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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

This SonoScape X5 Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The X5 Series system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and auto-correlation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.

This system (X5 Series Digital Color Doppler Ultrasound System) are additional models (X5 Exp, X5 Pro, X6, X6 Exp, X6 Pro), additional transducers (C1-6, 12L-B, 9L-A, 18L-A, 13L-A, L746, 10L-I, 1012, 6V7, 6V3, 6V3A, C361, VC6-2, C542, C322, 12LT-A, 12LI-A, 6CT-A, 6CI-A, BCC9-5, S1-5, 2P1, CWD5.0, CWD2.0, MPTEE and MPTEE min probes), additional functions (Elastography, Contrast imaging) and updated intended use (Trans-esoph.(Cardiac)) to legally marketed SonoScape X5 (K160258).

The provided document describes the Sonoscape Medical Corp.'s X5 Series Digital Color Doppler Ultrasound System (K182648) and its substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific performance acceptance criteria for a diagnostic AI algorithm.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices by comparing intended use, technical characteristics, and probes, as well as adherence to recognized safety and performance standards. No information regarding an AI algorithm's performance or study details (like sample size for test sets, ground truth establishment, expert qualifications, or MRMC studies) is present.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves an AI device meets these criteria, as the provided text pertains to a general diagnostic ultrasound system and its transducers, not an AI-powered diagnostic tool.

The "Performance test" section under "Non-Clinical Tests" lists compliance with electrical safety, EMC, acoustic testing, and software verification/validation standards, indicating the device meets these standards. However, these are general device safety and performance criteria, not specific diagnostic performance criteria for an AI algorithm.

Disclaimer: The provided document is a 510(k) summary for a medical device and does not contain details about the performance of an AI algorithm or a study testing such an algorithm. The information below is based solely on the content available in the provided text, which primarily addresses the substantial equivalence of a physical ultrasound system to predicate devices. As such, many of the requested fields are not applicable or cannot be extracted from this document because it does not describe an AI medical device or its validation study.

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Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel. The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application. The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips CX50 and Sparq Diagnostic Ultrasound Systems are implicitly defined by compliance with several international and FDA-recognized consensus standards, as well as the FDA's specific guidance for diagnostic ultrasound systems. The reported device performance is that it complies with these standards and guidances, and meets the acceptance criteria.

• Indication for use
• Technological characteristics
• Non-clinical performance testing
• Safety and effectiveness
  These devices share the same gray-scale and Doppler capabilities, fundamentally identical scientific technology, same materials (bio-safety), equivalent quality systems, and same electrical and physical safety standards. | This is the primary conclusion of the submission, based on the non-clinical testing, confirming that the device meets the acceptance criteria for substantial equivalence to the predicate devices. |

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

The document explicitly states: "The modified CX50 and Sparq Diagnostic Ultrasound Systems did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System and reference predicate EPIQ Diagnostic Ultrasound System was demonstrated with the following attributes: • Indication for use; • Technological characteristics; • Non-clinical performance testing; and • Safety and effectiveness." (Page 39)

Therefore, there appears to be no separate clinical test set in the traditional sense for evaluating the performance of the modified device against specific clinical metrics. Instead, the performance was established through non-clinical testing and comparison to legally marketed predicate devices.

The data provenance for the modifications is based on the previously cleared predicate device (CX50, K123754) and reference device (EPIQ/Affiniti, K160807), which would have undergone their own testing. The current submission relies on the established safety and effectiveness of these predicates.

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

Since no clinical test set was required for the modified device, there's no information provided about experts establishing ground truth for a test set. The evaluation was primarily non-clinical and comparative.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with human interpretation was conducted for this specific 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No MRMC comparative effectiveness study was mentioned or indicated as being performed for this submission. The submission explicitly states "did not require clinical data."

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

This refers to a diagnostic ultrasound system, which is a hardware device with software, not typically a standalone algorithm like AI software. The performance assessment was based on the system's ability to acquire and display ultrasound data in various modes, complying with established physical and safety standards. Therefore, an "algorithm only" standalone performance study in the context of an AI-driven system is not applicable here.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by the engineering and quality control standards defined in the referenced IEC and ISO standards. This includes:

• Engineering specifications and measurements for acoustic output (e.g., ISPTA, MI, TI).
• Compliance with electrical and physical safety requirements.
• Biocompatibility testing against ISO 10993 standards for materials.
• Verification and validation against system requirements and risk controls.

The ground truth for the predicate devices (K123754 and K160807) would have involved comprehensive testing for their initial clearances, which may have included a combination of phantom studies, animal studies, and potentially clinical studies to establish their diagnostic capabilities. However, this submission specifically highlights that additional clinical data was not required due to the substantial equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The system's functionalities are based on established ultrasound physics and engineering principles, not statistical learning from data.

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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