(11 days)
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)
| Acceptance Criteria Category | Description (as per submission) |
|---|---|
| Safety Standards Conformance | Designed to meet and evaluated for conformance with: |
- 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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.