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

Modes of operation include: B Mode(3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler and Harmonic Imaging.

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 judgement and best clinical procedure.

The intended use of Affiniti Series Diagnostic Ultrasound System 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, Lung.

Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler and Harmonic Imaging.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, 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 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 purpose of this Traditional 510(k) Pre-Market Notification is to introduce the addition of the Artificial Intelligence (AI) Auto Measure Abdomen feature software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems.

The Auto Measure Abdomen feature on Philips EPIQ and Affiniti Series Diagnostic Ultrasound System aims to improve workflow efficiency by automating selected measurements required for routine abdominal and renal exams. The Auto Measure feature is designed to provide semi-automated and editable measures of abdominal organs such as kidney and spleen. The software provides a semi‑automated measurement capability. Users may adjust the position of the caliper end points for measurement refinement or perform additional manual measurements. The Auto Measure Abdomen feature is available in C5-1 and C9-2 transducers only.

The software applications are supported by all EPIQ and Affiniti models running software version 14.0 or higher.

Here's a breakdown of the acceptance criteria and the study details for the Auto Measure Abdomen feature, based on the provided FDA 510(k) clearance letter (K253595):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of subjects: 150 subjects (i.e., 150 ultrasound exams).
• Number of images (samples):
  • 292 images for kidney longitudinal view (for kidney length measurement).
  • 271 images for kidney transverse view (for kidney width and height measurement).
  • 145 images for spleen sagittal view (for spleen length measurement).
• Data Provenance: Images were collected from adults (≥18 years) enrolled at three clinical sites. The data included both patients referred for abdominal or renal ultrasound and healthy volunteers. The letter does not explicitly state the country of origin, but "three clinical sites" implies a multi-site collection, likely within the US, given the FDA context. The data appears to be previously collected ("ultrasound images previously collected"). It's a retrospective study for the AI evaluation, using prospectively collected patient data.

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

• Number of experts: 3 clinical experts.
• Qualifications of experts: All three experts are registered clinical sonographers with ten or more years of experience in general imaging and abdominal imaging, and each holds active certification by the American Registry for Diagnostic Medical Sonography (ARDMS).

4. Adjudication Method for the Test Set

• Method: The three clinical experts independently carried out manual measurements. The average values obtained from their measurements served as the ground truth. This is a form of expert consensus (averaging), without a specific 2+1 or 3+1 rule mentioned beyond averaging the three independent measurements. The experts also reviewed the AI algorithm-generated measurements to either accept or edit them, implying an expert-in-the-loop validation process for the AI output against their manual measurements.

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

• No, a formal MRMC comparative effectiveness study comparing human readers with and without AI assistance to measure a specific improvement effect size was not explicitly described in this document. The study focused on comparing the AI's measurements directly against expert ground truth. While experts were involved in generating ground truth and reviewing AI output, the study's primary endpoint was the concordance between AI measurements and expert measurements, not the increase in human reader performance with AI assistance.

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

• Yes, the primary evaluation was a standalone performance test of the AI algorithm. The study evaluated the "AI algorithm performance" by comparing its "algorithm-generated measurements" to the expert-derived ground truth. Although experts could edit the AI measurements, the core evaluation reported in the tables (AI Auto Measure (cm) Mean ± SD (Min, Max)) represents the algorithm's raw output before any human modification.

7. The Type of Ground Truth Used

• Type: Expert consensus (average values of measurements from three experienced clinical sonographers).

8. The Sample Size for the Training Set

• The document states, "The datasets used in the validation study and for regulatory clearance were distinct from those employed during algorithm training." However, the exact sample size for the training set is not provided in this document.

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

• The document states, "The datasets used in the validation study and for regulatory clearance were distinct from those employed during algorithm training." However, the method for establishing ground truth for the training set is not provided in this document. It only confirms independence from the validation set's ground truth.

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