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The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediativ, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel , intraoperative(abdominal, thoracic, and vascular) and urology exams.

Z6 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array.

This document is a 510(k) premarket notification for the Z6 Diagnostic Ultrasound System, which is a general-purpose ultrasonic diagnostic system. The document states that the device is substantially equivalent to legally marketed predicate devices and does not require clinical studies to support substantial equivalence. Therefore, the information typically associated with acceptance criteria and studies proving the device meets these criteria for a novel AI-driven medical device, such as detailed performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, are not explicitly provided or applicable in the context of this specific 510(k) submission.

This 510(k) is primarily focused on demonstrating "substantial equivalence" to existing, legally marketed ultrasound devices (predicates). This means the device is shown to have the same intended use, similar technological characteristics, and be as safe and effective as a predicate device. The performance validation relies on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.) and comparisons to previously cleared devices rather than new clinical efficacy studies.

Based on the provided text, here's what can be extracted regarding the device's validation and "acceptance criteria" in the context of a 510(k):

Acceptance Criteria (Implied by 510(k) Process for Substantial Equivalence):

The acceptance criteria for a 510(k) submission that relies on substantial equivalence are not explicit quantitative performance metrics like those for a novel AI algorithm. Instead, they are met by demonstrating that the new device:

• Has the same intended use as a predicate device.
• Has the same technological characteristics as a predicate device, or if it has different technological characteristics, that those differences do not raise new questions of safety or effectiveness AND the device is as safe and effective as the predicate device.
• Complies with applicable recognized safety standards.

The "Study" Proving the Device Meets Accepted Criteria (as described in the 510(k)):

The "study" here is the overall premarket notification submission process, which includes non-clinical testing and a detailed comparison to predicate devices, rather than a single clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for substantial equivalence and not a De Novo or PMA for a novel AI, there isn't a table of specific performance acceptance criteria like sensitivity, specificity, or AUC for an AI. Instead, the "performance" is demonstrated through adherence to safety standards and equivalence to predicate devices across various modes and applications.

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

• Sample Size: Not applicable in the context of this 510(k). The regulatory pathway for this device (a general-purpose ultrasound system with additional features found in other cleared devices) does not typically require a "test set" of patient data for performance evaluation in the same manner a novel AI algorithm would. Instead, substantial equivalence is primarily demonstrated through non-clinical testing and comparison to existing, cleared devices.
• Data Provenance: Not applicable, as patient data test sets are not described. The validation is based on engineering testing and comparison to predicate device specifications.

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

• Not applicable. There is no mention of a formal "ground truth" establishment by experts using a test set of patient data for the Z6 Diagnostic Ultrasound System in this 510(k). The submission focuses on device specifications, safety standards, and equivalence to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

• No. This 510(k) does not describe an MRMC study. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool in the manner that would typically necessitate such a study (e.g., for an AI CAD system). The "AI" features mentioned (Smart3D, iNeedle, etc.) are likely integrated functionalities that enhance image acquisition or guidance, not interpretative AI requiring MRMC.

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

• Not applicable for the overall device. The device is an ultrasound system with integrated features. While some features (like "Smart3D" or "iNeedle") might involve internal algorithms, their performance is demonstrated as part of the overall device's functionality and comparison to similar features in predicate devices, not as standalone AI outputs that require independent assessment against a ground truth.

7. The Type of Ground Truth Used:

• Not explicitly defined as a "ground truth" for clinical performance. For a traditional ultrasound system seeking 510(k) clearance via substantial equivalence, the "ground truth" for regulatory purposes often refers to established engineering standards, existing predicate device performance, and the inherent safety/efficacy of ultrasound technology itself, rather than a clinical dataset with adjudicated diagnoses.

8. The Sample Size for the Training Set:

• Not applicable. This submission is for a diagnostic ultrasound system, not a machine learning model developed with a training set of patient data and medical images.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As there is no mention of a training set for an AI model, there is no ground truth establishment for it.

