(43 days)
The DC-T6 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 cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.
DC-T6 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, CW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D 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 with a frequency range of approximately 2.5 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Mindray DC-T6 Diagnostic Ultrasound System. It details the device's classification, description, intended use, and comparison to predicate devices, along with non-clinical tests conducted. However, this document does not contain information about clinical acceptance criteria or a study that proves the device meets specific performance metrics.
The document does include "Diagnostic Ultrasound Indications for Use Form" for various transducers. These forms list the clinical applications for which each transducer is indicated (e.g., Fetal, Abdominal, Cardiac Adult) and the modes of operation available for those applications (e.g., B-Mode, M-Mode, Color Doppler). The 'P' next to many applications indicates "previously cleared by FDA," and 'N' indicates a "new indication." While this specifies what the device can be used for, it does not provide quantitative performance metrics or acceptance criteria for those uses, nor does it describe a study demonstrating such performance.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.
Here's a breakdown of the specific points you requested and why the information isn't available:
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A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Indications for Use" but does not define acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance results from a clinical study.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. The document primarily focuses on regulatory classification and substantial equivalence to predicate devices, along with non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.). No clinical study details (test set size, data provenance) are provided.
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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 mentioned. As no clinical study is detailed, there's no information about ground truth establishment or the experts involved.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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 mentioned. The device is a "Diagnostic Ultrasound System," not explicitly an AI-assisted device, and no MRMC study is detailed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
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The sample size for the training set: Not mentioned.
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How the ground truth for the training set was established: Not mentioned.
The document states that "DC-T6 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." This refers to non-clinical technical evaluations rather than clinical performance studies against specific acceptance criteria. The clearance is based on substantial equivalence to predicate devices, implying that its performance is considered comparable to already approved devices without needing a new, extensive clinical performance study to establish new clinical performance criteria.
§ 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.