FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
First, second and third trimester pregnancy studies.
Prostate, bladder and rectum visualization.

Device Description

The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M. The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.

AI/ML Overview

The provided 510(k) summary for the Sounmed SD-2000 Plus Portable Ultrasound scanner indicates that clinical tests were "Not Required" for this device. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its performance in clinical use.

The document states that the conclusion drawn from testing is that the device "is as safe, as effective as well as the legally marketed predicate devices." This implies that the acceptance criteria are met through substantial equivalence to a predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) rather than new clinical performance data.

However, based on the information provided, here's a breakdown of what can be inferred about the acceptance criteria and the "study" that supports the device's clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical studies were not required and no specific performance metrics beyond "safe and effective" equivalence are reported from patient data, a direct table of quantitative acceptance criteria and device performance is not available in the provided text.

The "acceptance criteria" in this context are primarily qualitative and based on demonstrating that the new device shares similar technological characteristics, intended uses, and safety standards with a legally marketed predicate device, thereby inferring similar performance.

Implicit Acceptance Criteria (based on substantial equivalence):

Acceptance Criteria Category	Description	Reported Device Performance
Safety	The device is designed, manufactured, and operates in a manner that does not pose undue risk to patients or users. Conforms to relevant safety standards (e.g., EN60601-1, ISO 14971).	"The device is as safe... as the legally marketed predicate devices." Conforms to listed safety standards.
Effectiveness	The device is capable of performing its intended diagnostic ultrasound imaging and fluid flow analysis functions as described in its indications for use, without significant differences in imaging quality or diagnostic capability compared to the predicate device. Conforms to relevant performance standards (e.g., EN61157 for acoustic output, functional similarity to predicate).	"The device is as... effective as the legally marketed predicate devices." Operating modes and supported probes are comparable to predicate.
Intended Use	The clinical applications for which the device is indicated are consistent with those of the predicate device or a subset thereof.	Intended uses (Fetal-OB/GYN, Abdominal, Small Organs, Trans-Vaginal, Trans-Rectal) are listed, similar to predicate.
Technological Equivalence	The fundamental technological characteristics (e.g., piezoelectric material, operation modes, imaging principles) are substantially similar to the predicate device.	"operates identical to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
Quality System	Device manufacturing meets established quality management system standards (e.g., ISO 13485:2003, ISO 9001:2000).	Conforms to ISO 13485:2003 and ISO 9001:2000.
Electromagnetic Compatibility	The device meets electromagnetic compatibility requirements (e.g., EN60601-1-2).	Conforms to EN60601-1-2.
Acoustic Output	The device's acoustic output falls within safe and declared limits.	Compliance with EN61157, with a post-clearance special report required for production line devices.

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

Sample Size: Not applicable. No clinical test set data from human subjects is mentioned for performance evaluation.
Data Provenance: Not applicable. The "study" relied on technical comparisons and adherence to standards, not patient data in the context of a clinical trial.

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

Not applicable. Since no clinical test set was required, there was no ground truth establishment by experts for such a set described in this document.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was utilized.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Tests: Not Required".

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an ultrasound system and transducers, which are hardware components for imaging. The concept of "standalone algorithm performance" is not relevant here as there's no mention of an embedded AI algorithm being evaluated separately. The clearance is for the imaging system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is effectively the predicate device's established safety and effectiveness, and compliance with international and national standards for medical electrical equipment and diagnostic ultrasound. The FDA's determination of "substantial equivalence" serves as the validation.

8. The sample size for the training set

Not applicable. This document describes the clearance of an ultrasound imaging system, not an AI/ML algorithm that would require a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI/ML algorithm is mentioned.

In summary, the "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to a legally marketed predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) and adherence to a list of relevant safety and performance standards. No human clinical trial data or performance metrics from a test set were required or presented in this 510(k) summary.

Summary

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.