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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:

1. 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.

2. 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.

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 mentioned. As no clinical study is detailed, there's no information about ground truth establishment or the experts involved.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. The device is a "Diagnostic Ultrasound System," not explicitly an AI-assisted device, and no MRMC study is detailed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.

8. The sample size for the training set: Not mentioned.

9. 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.

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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 vascular and urology exams.

DC-T6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-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, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

The provided 510(k) summary for the DC-T6 Diagnostic Ultrasound System is primarily a declaration of substantial equivalence to predicate devices and outlines the device's technical specifications, intended uses, and compliance with various safety standards. It does not contain information on specific acceptance criteria for diagnostic performance, nor does it detail a study proving the device meets such criteria.

The document focusses on:

• Device Description: General purpose, mobile, software-controlled ultrasound system with various imaging modes (B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode).
• Intended Use: Broad range of clinical applications across different patient populations (adults, pregnant women, pediatric, neonates) and anatomical regions.
• Comparison with Predicate Devices: Lists several Mindray and GE ultrasound systems, stating that the DC-T6 has similar technological characteristics, safety/effectiveness features, and intended uses.
• Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning/disinfection, and thermal/electrical/mechanical safety, conforming to applicable medical safety standards.
• Conclusion: Asserts substantial equivalence based on consistent intended uses with traditional clinical practices and FDA guidelines, and adherence to quality systems (21 CFR 820, ISO 9001, ISO 13485).

Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets those criteria, as such information is not present.

The document is a regulatory submission for premarket notification (510(k)), which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical performance studies with specific acceptance criteria like those for novel AI/diagnostic software. For a traditional ultrasound system, the "performance" demonstrated for 510(k) clearance typically involves meeting technical specifications (e.g., image quality, acoustic output limits, safety standards) and proving it is as safe and effective as a predicate device for its intended uses.

The information requested in points 1-9 (acceptance criteria table, sample size, expert ground truth, etc.) is characteristic of a clinical validation study, often required for more novel or complex devices, especially those incorporating AI, to demonstrate specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). This level of detail is not typically included in a 510(k) summary for a general diagnostic ultrasound system that relies on substantial equivalence to well-established technology.

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