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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.

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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.

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The device is 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-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Echo, Intra-Cardiac; Pelvic: Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity, Vet and others as stated in 1.3.

The ZONARE ZS3 is a general purpose diagnostic ultrasound system which consists of a the previous cleared portable scanner integrated into the ZONARE z.one Ultra Smartcart to enable the user to focus on performing patient scans with a more streamline unit. No longer convertible, the ZONARE ZS3 will still be considered a mobile system as it will be lightweight and easy to move from room to room. The new system, which uses the same software base as the currently approved z.one Ultra ultrasound system, will have . hardware changes which are minimal, but require some redesign in the cart base in order to put working components of the scanner inside the cart. Otherwise, the user interface and other features/functionalities of the system are substantially equivalent to the ZONARE Ultra Ultrasound System in both indications for use and system functionality. The new ZS3 will be based on the ZONARE's patented zone sonography, and with the scanner's internal components now inside the cart base, the ZS3, without compromising safety and effectiveness, should improve image quality through a higher signal to noise ratio, as well as support a wider range of future enhancements. Features, such as multi transducer ports will be standard in the system as will an embedded hard drive and DVD. The system with the ZONARE Ultra current suite of transducers. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy. There is no difference between the currently cleared ZONARE transducers (K101091) and the transducers as shown in this submission for the ZS3. The system provides holders for transducer models, and will be offered with battery chargers and other accessories. The modification for this submission includes no new indication for use but does have 1 transducer the C10-3 added as appendix E to the ZONARE z.one Ultra Ultrasound system which will be declared new to this system.

The provided document describes a 510(k) premarket notification for the ZONARE ZS3 Ultrasound System. This submission asserts substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria, device performance, or a study designed to prove the device meets performance criteria in the way a clinical trial for a novel device would.

Instead, the document focuses on:

• Predicate Device Comparison: Demonstrating that the ZONARE ZS3 is substantially equivalent to currently marketed ZONARE z.one Ultra Ultrasound System (K082326, K101091) and other predicate devices in terms of features, functionality, indications for use, safety, effectiveness, software, materials, and design/construction.
• Non-clinical tests: Compliance with applicable medical device quality systems and safety standards (e.g., ISO 14971, IEC/UL 60601-1, IEC 62304, ISO 10993, AIUM Medical Ultrasound Safety).
• Indications for Use: Listing the various clinical applications and modes of operation for the system and its associated transducers. The document distinguishes between "new" (N) indications for the system (which usually refers to the C10-3 transducer being new to this specific system, but its indications are compared against existing ones) versus "previously cleared by FDA 510(k)" (P) for other transducers, implying that the performance for these previously cleared indications was established by prior submissions.

Based on the provided text, a conventional "acceptance criteria" table and a "study proving the device meets the acceptance criteria" as requested does not exist in the typical sense for a clinical performance study. The submission relies on demonstrating substantial equivalence to a predicate device, which usually means showing that the new device is as safe and effective as the predicate without necessarily conducting new clinical efficacy studies.

Specifically, the document states: "Clinical Tests: Not Required". This is a key piece of information.

Therefore, many of the requested fields cannot be directly answered from the provided text, as the regulatory pathway chosen (510(k)) and the nature of the submission (substantial equivalence to a predicate device with minimal hardware changes and the same software) did not necessitate the types of studies that would generate such data.

Here's how to address the request based on the available information:

1. A table of acceptance criteria and the reported device performance

As "Clinical Tests: Not Required" is stated, there are no specific clinical acceptance criteria or reported device performance metrics from a dedicated clinical study for this 510(k) submission. The acceptance criteria for substantial equivalence are that the device is as safe and effective as legally marketed predicate devices. The "performance" is implicitly demonstrated through compliance with non-clinical safety standards and the established performance of the predicate device with which it shares key components and software.

• ISO 14971 (Risk Management)
• IEC/UL 60601-1 (Electrical Safety)
• IEC 60601-1-1 (Systems Safety)
• IEC 60601-1-2 (EMC)
• IEC 60601-1-4 (Programmable Medical Systems)
• IEC 60601-2-37 (Ultrasonic Diagnostic Safety)
• IEC 62304 (Software Life Cycle)
• ISO 10993 (Biocompatibility)
• AIUM Medical Ultrasound Safety
• Verification and Validation
• Cleaning and Disinfection effectiveness
• Thermal, Electrical, and Mechanical safety, Acoustic output | "The device has been evaluated according to the applicable medical device quality systems, safety standards...", and "The device conforms to applicable medical device safety standards and compliance for safety and effectiveness which is verified through defined verification and validation, and market surveillance." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. Clinical tests were not required, and no test set was used for a clinical performance study.
• Data Provenance: Not applicable, as no new clinical data was generated for this substantial equivalence submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. Clinical tests were not required.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing enhanced interpretation.
• Effect Size of Human Reader Improvement with AI: Not applicable.

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

• Standalone Performance Study: No, this is not an algorithm-only device. It's an ultrasound imaging system that requires human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable. Clinical tests were not required. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate ZONARE z.one Ultra Ultrasound System.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning device that typically involves a training set for model development in the context of a clinical performance study. The "training" for the system's underlying software would have occurred for the predicate device.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable.

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