(26 days)
The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300C, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.
5000 Compact series is indicated for diasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.
The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings 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. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
The proposed Philips 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are general purpose, compact, battery or alternating current (AC) powered, software controlled, diagnostic ultrasound systems. The ultrasound system is housed in a portable, laptop-style chassis. The ultrasound system function is to acquire ultrasound data and to display the data in various modes of operation. The ultrasound system components include the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger. The ultrasound system can be attached to an optional cart. The cart height is adjustable to accommodate a range of operator heights and operating positions. The cart has wheels for maneuverability and may provide isolated power for system and peripheral components (such as black and white image printer or a report printer).
The 5000 Compact Series Ultrasound Systems comprises of different configurations which differ in terms of features, transducer options, and license options (features available as purchasable options in addition to the standard features available in the system. The types of options available include clinical options, QLAB Advanced Quantification Software, protocols, imaging capabilities, connectivity capabilities, etc.). The 5500G is the primary configuration with the most available capabilities. Identical software architecture is used in all configurations and all configurations are derived from a common codebase. Similarly, the hardware is same for all configurations. All the 5000 Compact Series Ultrasound System configurations are compatible with existing Philips transducers cleared in Philips Affiniti Ultrasound System (K200304). 5500 Compact Series POC (point-of-care) configurations leverage POC features from the CX50 platform (K162329) to enable efficient POC ultrasound capability.
There is no information in the provided text about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification from Philips Ultrasound LLC to the FDA for "5000 Compact Series Ultrasound Systems." This type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove specific performance metrics against an AI.
The document states:
- "The proposed 5000 Compact Series Ultrasound Systems 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."
- "For testing, all pre-determined acceptance criteria were met." However, it does not specify what those acceptance criteria were or what performance data was collected to meet them.
Therefore, I cannot provide the requested information from the provided text, as it does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set (as no training set for an AI is mentioned).
- How ground truth for a training set was established.
The document focuses on demonstrating that the new ultrasound systems are substantially equivalent to existing, cleared predicate devices (Philips Affiniti Ultrasound System and Philips CX 50 Ultrasound Systems) based on their technological characteristics, intended use, and safety considerations, rather than reporting on a study with specific performance acceptance criteria for an AI or imaging diagnostic algorithm.
§ 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.