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The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes.

It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid.

The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals.

The Portable Digital Color Doppler Ultrasound System is a portable, general-purpose, software-controlled ultrasound system. It consists of a handheld ultrasound main unit and software. The system is engineered to produce real-time ultrasound images, with an emphasis on capturing detailed anatomical structures and evaluating blood flow patterns using color Doppler technology. It includes features for measurements, image storage and review, as well as printing and recording capabilities. This portable system enables point-of-care ultrasound applications, providing healthcare professionals with a convenient way to visualize anatomical structures and assess blood flow dynamics.

This document is a 510(k) Pre-market Notification for a Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L). The information provided focuses on demonstrating substantial equivalence to already-cleared predicate devices, rather than presenting a standalone study with specific performance acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth are not available within this document. The submission primarily relies on non-clinical testing to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) like you would find in a clinical study report for an AI/algorithm-driven device.

Instead, the "acceptance criteria" here are implied by compliance with recognized standards and the demonstration of equivalent technical and performance properties to predicate devices. The document essentially states that the device "passed testings according to" various standards (listed below) and that "the proposed devices are substantially equivalent to the predicate devices" because "the minor differences don't raise any additional questions on effectiveness."

Therefore, a table of specific acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity) cannot be generated from the provided text. The document focuses on showing compliance with general safety and performance standards for ultrasound systems.

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

Not provided. This document details non-clinical testing for compliance with standards, not a clinical test set with specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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 test set is described in this document. The testing described is primarily non-clinical compliance testing.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method for a test set is described.

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

No. A MRMC comparative effectiveness study is not mentioned or implied. This device is an ultrasound system, not an AI or algorithm-assistance tool for human readers in the context of diagnostic interpretation.

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

Not applicable. This device is an ultrasound system, not a standalone algorithm/AI for diagnostic interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The document describes non-clinical testing against established engineering and safety standards for ultrasound devices, not against a clinical ground truth for diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device is an ultrasound imaging system, not an AI/algorithm that requires a training set.

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

Not applicable. As no training set is mentioned, the method for establishing ground truth for a training set is not applicable.

Summary of Available Information from the Document:

The document emphasizes non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety and general performance in accordance with recognized standards.

Non-clinical Testing Summary (from Section 5 of the 510(k) Summary):

The Portable Digital Color Doppler Ultrasound System has passed testing according to the following standards:

1. ANSI AAMI ES60601-1:2005/R12012 & A1:2010/R)2012 & A2:2010/RJ2012 (Cons. Text) Incl. AMD2:2021): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
3. IEC TR 60601-4-2 Editor 1.0 2016-05: Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity performance of medical electrical equipment and medical electrical systems.
4. IEC 60601-1-6 Editor 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: Safety and essential performance - Collateral standard: Usability.
5. IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices.
6. IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
7. IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION: Ultrasonics - Field characterization - Test methods for the measurement of mechanical indices related to medical diagnostic ultrasonic fields.
8. NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output for Diagnostic Ultrasound Equipment.
9. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software life cycle processes.

Conclusion stated: The non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

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