(59 days)
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-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) 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, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Reape View, TDI, Color M. Strain Elastography, Contrast imaging (Contrast imaging (Contrast agent for LVO), STE,STQ.
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array. convex array, pencil phased and phased array.
The provided text is a 510(k) Summary for a Diagnostic Ultrasound System, which is a general-purpose diagnostic imaging device. For such devices, the FDA typically relies on non-clinical performance data (e.g., electrical safety, acoustic output, electromagnetic compatibility, software validation) to demonstrate substantial equivalence to a predicate device, rather than clinical studies with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity.
Therefore, the document explicitly states: "8. Clinical Tests: Not Applicable."
This means that the type of study for proving the device meets acceptance criteria, in the context of diagnostic performance metrics, was not performed for this submission. The "acceptance criteria" discussed in the document are primarily related to safety, electrical performance, and adherence to recognized standards, rather than clinical diagnostic efficacy.
Given the information in the provided document, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
As clinical tests were "Not Applicable" and no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device's efficacy, a table of diagnostic acceptance criteria and performance cannot be generated from the provided text.
However, the document lists compliance with various regulatory and safety standards, which can be seen as the "acceptance criteria" the device met for its substantial equivalence determination. The "reported device performance" is its demonstration of compliance with these standards and its similarity to the predicate device.
| Acceptance Criteria (Safety & Performance Standards) | Reported Device Performance |
|---|---|
| - AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). |
- IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes.
- ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
- NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
- IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety.
- The device was found to conform with applicable medical safety standards (listed above).
- The acoustic power levels are below FDA limits, similar to the predicate device.
- The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device.
- The device's safety and effectiveness profile is found to be similar to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for diagnostic performance as no clinical tests were performed.
- Data Provenance: Not applicable for diagnostic performance. For safety and performance evaluations, the data would typically come from internal engineering and lab testing conducted by the manufacturer (Shenzhen Mindray Bio-Medical Electronics Co., LTD in China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical tests or diagnostic performance evaluations requiring expert ground truth were conducted or reported in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable as no clinical tests or diagnostic performance evaluations requiring adjudication were conducted or reported in this 510(k) summary.
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
- No MRMC comparative effectiveness study was done or reported. This device is a general diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study for 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a diagnostic ultrasound system, not an standalone algorithm. The device has "Smart" features (e.g., Smart 3D, Smart Planes FH, Smart Pelvic, iClear+), but these are integrated functionalities of the ultrasound system itself, not standalone algorithms requiring separate "algorithm-only" performance evaluation in the context of this 510(k). The regulatory pathway for this device does not necessitate such a study as it's a general-purpose ultrasound.
7. The type of ground truth used
- Not applicable for diagnostic performance metrics, as no clinical efficacy studies were conducted. For the non-clinical tests, the "ground truth" would be the established specifications and limits defined by the international and national standards to which the device was tested for compliance.
8. The sample size for the training set
- Not applicable. This document describes a traditional diagnostic ultrasound system. While it has "Smart" features that likely involve internal algorithms some of which might be trained, the document does not provide details on algorithm training, or a "training set" in the context of a machine learning model submitted for software as a medical device (SaMD) clearance.
9. How the ground truth for the training set was established
- Not applicable, as a training set for a machine learning model is not discussed or required for this type of 510(k) submission for a general diagnostic ultrasound system.
§ 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.