(115 days)
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PW Doppler, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) and Combined mode: B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B.
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic 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, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) 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.
This document is a 510(k) summary for the Mindray DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System, dated November 2, 2020. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific performance criteria through detailed studies as would be seen in a de novo submission or a PMA.
Therefore, the information regarding acceptance criteria and the study that proves the device meets them mainly revolves around regulatory compliance and comparison to already cleared devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the typical sense for a new AI/software feature. Instead, the acceptance criteria are implicit in the comparison to predicate devices and adherence to recognized standards. The "performance" is stated as being "similar" or "same" as the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary Indication for Use (Fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, and urology exams, and general purpose diagnostic ultrasound for imaging, measurement, display and analysis of human body and fluid) | "DC-30/DC-32/DC-28/DC-26/DC-26/DC-20/DC-30 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PW Doppler, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) and Combined mode…" (Page 4) |
| Similarity: "Subject device ... has the similar intended uses with the predicated device DC-30 (K173369)." (Page 6) | |
| Acoustic Power Levels (Below FDA limits) | "The acoustic power levels of DC-30/DC-32/DC-26/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp are below the limits of FDA, which is the same as the predicated device DC-30 (K173369)." (Page 7) |
| Electrical and Physical Safety Standards (Compliance with FDA recognized standards) | "DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-30 (K173369)." (Page 8) |
| (Specific standards listed on Pages 8-9) | |
| Features and Probes (Performance, functions, and safety similar to predicate devices) | "The added probes and Needle-guided brackets… are similar to the predicate device Z60 (K200411) and DC-40 (K183377)." (Page 7) |
| "The added features… has the same performance and functions with the predicated device Z60 (K200411) and DC-40 (K183377)." (Page 7) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "8. Clinical Tests: Not Applicable." (Page 9) This indicates that no clinical "test set" in the context of human data was used to demonstrate the performance of the new features or the overall device for substantial equivalence. The evaluation relies on non-clinical tests and comparisons to predicate devices.
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)
Since no clinical tests were performed, there are no details provided on experts or ground truth establishment from clinical data. The "ground truth" for compliance testing is against the established specifications and performance of the predicate device and recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no 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. The document specifically states "Clinical Tests: Not Applicable," and this ultrasound system is being cleared based on substantial equivalence to existing devices, not as an AI-assisted diagnostic tool requiring MRMC studies to demonstrate human reader improvement. The "Smart" features mentioned (i.e., Smart Face, Smart NT, Smart OB) are likely automated measurement or optimization tools rather than advanced AI diagnostic algorithms requiring such studies for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical studies are mentioned. The "standalone" performance testing for this type of device would typically involve technical and safety checks against industry standards, not a diagnostic accuracy assessment divorced from clinical use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests and comparisons to predicate devices, the "ground truth" is established by:
- Compliance with recognized industry standards: e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1, IEC 62366-1, IEC 60601-1-6.
- Established performance and specifications of the predicate devices: The functionality, acoustic output, and safety profile of the cleared predicate devices (Mindray DC-30, DC-40, Z60) serve as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. The document does not describe any machine learning/AI models that would require a dedicated "training set" to establish substantial equivalence for this device. The "Smart" features are presented as extensions or improvements consistent with existing device capabilities, not as entirely new, data-trained diagnostic algorithms.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned for AI/machine learning model development.
§ 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.