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The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/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 proposed Philips EPIQ Diagnostic Ultrasound Systems and Philips Affiniti 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).

The removable transducers are connected to the system using a standard technology, multi-pin connectors. Other than the introductions of the two new transducers, the device description, accessories and components are unchanged, reference table 1.

Here's the breakdown of the acceptance criteria and supporting studies for the Philips EPIQ and Affiniti Diagnostic Ultrasound Systems based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the device's original clearance. Therefore, information regarding specific clinical performance metrics (like sensitivity, specificity, accuracy) from a de novo study is not present. Instead, the document emphasizes compliance with standards and equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device meeting safety and performance standards rather than specific clinical performance metrics like sensitivity/specificity for a novel algorithm.

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The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:
Fetal/Obstetric, Abdominal, Intraoperative (Vascular), Intraoperative (Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal), Cephalic (Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial) Gynecological, Other: Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Cardiac other (Fetal), Peripheral Vessel, Cerebral Vascular.
When Philips EPIQ system is integrated with Philips EchoNavigator. the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

The proposed EPIO and Affiniti 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).
The removable transducers are connected to the system using a standard technology, multipin connectors.

The acceptance criteria for the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 30, 50, and 70 Diagnostic Ultrasound Systems, are detailed via compliance with several international and FDA-recognized consensus standards for medical electrical equipment and diagnostic ultrasound. The reported performance is that the devices meet these standards and are substantially equivalent to their predicate devices.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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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), Fetal/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 proposed EPIQ and Affiniti 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). The removable transducers are connected to the system using a standard technology, multi-pin connectors.

Here's an analysis of the acceptance criteria and supporting studies for the Philips EPIQ and Affiniti Diagnostic Ultrasound Systems based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for diagnostic tasks). Instead, it focuses on demonstrating compliance with recognized safety and performance standards for ultrasound devices, and equivalence to predicate devices. The "performance" described relates more to meeting these technical and regulatory standards.

However, based on the Safety Considerations and Nonclinical Performance Data sections, we can infer the following:

• Ispta.3 ≤ 720 MW/cm2
• MI

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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), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 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 user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use 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 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 proposed EPIQ and Affiniti 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. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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