In summary: This 510(k) submission for the Z6 Diagnostic Ultrasound System relies on demonstrating substantial equivalence to existing, legally marketed ultrasound devices. It does so by showing that the device has the same intended use, comparable technological characteristics (with new features demonstrated as equivalent to those found in other cleared predicate devices), and complies with relevant safety and performance standards through non-clinical testing. It does not involve the type of clinical performance studies, test sets, or AI model validation methods typically associated with novel AI-driven devices seeking a different regulatory pathway or greater emphasis on clinical efficacy.

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The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic. trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial). cardiac(adult, pediatric), peripheral vessel and urology exams.

Z6 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Power/Dirpower Mode, or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

The provided 510(k) summary for the Mindray Z6 Diagnostic Ultrasound System (K122010), like many ultrasound 510(k)s, describes safety and performance evaluations based on adherence to recognized medical safety standards and comparison to predicate devices, rather than a clinical study with specific acceptance criteria and performance metrics typically associated with AI/CADe devices.

In the context of this traditional ultrasound device, the "acceptance criteria" are the conformance with established safety and performance standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests and technical documentations submitted to the FDA for demonstrating substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not present (which is typical for this class and type of device submission):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Z6 Diagnostic Ultrasound System (Implied by FDA Standards and Predicate Comparison)

• IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-1 (General requirements for safety - Collateral standard: Safety requirements for medical electrical systems)
• IEC 60601-1-2 (General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)
• IEC 60601-1-4 (General requirements for safety - Collateral standard: Programmable electrical medical systems)
• IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)
• IEC 62304 (Medical device software - Software life cycle processes)
• IEC 62366 (Medical devices - Application of usability engineering to medical devices)
• UL 60601-1 (Medical electrical equipment, Part 1: General requirements for safety)
• ISO 14971 (Medical devices - Application of risk management to medical devices)
• ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) |
  | Acoustic Output | Evaluation performed. Conformed with applicable standards. |
  | Biocompatibility | Evaluation performed. Conformed with applicable standards. |
  | Cleaning and Disinfection Effectiveness | Evaluation performed. Conformed with applicable standards. |
  | Thermal, Electrical, and Mechanical Safety | Evaluation performed. Conformed with applicable standards. |
  | Intended Use Equivalence | Same intended uses as predicate devices (fetal, abdominal, intraoperative, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, urology exams). |
  | Technological Characteristics & Operating Modes Equivalence | Similar technological characteristics, comparable in key safety and effectiveness features, and same basic operating modes (B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Power/Dirpower Mode, or combined modes) as predicate devices. |
  | Quality System Compliance | Design, development, and quality process conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |

Reported Device Performance

The submission does not contain specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study for diagnostic efficacy. Instead, the "performance" is demonstrated by the device's adherence to the above-listed safety and performance standards and its substantial equivalence to previously cleared predicate devices in terms of intended use, technological characteristics, and basic operating modes. The FDA's clearance implies that the device's performance is deemed acceptable for its intended use based on these non-clinical evaluations and comparisons.

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/Not provided. This submission relies on non-clinical engineering tests and comparative analysis with predicate devices, not a clinical test set of patient data with performance metrics.
• Data Provenance: Not applicable/Not provided for a clinical test set. The non-clinical tests would have been performed at the manufacturer's facilities or certified testing laboratories.

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)

• Not applicable/Not provided. Clinical "ground truth" and expert review are not part of this type of 510(k) submission, which focuses on engineering safety and performance standards and substantial equivalence through non-clinical testing.

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

• Not applicable/Not provided. There was no clinical test set requiring adjudication.

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 device is a general diagnostic ultrasound system, not an AI/CADe device. No MRMC study was performed or required for this type of submission.

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

• Not applicable. This device is a diagnostic ultrasound system and does not involve AI algorithms operating in a standalone mode.

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

• Not applicable. As there was no clinical study evaluating diagnostic performance, no clinical "ground truth" was established in the context of this submission. The "ground truth" for the non-clinical tests would be the established specifications and parameters for the various electrical, mechanical, thermal, and acoustic performance aspects outlined in the relevant IEC/UL/ISO standards.

8. The sample size for the training set

• Not applicable. This device is a diagnostic ultrasound system, not an AI/Machine Learning product that would require a "training set" of data.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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