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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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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-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

The ZS3 and z.onews 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.

The exam dependent default settings for the ZS3 allows 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 Ultrasound Platform supports system integration to a variety of upgradable options and features. Up to three ZONARE transducers can be connected to the multi-transducer port permitting easy transducer transition. The ZS3 Ultrasound Platform can be operated on either battery or AC power.

This document describes the ZS3 and z.onepro Ultrasound Systems and their transducers, stating they are substantially equivalent to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI performance perspective, as it is a 510(k) submission for an ultrasound system, not an AI/ML device.

However, I can extract information related to the general device performance and testing completed to ensure its safety and effectiveness, which serves as a form of acceptance criteria for a medical device regulatory submission.

Here's a summary of the non-clinical testing performed for the ZS3 and z.onepro Ultrasound Systems, which implicitly demonstrates their compliance with established standards:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for an ultrasound system, the "acceptance criteria" are embodied by compliance with recognized medical device standards and the device performance specifications as demonstrated through non-clinical testing. The "device performance" refers to the system passing these tests.

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

This document describes non-clinical testing of a hardware and software system, not an AI/ML algorithm that processes a "test set" of patient data. Therefore, the concept of "sample size for the test set" and "data provenance" in the context of clinical data does not apply here. The testing was carried out through standard engineering and laboratory methods on the physical device and its software.

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

This is not applicable as the submission concerns a physical medical device (ultrasound system) and its compliance with engineering and safety standards, not the diagnostic accuracy of an AI algorithm evaluated against expert consensus. The "ground truth" for these tests are the established standards and specifications themselves.

4. Adjudication method for the test set:

Not applicable for a non-clinical device safety and performance evaluation.

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:

Not applicable. This is a submission for an ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

Not applicable as this is a medical device (ultrasound system) submission and not an AI algorithm.

7. The type of ground truth used:

For the non-clinical testing described, the "ground truth" is defined by:

• Engineering specifications and device performance requirements: These are internal standards set by the manufacturer for the device's functionality.
• International and national standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, and EN 62304.
• FDA Guidance Documents: For cleaning & disinfection and software validation.

8. The sample size for the training set:

Not applicable as this is not an AI/ML algorithm requiring a training set.

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

Not applicable as this is not an AI/ML algorithm requiring a training set.

In summary, this document relates to the regulatory clearance of an ultrasound imaging system as a medical device. The "acceptance criteria" are compliance with established safety, performance, and manufacturing standards, demonstrated through rigorous non-clinical engineering and biological testing. It does not pertain to the performance evaluation of an AI algorithm.

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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.

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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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-cranial, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) 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 both transmit 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 includes new indication for use and off the shelf transducers.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary and associated forms do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance metrics for the ZONARE z.one Ultra Ultrasound System.

Instead, the submission primarily focuses on functional equivalence and compliance with recognized standards for safety and effectiveness. The "acceptance criteria" for this type of submission are implicitly tied to demonstrating that the device is "substantially equivalent" to predicate devices and adheres to relevant safety and performance standards.

The "reported device performance" is essentially that the device (including its transducers and new indications for use) performs comparably to the predicate devices and meets established safety benchmarks.

Here's how we can represent the "acceptance criteria" and "reported device performance" based on the document:

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

The document explicitly states: "Clinical Tests: Not Required."

This indicates that no dedicated clinical test set (i.e., a set of patient data specifically collected for performance evaluation against a ground truth) was used in this 510(k) submission. The basis for safety and effectiveness is the substantial equivalence to previously cleared devices and compliance with non-clinical standards.

Therefore, information regarding data provenance (country of origin, retrospective/prospective) and sample size for a test set is not applicable to this submission.

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

Since no clinical tests or dedicated test sets were used, there were no experts required for establishing ground truth from such a set.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set was used.

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

Not applicable. This is a 510(k) submission for an ultrasound system, not an AI-powered diagnostic device. The application does not mention any AI components or MRMC studies.

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

Not applicable. This is a medical imaging system, not an algorithm being submitted for standalone performance evaluation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe the use of specific ground truth types (like pathology or outcomes data) in a clinical study context for this submission, as no clinical studies were deemed necessary. The ground truth for demonstrating safety and effectiveness relied on the established performance of the predicate devices and the compliance with engineering and safety standards.

8. The Sample Size for the Training Set

Not applicable. Given that "Clinical Tests" were "Not Required" and there's no mention of an algorithm or AI being developed, there would be no training set in the context of device performance evaluation. The device development process would have involved engineering testing and verification, but not "training data" in the sense of machine learning.

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

Not applicable, as no training set (for an algorithm/AI) was mentioned or used in this submission.

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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.

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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