(29 days)
The intended use of the EPIQ 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 Echo), 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.
The clinical environments where the Philips EPIO Diagnostic Ultrasound Systems and Philips Affiniti 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 and used 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 user responsibility for sound clinical judgement and best clinical procedure.
The proposed Philips EPIQ Series 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).
Transducers are connected to the system using a plug in electrical connection. Other than the introductions of the new mC12-3 Transducer, the device description, accessories and components are unchanged.
The provided text is a 510(k) summary for the Philips EPIQ Series Diagnostic Ultrasound System and mainly focuses on demonstrating substantial equivalence to a predicate device. It contains very limited information regarding acceptance criteria and performance studies in the way typically expected for an AI/ML medical device.
Specifically, the document does not describe:
- A table of acceptance criteria for algorithm performance and reported device performance.
- Sample sizes used for a test set or its provenance.
- The number or qualifications of experts used for ground truth establishment.
- Adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of AI assistance for human readers.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for a training set or how its ground truth was established.
The document states:
- "Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures." (Page 6)
- "The proposed Philips EPIQ Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence." (Page 6)
- "For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the new mC12-3 transducer meet their intended use." (Page 7)
This suggests that the "testing" mentioned refers primarily to non-clinical performance data related to the safety and fundamental operation of the ultrasound system and its new transducer (mC12-3), rather than the performance of an AI/ML algorithm that predicts or classifies outcomes. The acceptance criteria met were likely related to electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility, as listed under "Nonclinical Performance Data" on page 6.
Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/ML component, as the submission appears to be for a traditional ultrasound system and transducer, not an AI/ML-driven diagnostic device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.