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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/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-recinal, Trans-cranial, Trans-sophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adultí Pediativ Fetal; Echo, Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

The ZS3 and z.onewo Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) 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 platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

This document describes the ZONARE Medical Systems, Inc. ZS3 and z.onepro Ultrasound Systems, which were submitted for 510(k) premarket notification (K151175). The submission primarily concerns adding new patient contacting materials to the E9-4 transducer and expanding the indications for use for one transducer (C9-3sp), stating that the core system and other transducers remain unchanged from a previous clearance (K150249).

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the acceptance criteria are based on compliance with various safety and performance standards for ultrasound systems and the equivalence to a previously cleared predicate device. The reported device performance is presented as "PASS" for all tested categories.

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

The document does not explicitly mention a "test set" in the context of a clinical study with a specific sample size. The testing performed is described as "Non-Clinical Testing" and focuses on engineering and regulatory compliance rather than clinical performance evaluation on a patient population.

The data provenance is from non-clinical testing performed by ZONARE Medical Systems, Inc. It is not clinical data and therefore not categorized as retrospective or prospective in the traditional sense of patient studies.

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

This information is not applicable to the provided document. The submission concerns technical and safety compliance of an ultrasound system, not the performance of an algorithm that relies on expert interpretation to establish a ground truth for a test set. There were no "experts" establishing ground truth in the context of clinical device performance for this specific submission as no clinical studies were deemed necessary.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring adjudication by experts 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

This information is not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool described in the typical sense of MRMC studies. The document does not mention any AI components or comparative effectiveness studies of human readers with or without AI assistance.

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

This information is not applicable. The device is an ultrasound system, not an algorithm, and no standalone algorithm performance is discussed.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/CAD performance evaluations is not directly applicable here. The "truth" for the non-clinical tests is established by adherence to recognized electrical, mechanical, thermal, acoustic, biocompatibility, and software standards, as well as the stated device performance specifications.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device and therefore no training set was used.

In summary, this document is a 510(k) premarket notification for an ultrasound system, primarily focusing on modifications that maintain substantial equivalence to an already cleared device. The "studies" are non-clinical engineering and regulatory compliance tests, not clinical performance studies involving patient data or AI algorithms.

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