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The intended use of Philips 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 (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.

The clinical environments where Philips EPIQ 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 judgement and best clinical procedure.

The intended use of the Affiniti Series Diagnostic Ultrasound Systems is 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 (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, Lung.

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

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 healtheare 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 following two new Liver Fat Quantification software features:

• (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver
• (2) Hepato-Renal Index Quantification: a ratio measure of the echogenicity ('brightness') of the liver parenchyma relative to that of the adjacent renal cortex

The features provide the end user with the capability to calculate attenuation of the liver and an hepato-renal index ratio during an ultrasound exam using Philips EPIQ or Affiniti Ultrasound System. Previously cleared liver quantification tools available to the end user include Shear Wave Point Quantification (ElastPQ, cleared via K17207 on 04 Oct 2017) and Shear Wave Imaging (ElastQ, cleared via K181485 on 27 Jul 2018). These existing quantification features measure liver stiffness on real-time and retrospective images.

The provided text describes specific features related to liver fat quantification (Attenuation Quantification and Hepato-Renal Index Quantification) for Philips Ultrasound systems. However, it does not contain detailed information about acceptance criteria, the specific study that proves the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) comparative effectiveness studies.

The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and general design control activities. It mentions "Software Verification and Validation testing" and "Non-clinical bench performance testing" but does not provide the results of these tests in a detailed, quantitative manner against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document confirms the device's intended use and regulatory classification but lacks the specifics of performance studies that would typically include acceptance criteria and detailed study results.

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