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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The EPIQ Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists 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 user interface consists of a touch screen with soft key controls, and a QWERTY keyboard. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The EPIQ system uses standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as 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 industrystandard formats (Ex: 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 EPIQ system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The EPIQ system enables image guided navigation and image fusion via the optional PercuNav feature.

The Philips EPIQ Diagnostic Ultrasound System, K132304, is a general-purpose, software-controlled diagnostic ultrasound system. It is designed to acquire ultrasound data and display it in various modes for diagnostic purposes across a wide range of clinical applications. Its acceptance for marketing was primarily based on substantial equivalence to predicate devices, rather than new clinical trials demonstrating de novo safety and effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EPIQ Diagnostic Ultrasound System are not presented as a direct performance table with numerical targets. Instead, acceptance is based on demonstrating substantial equivalence to previously cleared devices (Philips iU22 Diagnostic Ultrasound System, K130499, K121498, K093563, K042540, K030455) and compliance with relevant safety standards.

The reported device performance, in terms of meeting acceptance criteria for substantial equivalence, is articulated as follows:

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

The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the EPIQ Diagnostic Ultrasound System." This means there was no specific "test set" of patient data in the context of a clinical study to evaluate the device's diagnostic performance against a ground truth. The device's acceptance was based on non-clinical performance data and its substantial equivalence to previously cleared devices.

Therefore, there is no sample size for a test set of patient data as part of this 510(k) submission, and consequently, no data provenance regarding country of origin or retrospective/prospective nature of such a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical trial or test set with patient data was utilized for performance evaluation against a ground truth, there were no experts used to establish ground truth for a test set. The evaluation focused on engineering and regulatory compliance, and comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set

As there was no clinical test set for performance evaluation, there was no adjudication method applied.

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

No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to demonstrate safety and effectiveness, rather than a direct comparison of human readers with and without AI assistance. The device is purely a diagnostic imaging system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

The device is a diagnostic ultrasound system. Its "performance" is inherent in its ability to acquire and display ultrasound data accurately according to its specifications and the standards it complies with. It is not an "algorithm only" device that provides interpretations or diagnoses. Its performance is fundamentally linked to human operation and interpretation. Therefore, the concept of "standalone performance" as it might apply to an AI algorithm providing diagnostic outputs (e.g., sensitivity/specificity) is not relevant or applicable here. The non-clinical performance data (e.g., phantom imaging, acoustic output measurements) would be a form of standalone testing of the system's technical capabilities.

7. The Type of Ground Truth Used

For non-clinical performance data validation, the "ground truth" would be established by technical standards and physical measurements (e.g., phantom studies for image quality, calibrated sensors for acoustic output, engineering specifications for software and hardware functionality). There was no "expert consensus, pathology, or outcomes data" ground truth used for determining the device's diagnostic accuracy in a clinical context within this submission, as a clinical trial was not performed.

8. The Sample Size for the Training Set

The document does not describe the development of a specific "training set" in the context of machine learning or AI models. The EPIQ Diagnostic Ultrasound System is presented as an evolution of existing ultrasound technology (Track 3 system and identical fundamental scientific technology to the predicate device). Therefore, there is no stated sample size for a training set as this is not a submission for an AI/ML-driven device that requires such training data to establish its core functionality.

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

Since no training set for an AI/ML model is mentioned or appears to be relevant to this submission, the question of how its ground truth was established is not applicable. The ground truth for validating the system's performance would relate to engineering and regulatory standards, and established metrics for ultrasound image quality and safety.

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