(11 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications: Ophthalmic, Fetal, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, breast, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel (conventional), Musculo-skel (superficial), Intra-luminal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Other (Carotid, I/O).
Modes of Operation: B, M, PWD, CWD, Color Doppler, Combined (Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual), Other (Panoramic, Color Power Angio (CPA, formerly Angio), 3D/4D, Harmonics (Tissue and Contrast), Directional Angio Imaging, Tissue Doppler Imaging, Amplitude Doppler).
The HD15 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed HD11 Diagnostic Ultrasound System (K043535 and K062247). The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.
Here's an analysis of the provided text regarding the Philips HD15 Diagnostic Ultrasound System, focusing on acceptance criteria and supporting studies:
Assessment of the Provided Information:
The provided document is a 510(k) Premarket Notification for the Philips HD15 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (HD11 Diagnostic Ultrasound System, K043535 and K062247).
A key aspect of substantial equivalence is demonstrating that a new device is as safe and effective as a legally marketed predicate device. This K-number document is not a clinical study report that establishes performance against standalone acceptance criteria. Instead, it attests that the new device's performance is equivalent to that of existing, cleared devices.
Therefore, the requested information elements related to specific performance metrics, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies will largely be absent from this type of regulatory submission because the device is cleared based on demonstrating equivalence, not novel performance against pre-defined metrics.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, this submission demonstrates substantial equivalence rather than establishing new performance criteria. Therefore, there are no explicit acceptance criteria for this specific device's novel performance or reported quantitative performance metrics in the format typically seen in a clinical study for a new, non-equivalent device.
The "acceptance criteria" here are effectively met by demonstrating:
- Same Indications for Use: The HD15 is indicated for the same diagnostic ultrasonic imaging and fluid flow analysis as the predicate device.
- Same Capabilities: Both have the same gray-scale and Doppler capabilities.
- Same Technologies: Both use essentially the same technologies for imaging, Doppler functions, and signal processing.
- Acoustic Output: Both have acoustic output levels below the Track 3 FDA limits.
- Quality Systems & Biosafety: Both are manufactured under equivalent quality systems and from materials with equivalent biosafety.
- Safety Standards: Both are designed and manufactured to the same electrical and physical safety standards.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of validating novel performance data. The clearance is based on the device's functional equivalence to already-cleared predicate devices. Therefore, there are no patient or image data sets used for testing described in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. There is no "ground truth" establishment described in relation to a test set, as the clearance is based on substantial equivalence to existing devices, whose efficacy and safety were presumably established previously.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study involving AI or human reader performance improvement. It's a regulatory submission for a diagnostic ultrasound system based on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The HD15 is deemed safe and effective because it is substantially equivalent to a device already cleared by the FDA. There is no new primary "ground truth" established for the HD15 in this document.
8. The Sample Size for the Training Set
Not applicable. This device is an ultrasound system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is an ultrasound system, not an AI algorithm requiring a training set and associated ground truth.
Conclusion:
The provided document is a 510(k) Premarket Notification which demonstrates substantial equivalence of the Philips HD15 Diagnostic Ultrasound System to existing cleared devices. It does not describe a clinical study with specific acceptance criteria, test sets, ground truth establishment, or performance metrics against novel claims. Instead, its "proof" is the detailed comparison to predicate devices, showing that it functions identically, uses similar technologies, and meets the same safety standards.
§ 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.