The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S is a 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, THI, iScape,4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging 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 2.0 MHz to 10.0 MHz.
This document describes the premarket notification (510(k)) for the Mindray DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System. It is a submission to the FDA for substantial equivalence to legally marketed predicate devices.
The information provided focuses on the technical specifications, intended uses, and compliance with safety standards, rather than a study proving the device meets specific acceptance criteria related to AI performance or diagnostic accuracy in the way described in the prompt's request. Crucially, the document explicitly states that no clinical studies were performed.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain data on AI performance, human reader improvement with AI assistance, or specific acceptance criteria met through clinical trials. It primarily addresses the substantial equivalence of an ultrasound imaging system in terms of its features, safety, and technological characteristics compared to predicate devices.
However, I can extract the information relevant to the device's stated performance and the basis for its acceptance from a regulatory perspective, focusing on the equivalence to existing devices and compliance with safety standards.
Here's an attempt to answer using the provided text, while noting the limitations:
Acceptance Criteria and Device Performance (based on provided text):
The document does not define specific "acceptance criteria" for diagnostic accuracy or AI performance in the traditional sense, nor does it report "device performance" in terms of metrics like sensitivity, specificity, or AUC, as it's a 510(k) submission primarily focused on substantial equivalence (safety and efficacy similar to existing devices). Instead, the acceptance is based on demonstrating the device's technical characteristics, safety, and intended uses are comparable to already cleared predicate devices and comply with relevant standards.
Table of "Acceptance Criteria" (interpreted as demonstrated compliance/equivalence) and "Reported Device Performance" (interpreted as features/capabilities):
| Acceptance Criteria (from a regulatory perspective for 510(k)) | Reported Device "Performance" / Characteristics |
|---|---|
| Intended Use Equivalence: Device intended uses are substantially equivalent to legally marketed predicate devices. | The DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients, and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, Trans-esoph (Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exams. This is stated to be the same as the predicate device DC-70 (K150204). (Minor differences in specific transducer indications are noted but cleared based on "P=previously cleared by FDA" or "N=new indication" status, implying equivalence or new but standard indications supported by other predicate devices). |
| Acoustic Power Levels: Acoustic output levels are within FDA limits and comparable to predicates. | The acoustic power levels of the subject device are below the limits of FDA, and are the same as the predicate device DC-70 (K150204). |
| Electrical and Physical Safety: Device complies with recognized safety standards. | The device is designed in compliance with the FDA recognized electrical and physical safety standard, and is the same as the predicate device DC-70 (K150204). It has been tested and evaluated under standards including AAMI/ANSI ES60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, and ISO 10993-1. |
| Mechanical Safety & Biocompatibility: Device features are safe for use. | Evaluated for biocompatibility, cleaning and disinfection effectiveness, and mechanical safety. (Specific results are not detailed but compliance to standards like ISO 10993-1 is stated). |
| Technological Characteristics Equivalence: Key features and operating modes are comparable to predicates. | The system is a 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, THI, iScape, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging, or combined modes (i.e., B/M-Mode, B/PW-mode, B/PW/Color). It is a Track 3 device employing array probes with a frequency range of approximately 2.0 MHz to 10.0 MHz. New features include Contrast Imaging, Smart FLC, and Tissue Tracking Elastography. It has similar probes as the predicated device. |
| Quality System Compliance: Manufacturing processes adhere to quality standards. | The design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
Study Details (based on provided text):
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Sample size used for the test set and the data provenance: Not applicable. The document explicitly states "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." The evaluation relies on non-clinical (engineering, safety, and performance) testing and comparison to predicate devices, not diagnostic performance on a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies or test sets with ground truth were used or are described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies or test sets were used.
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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 document is for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Diagnosis) device providing analytical results that would assist human readers in a diagnostic task. The "Smart3D" and "iScape" features mentioned are imaging modes/enhancements, not necessarily AI for diagnostic assistance. There is no mention of such a study or effect size.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI diagnostic algorithm; it's an ultrasound imaging device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies or test sets for diagnostic accuracy were performed or are detailed.
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The sample size for the training set: Not applicable. This is not an AI/ML device that underwent training on a dataset for a diagnostic task.
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How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence to existing, legally marketed ultrasound devices through non-clinical testing (e.g., electrical safety, acoustic output, biocompatibility, software validation) and detailed comparison of technological characteristics and intended uses. It does not involve AI performance evaluation or clinical studies that would generate data for the specific "acceptance criteria" and "study proving device meets acceptance criteria" as outlined in your prompt for AI/diagnostic accuracy studies.
§ 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.