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The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

Device Description

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 1 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.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System. It focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information, particularly regarding detailed performance metrics, study design, and ground truth establishment, is not present in this document.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's functionality. Instead, it relies on demonstrating that the DP-20 and DP-30 systems are substantially equivalent to predicate devices (Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System (K102991), and M7 Diagnostic Ultrasound System (K103677)).

The "performance" described is in terms of general characteristics and adherence to safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
Acoustic Output	Conforms with applicable medical safety standards (UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, IEC 62304)
Biocompatibility	Conforms with applicable medical safety standards
Cleaning and Disinfection Effectiveness	Conforms with applicable medical safety standards
Thermal Safety	Conforms with applicable medical safety standards
Electrical Safety	Conforms with applicable medical safety standards
Mechanical Safety	Conforms with applicable medical safety standards
Effectiveness/Functionality:
Ability to acquire and display ultrasound data in B-Mode, M-Mode, or combined B+M Mode	Functions as described (acquires and displays B-Mode, M-Mode, or combined B+M Mode data)
Intended Uses are comparable to predicate devices	Intended uses are consistent with traditional clinical practices, FDA guidelines, and established methods of patient examination. Broad range of applications (fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vascular, urology).
Technological Characteristics comparable to predicate devices	Has the same technological characteristics as predicate devices.
Key safety and effectiveness features comparable to predicate devices	Comparable in key safety and effectiveness features to predicate devices.
Basic operating modes comparable to predicate devices	Has the same basic operating modes as predicate devices.

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

The document does not describe any specific clinical or performance test set (dataset of cases) used to establish quantitative performance metrics. The demonstration of safety and effectiveness relies on adherence to established engineering and medical device standards, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients/images.

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

Not applicable. No ground truth establishment by experts for a specific test set is mentioned, as the submission is not based on a clinical performance study with a new algorithm or diagnostic aid requiring such validation.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and subsequent adjudication method are described 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

Not applicable. This is an ultrasound imaging system, and the submission does not involve an AI algorithm or a comparative effectiveness study of human readers with or without AI assistance.

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

Not applicable. This is a standalone ultrasound imaging system, not an algorithm. Its "standalone" performance is assessed at the system level through adherence to safety and operational standards and comparison to predicate devices.

7. The Type of Ground Truth Used

Not applicable in the context of a new diagnostic algorithm. The "ground truth" implicitly referred to is the established safety and performance of predicate ultrasound systems and compliance with international and national safety standards.

8. The Sample Size for the Training Set

Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set.

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

Not applicable for the reasons mentioned above.

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