate devices and adherence to safety standards.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since formal clinical studies with specific performance metrics are not required and therefore not reported in this 510(k), I can only infer the "acceptance criteria" as meeting the general capabilities and safety standards demonstrated by predicate devices.

Each table indicates whether an application is a "P" (previously cleared by FDA 510k # 022858, implying equivalence to the existing ZONARE z.one) or "N" (new indication). For "P" indications, the device is considered to perform equivalently to the predicate. For "N" indications, the device is being introduced for those uses, likely based on similarity to other cleared devices or demonstrating safety and basic functionality in non-clinical tests.

Examples of supported modes for various transducers include:

• B¹ (B-Mode and Harmonic Imaging): P (Previously cleared) or E (Added under Appendix E) or N (New indication) across most applications.
• M (M-Mode): P or E or N across most applications.
• PWD² (Pulsed Wave Doppler and HPRF): P or E or N across most applications.
• CWD (Continuous Wave Doppler): P or N for specific applications (e.g., Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult & Pediatric, Peripheral Vascular for the main system, and specific entries for some transducers).
• Color Doppler³ (Color Doppler, Directional Power Doppler, Power Doppler): P or E or N across most applications.
• Combined Modes⁴: P or E or N across most applications.
• Other⁵,⁸ (e.g., Color M-Mode, Freehand tissue elasticity): P or E or N for relevant applications.

The presence of "P" or "E" in these tables fundamentally means that for those indications and modes, the ZONARE z.one Ultra performs equivalently to the already cleared ZONARE z.one (K022858) or other cleared predicate devices. The "N" indications represent new proposed uses for the system or specific transducers, which are deemed safe and effective through substantial equivalence to other devices or non-clinical testing. |
| Safety and Effectiveness Standard Adherence: The device must conform to applicable medical device safety standards. | "The device has been evaluated according to the applicable medical device safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety."
"The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance."
"ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems." |
| Predicate Device Features Equivalence: The device must have the same important safety and effectiveness features, design, materials, and construction as predicate devices. | "Additionally, they [ZONARE z.one Ultra and predicate devices] have the same important safety and effectiveness features, as well as design, materials, and construction." |

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

• Sample Size for Test Set: Not applicable. No clinical test set (in the sense of patient data for performance evaluation) was specified as "Clinical Tests: Non Required."
• Data Provenance: Not applicable. No clinical data was used for a test set. The validation relies on substantial equivalence and adherence to safety standards.

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

• Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This document is for a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was conducted or required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This is not an algorithmic/AI device; it's a hardware system.

7. The Type of Ground Truth Used

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's safety and effectiveness is established by its substantial equivalence to legally marketed predicate devices and its compliance with recognized medical device safety standards. This is not a "ground truth" in the clinical data sense (e.g., pathology, outcomes data). The existing ZONARE z.one (K022858), GE Voluson i (K053435), Philips iU22 (K042540), and Siemens Acuson S2000 (K072786) served as predicates.

8. The Sample Size for the Training Set

• Not applicable. The device is a diagnostic ultrasound system, not an AI/machine learning model that typically undergoes a "training" phase with a dataset.

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

• Not applicable for the same reason as above.

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