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The Digital Ultrasonic Diagnostic Imaging 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.

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

The provided document (K130833) is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging Systems.

Based on the content of this document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through conformity to recognized standards and successful completion of non-clinical tests.

The acceptance criteria for this submission are implicitly that the device performs functionally and safely at least as well as the predicate devices and meets relevant medical device safety standards. The reported device performance is stated as conforming to these standards and being substantially equivalent to the predicate devices.

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

The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission, DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of any size used for performance evaluation that is described in this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

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

As no clinical studies or test sets of patient data were conducted or described, no experts were used to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies or test sets of patient data were performed or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC study was done, as the document explicitly states that clinical studies are "Not applicable." The submission relies on substantial equivalence to predicate devices and non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is an ultrasonic diagnostic imaging system, not an AI algorithm. Its performance is inherent in its imaging capabilities, which are assessed through technical and safety standards rather than standalone algorithmic performance metrics. Therefore, a "standalone algorithm performance" study as typically understood for AI was not conducted. The non-clinical tests serve as the standalone evaluation of the device's technical performance and safety.

7. The Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" essentially refers to:

• Conformity with established medical device safety and performance standards (e.g., IEC 60601 series, UEMA UD 2, UEMA UD 3, UL 60601-1, ISO14971, ISO 10993-1, IEC 62366, IEC 62304).
• Equivalence to the performance of predicate devices already cleared for market (Mindray DP-20/DP-30 (K113153), Mindray Z6 (K122010), Mindray M7 (K121010)). This implies that the predicate devices' established safety and effectiveness serve as the ground truth reference.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data. The "design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems" (Page 3), which implies robust engineering and manufacturing processes rather than data-driven training.

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

Not applicable, as there is no training set for this type of device.

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