(16 days)
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.
The DC-7 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, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI 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 probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.
The provided text is a 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing devices and details the device's features, intended use, and safety considerations. It does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or accuracy for diagnostic tasks.
Instead, the document primarily addresses:
- Manufacturing and Safety Standards: The device conforms to acoustic output standards (NEMA UD 2:2004, NEMA UD 3:2004) and medical device safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1). These are the "acceptance criteria" for the safety and basic functionality of the ultrasound system itself, not for a specific diagnostic performance.
- Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is the demonstration that the DC-7 is "as safe and effective as the legally marketed predicate devices" (Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688)). This is not a study measuring diagnostic accuracy but rather a comparison of technical characteristics and intended uses.
Therefore, many of the requested details about a performance study are not present in this type of regulatory submission. I will answer the questions based on the information available and explicitly state when information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system and not a specific diagnostic algorithm or AI, the "acceptance criteria" are related to safety, electrical, and acoustic performance, and functional equivalence to predicate devices, rather than diagnostic accuracy metrics. The document states that the device was tested to meet recognized international and national standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantially equivalent to legally marketed predicate devices. | "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." This is a general claim based on the entire submission, including comparisons of various characteristics (technical characteristics, new features/algorithms, and indications for use) to predicate devices. The listed predicate devices are: Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688). |
| Acoustic Output | Conforms to FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008), NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, and NEMA UD 3:2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. | "The acoustic output is measured and calculated per NEMA UD 2: 2004 (...) and NEMA UD 3: 2004 (...). The device conforms to applicable medical device safety standards..." |
| Medical Device Safety | Conforms to applicable medical device safety standards. | "The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1." |
| Functional Equivalence/Modes | The device should be capable of acquiring and displaying ultrasound images in specified modes (B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI mode, combined modes) and for the stated clinical applications with the listed transducers. | The comprehensive "Indications for Use" forms for the system and each transducer (pages 5-23 of the original document) list the specific modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) and clinical applications (e.g., Fetal, Abdominal, Cardiac, Small organ, Peripheral Vascular, etc.) for which the system and its associated transducers are intended and found to be substantially equivalent to predicate devices. |
Regarding diagnostic performance studies, the document contains no information on the following points:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No details on a specific diagnostic performance test set are provided. The "testing" mentioned refers to safety and functional compliance, and comparison to predicate devices, not clinical diagnostic accuracy of an algorithm.
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 as no diagnostic performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no diagnostic performance study is described.
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-purpose ultrasound system, not an AI-powered diagnostic algorithm or an assist tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable as no diagnostic performance study is described.
8. The sample size for the training set
Not applicable. This device is a general-purpose ultrasound system. Any "new algorithm" mentioned in section 3 (page 1) would likely refer to internal signal processing or imaging algorithms, not a machine learning model trained on a large dataset for diagnostic output. No details about such training are provided.
9. How the ground truth for the training set was established
Not applicable as no training set for a diagnostic algorithm is mentioned.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.