The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/Transcrania; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superticial); 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.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the ZS3 and z.one pro Ultrasound Systems.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ZS3 and z.one pro Ultrasound Systems are primarily defined by their adherence to various medical safety standards and their demonstrated substantial equivalence to previously cleared predicate devices. The reported device performance is based on successful compliance with these standards and the equivalence established through non-clinical testing.
Here's a breakdown of the acceptance criteria (standards met) and reported performance (compliance):
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards: | |
| - AAMI/ANSI ES60601-1 (Basic safety and essential performance) | ZS3 and z.one pro Ultrasound Systems conform to this standard for electrical and physical safety. |
| - IEC 60601-1-2 (Electromagnetic compatibility) | ZS3 and z.one pro Ultrasound Systems conform to this standard. |
| - IEC 60601-2-37 (Ultrasonic medical diagnostic and monitoring equipment) | ZS3 and z.one pro Ultrasound Systems conform to this standard for basic safety and essential performance of ultrasonic equipment. |
| - ISO 10993-1 (Biological evaluation of medical devices) | Patient contact materials of new added transducers and needle-guided bracket are tested under and conform to this standard. |
| - Acoustic output levels below FDA limits (UD 2, UD 3) | The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, which are the same as the predicate device ZS3 and z.one pro (K151175). Real-time display of thermal and mechanical acoustic output indices is compliant. |
| Software Standards: | |
| - IEC 62304 (Medical device software life cycle processes) | The design, development, and quality processes confirm with the requirements of this standard. |
| Risk Management Standards: | |
| - ISO14971 (Application of risk management to medical devices) | The design, development, and quality processes confirm with the requirements of this standard. |
| Functional Equivalence: | |
| - Same intended use as predicate device (K151175) | The subject device has the same intended use as the predicate device ZS3/z.one pro (K151175), covering a broad range of clinical applications (Ophthalmic, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac), Musculoskeletal, Cardiac Adult/Pediatric, Intra-cardiac, Peripheral vessel). |
| - Same basic operating modes as predicate devices | The modified ZS3 and z.one pro have the same imaging modes (e.g., B, M, PWD, CWD, Color Doppler, Combined Modes) as the predicate devices. |
| - New added features are same as predicate devices | Specific new features (ARFI, CEUS for Liver, CEUS for LVO, Smart OB, Smart NT, Auto EF, Auto IMT, Stress Echo, Anatomical M, Needle-Guided bracket NGB-022) were compared to predicates. |
| - Similar transducers with predicate devices | The modified ZS3 and z.one pro have similar transducers as the predicate devices. |
| Quality Systems: | |
| - 21 CFR 820, ISO 9001, and ISO 13485 quality systems | The design, development, and quality process of the manufacturer conforms with these quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" sample size or data provenance in the context of a clinical study or performance evaluation for the modified ZS3 and z.one pro Ultrasound Systems. The submission relies heavily on non-clinical tests to demonstrate substantial equivalence to previously cleared predicate devices.
The document states:
- "Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Refer to the table above for listed standards).
- "The subject device has the same intended use as the predicated device ZS3/z.one pro(K151175)"
- "The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, which are the same as the predicated device ZS3 and z.one pro (K151175)."
- "The modified ZS3 and z.one pro are designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device ZS3 and z.one pro (K151175)."
This indicates that the assessment is based on a comparison to established performance and safety profiles of predicate devices and compliance with technical standards, rather than a new clinical study with a specific test cohort of patients. Therefore, there is no direct information on test set sample size or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no dedicated clinical test set is described in the submission as a primary means of demonstrating performance, there is no information provided regarding a number of experts or their qualifications for establishing ground truth. The submission relies on technical compliance and equivalence to predicate devices, which would have undergone clinical validation previously.
4. Adjudication Method for the Test Set
As there is no described clinical test set, there is no information on any adjudication method used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document explicitly states: "Clinical Tests: Not Applicable." This indicates that no MRMC comparative effectiveness study, or any clinical study comparing human readers with and without AI assistance, was performed or presented in this submission.
6. Standalone (Algorithm Only) Performance Study
The document does not describe any standalone performance study of an algorithm without human interaction. The focus is on the ultrasound system and its various features/modes, not a specific AI algorithm delivering a diagnostic output that would require a standalone performance evaluation.
7. Type of Ground Truth Used
Given that the submission primarily relies on non-clinical testing and comparison to predicate devices for substantial equivalence, the "ground truth" implicitly refers to:
- Engineering specifications and measurements: For acoustic output, electrical safety, thermal performance, etc.
- Biological evaluation standards: For biocompatibility of materials (ISO 10993-1).
- Established performance of predicate devices: The functionality and clinical utility are considered equivalent to those of previously cleared devices, which would have undergone their own validation processes (likely clinical studies or expert consensus during their initial clearance).
There is no specific mention of "expert consensus," "pathology," or "outcomes data" as directly used to establish ground truth for this particular submission's performance claim, as it's a modification and comparison to already cleared devices.
8. Sample Size for the Training Set
Since this submission pertains to the modification and substantial equivalence of ultrasound systems and does not describe the development of a specific AI algorithm with a training phase, there is no information on a "training set" sample size. The "new added features" like ARFI and CEUS are functional modalities, not necessarily AI algorithms that require a distinct training set in the way a diagnostic AI would.
- Note: If "Smart" features (e.g., Smart OB, Smart NT, Auto EF, Auto IMT) involve AI, the document does not disclose their development or training data.
9. How the Ground Truth for the Training Set was Established
As no training set is described in the context of an AI algorithm, this information is not applicable and not provided in the document.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.