(97 days)
The Z5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal (conventional, superficial), Peripheral Vascular, Trans-vaginal, Small organ (breast, thyroid and testes), Cephalic (neonatal and adult), Cardiac (adult and pediatric) and Urology exams.
Z5 is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power, HPRF, iScape, 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 with a frequency range of approximately 3.5 MHz to 10.0 MHz.
This submission is a 510(k) Pre-market Notification for the Z5 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria and a device performance study including sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in provided text.
Based on the provided information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capabilities. Instead, it relies on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be comparable and safe.
The "reported device performance" is implicitly that the device is "substantially equivalent" to the predicate devices and conforms to various safety standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety | Conformity with applicable medical safety standards: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, UL 60601-1, ISO14971, ISO 10993-1, IEC 62366, IEC 62304. | "Z.5 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards." |
| "The device conforms to applicable medical device safety standards." | ||
| Effectiveness/Equivalence | Same technological characteristics as predicate devices (Mindray Z6, M5, DP-30). | |
| Comparable in key safety and effectiveness features as predicate devices. | ||
| Same intended uses and basic operating modes as predicate devices. | "Z.5 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices: They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices." | |
| "Therefore, the Z5 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." | ||
| Quality System | Conformity with 21 CFR 820. ISO 9001 and ISO 13485 quality systems. | "The design, development and quality process of the manufacturer confirms with 21 CFR 820. ISO 9001 and ISO 13485 quality systems." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any information regarding a specific clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on non-clinical testing and comparison to predicate devices, not on a new clinical study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set is described, there is no information provided on the number or qualifications of experts used to establish ground truth.
4. Adjudication Method:
Given the absence of a described clinical test set, there is no information provided on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader, multi-case comparative effectiveness study or any effect size for human readers improving with AI assistance. The Z5 is a diagnostic ultrasound system, and the submission predates widespread AI integration in such devices for diagnostic assistance comparisons.
6. Standalone Performance Study:
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The Z5 is a complete ultrasound system, and its performance is inherently a human-in-the-loop process.
7. Type of Ground Truth Used:
No specific ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for the performance evaluation of the Z5 Diagnostic Ultrasound System. The evaluation is focused on technical standards compliance and substantial equivalence to previously cleared devices.
8. Sample Size for the Training Set:
The document does not mention a training set as it pertains to AI or machine learning algorithms. The Z5 is a traditional diagnostic ultrasound system.
9. How the Ground Truth for the Training Set was Established:
Since no training set for AI/ML is mentioned, there is no information provided on how ground truth for such a set would have been established.
In summary: The provided 510(k) summary focuses on the technical specifications, intended use, and comparison to predicate devices to establish substantial equivalence for the Z5 Diagnostic Ultrasound System. It is not a clinical study report that would typically detail performance against specific clinical acceptance criteria using patient data, expert ground truth, or statistical measures like those requested.
§ 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.