Search Results

The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Pocket Ultrasound System C10 is designed to be a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data through an off-the-shelf (OTS) Android device. the system mainly includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The other one is the software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.

The system is only intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Pocket Ultrasound System comprises the following:

• A commercial off-the-shelf (COTS) Android smartphone/tablet device.

· the software application (MY USG) running as an App on the COTS device with Android system.

• The ultrasound equipment/Transducers: C10

• Accessory: Wireless Battery Charger & Power Adapter

Different type transducers are available for the Pocket Ultrasound System C10, the frequencies are 2.5 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System C10 is designed with four ultrasound modes of operation, including B-mode, Combination Mode (B+M mode), Color Doppler mode and Pulsed Wave Doppler mode.

Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color Doppler mode and Pulsed Wave Doppler mode. Combination mode B+M-mode is the combination of the B-mode and M-mode of operation, superimposed on the display. Mmode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it's usually applied in diagnosis of cardiovascular diseases.

The system provides real-time images for tissues, organs or blood flow via touch screen of the COTS Android smartphone/tablet device, which, in combination with the embedded software system contained in the ultrasound device, provides users a friendly and convenient graphical interface and makes users be able to easily control the whole system.

The provided text is a 510(k) Summary for the Beijing Konted Medical Technology Co., Ltd. Pocket Ultrasound System (C10). It aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria through a clinical or performance study in the way one might for a novel AI/ML device. Therefore, much of the requested information (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test set, training set ground truth establishment) is not present because this document is focused on demonstrating substantial equivalence to an existing cleared device through non-clinical testing and comparison.

The document states:

• "No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its primary predicate device." (Page 21)
• "Non-clinical testing for Pocket Ultrasound System C10 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the primary predicate device." (Page 19)

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this specific device based on the provided text, nor can I describe an MRMC comparative effectiveness study or standalone performance data. The "acceptance criteria" here are implied to be the successful demonstration of equivalence through non-clinical testing and comparison to the predicate device, rather than quantitative performance metrics from a diagnostic accuracy study.

However, I can extract information related to the non-clinical performance and the rationale for claiming substantial equivalence:

Acceptance Criteria (Implied by Substantial Equivalence and Non-Clinical Testing):

The implied "acceptance criteria" for this 510(k) submission are that the device:

• Has the same intended use as the predicate device.
• Has similar technological characteristics, or that differences do not raise new questions of safety or effectiveness.
• Meets relevant performance and safety standards.

The "Study" (Non-Clinical Testing and Comparison):

The "study" that proves the device meets (implied) acceptance criteria is a combination of:

1. Comparison of Technological Characteristics: A detailed comparison table and discussion highlighting similarities and differences between the subject device (Pocket Ultrasound System C10) and the primary predicate device (Philips Lumify Ultrasound System - K162549) and a reference device (GuangDong Youkey Medical Co., Ltd. Pocket Ultrasound System - K211746).
2. Non-Clinical Performance Testing: Verification against various national and international standards for electrical safety, electromagnetic compatibility, usability, software validation, cybersecurity, wireless coexistence, biocompatibility, and diagnostic ultrasound performance.

Here's the information extracted from the provided text as it relates to your request, noting where the information is not applicable due to the nature of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present a clinical study with quantitative performance metrics for diagnostic accuracy. The "acceptance criteria" discussed are largely met by demonstrating compliance with standards and equivalence to a predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The document explicitly states "No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence..." (Page 21). The testing described is non-clinical performance and safety testing.
• Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed by Beijing Konted Medical Technology Co., Ltd. (China) or by test labs they contracted for standard compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set with human-established ground truth was used for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set was used.

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 MRMC comparative effectiveness study was done. This is not an AI/ML device, but a medical imaging hardware/software system.

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

• Not applicable. This is not an AI/ML diagnostic algorithm product.

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

• Not applicable. Clinical ground truth was not established as no clinical studies were performed. The "ground truth" for the non-clinical testing refers to the established standards and specifications that the device's performance was compared against.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set for model development.

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

• Not applicable. No training set was used.

Ask a specific question about this device