(14 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human follows:
Clinical Application: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify)6, Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify)7, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Specify), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Specify), Peripheral vessel, Other (Specify), Musculo-skel (conventional), Musculo-skel (superficial)
Mode of Operation: B, M, PWD, CWD, Color Doppler, Combined, Others
Notes:
- Combined modes are: B+M, B+M+Color, B+PW, B+PW(CVI), B+PW+Color
- Harmonics (Tissue and Contrast) - Previously Cleared
- Angio - Previously Cleared
- Real-time 3D imaging- New
- Real-time Bi-plane imaging- New
- Intraoperative applications include: Cardiac, Vascular Previously Cleared
- Small Parts applications include: Thyroid, scrotum, prostate, breast - Previously Cleared
The M2424 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 transducer. It is substantially equivalent to the generic class of ultrasound systems including previous versions of the Philips Medical Systems M2424 (K002470) system and the Voluson 730 (K003525).
The 21315 transducer is substantially equivalent to the generic class of ultrasound transducers including previously cleared Philips Medical Systems transducers (K002470).
The M2424 system and 21315 transducer function in a manner identical to all ultrasound systems and transducers. 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 a 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, processed, and sent back to the system. In the system, advanced signal processing technologies further 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.
The provided text is a 510(k) summary for the Philips Ultrasound M2424 Diagnostic Ultrasound System with the 21315 ultrasound transducer. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. Crucially, this document is a regulatory submission for a diagnostic ultrasound system, not an AI/ML powered device. Therefore, the concepts of acceptance criteria, study design for AI performance, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not directly applicable in the AI/ML context that your detailed questions imply.
The information provided focuses on demonstrating the device's technical specifications, safety, and equivalence to existing ultrasound systems, rather than advanced algorithmic performance.
Here's an analysis of what can be extracted, acknowledging the limitations for an AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't outline specific, quantitative acceptance criteria in the way one would expect for an AI/ML model's performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for this traditional medical device are regulatory in nature, based on demonstrating substantial equivalence to predicate devices.
The "reported device performance" is framed in terms of meeting these equivalence criteria:
| Acceptance Criteria (Regulatory Equivalence) | Reported Device Performance |
|---|---|
| 1. Intended Use Equivalence: Indications for use are same as predicate device. | The M2424 system with the 21315 transducer is "intended for diagnostic ultrasound imaging and fluid flow analysis." This is stated to be substantially equivalent to predicates having the "diagnostic ultrasonic imaging and fluid flow analysis." |
| 2. Technical Capabilities Equivalence: Same gray-scale and Doppler capabilities. Equivalent technologies for imaging, Doppler functions, and signal processing. | "Both the predicate device and the M2424 have the same gray-scale and Doppler capabilities." "Both the predicate device and the M2424 use essentially the same technologies for imaging, Doppler functions and signal processing." |
| 3. Safety Standards Equivalence: Acoustic output levels below FDA limits. Manufactured under equivalent quality systems. Made of materials with equivalent biosafety. Designed and manufactured to the same electrical and physical safety standards. | "Both the predicate device and the M2424 have acoustic output levels below the applicable FDA limits." "Both the predicate device and the M2424 are manufactured under equivalent quality systems." "Both the predicate device and the M2424 are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application." "Both the predicate device and M2424 are designed and manufactured to the same electrical and physical safety standards." A special report on acoustic output measurements based on production line devices is required post-clearance. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document as it pertains to a traditional device clearance, not an AI/ML performance study. There isn't a "test set" in the sense of a dataset for evaluating algorithm performance. The evaluation is based on engineering comparisons and adherence to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided and is irrelevant for a traditional ultrasound device submission. There is no concept of "ground truth" established by experts for image interpretation in the context of this 510(k) summary, as it's not an AI/ML product.
4. Adjudication Method for the Test Set:
This information is not provided and is irrelevant for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, which is not applicable to a conventional ultrasound system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This pertains to AI/ML models, which this device is not. The M2424 is the diagnostic ultrasound system itself, not an algorithm that interprets images.
7. The Type of Ground Truth Used:
Not applicable. For a diagnostic ultrasound system, the "ground truth" of its operation is its ability to produce diagnostic images and perform fluid flow analysis as intended, verified through engineering tests and comparison to predicate devices, rather than through labeled data for an algorithm.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As a traditional ultrasound system, there is no "training set" or a process of establishing ground truth for it in the AI/ML sense.
§ 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.