Search Results

The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic(neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.

DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).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 Mindray DC-N3/DC-N3S Diagnostic Ultrasound System does not include a study to prove acceptance criteria for device performance. Instead, it states that the system has been evaluated for various safety and performance aspects and found to conform with applicable medical safety standards, establishing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed device performance metrics in a tabular format for clinical efficacy. It only broadly states that the device conforms to various safety standards. Therefore, an acceptance criteria table from this document cannot be created as requested.

2. Sample Size Used for the Test Set and Data Provenance:

No specific clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described in relation to evaluating the performance of the device's diagnostic capabilities. The submission focuses on substantial equivalence based on technical characteristics and safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

As there is no described clinical efficacy study with a test set, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as no specific clinical test set and ground truth establishment process are detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention any MRMC comparative effectiveness study where human readers' improvement with AI vs. without AI assistance was evaluated. The device is a diagnostic ultrasound system, and the submission's focus is on its technical safety and equivalence rather than an AI-driven diagnostic aid.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No standalone (algorithm only) performance study is described. The device is a complete ultrasound system, not an algorithm being evaluated independently.

7. Type of Ground Truth Used:

No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as there is no detailed clinical efficacy study described for establishing diagnostic performance. The evaluation focuses on conformance to technical and safety standards.

8. Sample Size for the Training Set:

There is no mention of a training set or its sample size, as the document describes a diagnostic ultrasound system, not an AI/ML-driven device that typically undergoes a training phase.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as no training set is described in the document.

Ask a specific question about this device