Search Results

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.

Ask a specific question about this device

The ZS3 and z.onepro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obsteric, gynccological; Abdominal (renal, GYN/Pelvic; Intracter and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc.), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Peripheral vascular; hamonic tissue and contrast imaging and Tissue elasticity.

The ZS3 and z.one, 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ZS3 and z.onepro Ultrasound Systems.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the typical sense of a diagnostic algorithm. Therefore, many of the requested items related to AI/algorithm performance (like effect size, training set details, ground truth for training) are not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the ZS3 and z.onepro Ultrasound Systems are based on compliance with various safety and performance standards for diagnostic ultrasound systems, as well as demonstrating substantial equivalence to predicate devices (ZONARE's ZS3 Ultrasound System K120703 and ZONARE's z.one ultra Ultrasound System K101091).

The "reported device performance" in this context refers to the outcomes of the non-clinical testing performed to show compliance with these standards and specifications.

Study Details (Non-Clinical Testing for Substantial Equivalence)

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical testing which typically does not involve a "test set" of patient data in the same way an AI algorithm study would. Instead, it involves testing the hardware and software against engineering specifications and regulatory standards.
   • No specific sample sizes for image data or patient cases are mentioned, as this is not a clinical performance study. The "test set" consists of the physical device components and software.
   • Data provenance: N/A for this type of non-clinical testing. The "testing" is conducted on the manufactured device itself or its components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable (N/A). The "ground truth" for non-clinical engineering and regulatory compliance testing is established by the specifications and standards themselves, not by expert interpretation of medical images. For example, the ground truth for "Electrical Safety" is whether the device meets the specified limits in IEC 60601-1, which is measured by test equipment, not human experts.

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

   • N/A. Adjudication methods are relevant for studies involving human interpretation where consensus is needed to establish ground truth for medical conditions. This document details engineering compliance testing.

4. 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:

   • No MRMC study was done. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. There is no mention of AI assistance for human readers.

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

   • No standalone algorithm performance was done in the context of diagnostic interpretation. This is a medical imaging device, not a standalone AI diagnostic algorithm.

6. The type of ground truth used:

   • For the non-clinical testing, the "ground truth" is defined by established engineering standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993) and the device's internal performance specifications. For instance, the ground truth for "Acoustic Output" is the maximum derated ISPTA and Mechanical Index values allowed by the standard, and the device is tested to ensure it operates within these limits.

7. The sample size for the training set:

   • N/A. This is a hardware and software system, not an AI/machine learning model that requires a "training set" of data in the common sense. The software validation refers to standard software development lifecycle testing, not AI model training.

8. How the ground truth for the training set was established:

   • N/A, as there is no "training set" in the context of AI.

Summary of the Study:

The "study" described in the provided document is a comprehensive set of non-clinical, engineering, and regulatory compliance tests. The purpose of these tests is to demonstrate that the ZS3 and z.onepro Ultrasound Systems meet all applicable safety, electrical, mechanical, and performance standards for diagnostic ultrasound devices. This type of submission (510(k)) relies heavily on showing that the new device is "substantially equivalent" to predicate devices already cleared for market, meaning it operates in a similar way, has similar intended uses and indications for use, and meets the same safety and effectiveness standards, without raising new questions of safety or effectiveness. No clinical efficacy studies or AI-related performance metrics are presented or required for this type of device clearance.

Ask a specific question about this device