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The intended use of EPIQ Series 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, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal. Transvaginal. Lung.

· The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

• When 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 systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

· However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the mL26-8 transducer:

The mL26-8 is a linear array transducer designed primarily for superficial high-resolution imaging in Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, and Small Organ (Breast, Thyroid, Testicle). The mL26-8 has a frequency of 6-13.33 MHz.

The provided text describes the regulatory clearance of a Philips EPIQ Series Diagnostic Ultrasound System with a new mL26-8 transducer (K231190). However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm's performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K212704) and a reference device (K162329) by adhering to general safety and performance standards for diagnostic ultrasound systems. The "acceptance criteria" mentioned in the document refer to the successful completion and meeting of requirements for non-clinical performance tests, and design control activities for the ultrasound system itself, not for an AI or algorithmic component.

Specifically, the document states:

• "VIII. Clinical Data: The proposed EPIQ Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes: Design features, Indications for use, Fundamental scientific technology, Non-clinical performance testing, Safety and effectiveness."
• "IX. Conclusion: For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed EPIQ Series Diagnostic Ultrasound System, including mL26-8, met the intended use."

Therefore, based on the provided text, I cannot complete the table or answer the specific questions related to AI/algorithm performance. The document describes the clearance of an ultrasound hardware system, not an AI-powered diagnostic algorithm.

If you have a document that describes the validation of an AI component of this or another device, please provide that text.

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