(122 days)
C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").
This FDA 510(k) premarket notification for the C5 Diagnostic Ultrasound System is for a general-purpose ultrasound device. It is a comparison to a predicate device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML study design is not applicable.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical performance acceptance criteria for diagnostic accuracy. Instead, substantial equivalence is claimed based on meeting various safety and performance standards. The "device performance" in this context refers to its ability to meet these general standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety (IEC 60601-1) | Fully meets the standards requirement |
| EMC (IEC 60601-1-2) | Fully meets the standards requirement |
| Biocompatibility (ISO 10993-5) | Fully meets the standards requirement |
| Biocompatibility (ISO 10993-10) | Fully meets the standards requirement |
| Performance Safety and Effectiveness (IEC 60601-2-37) | Fully meets the standards requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not performed for C5 Diagnostic Ultrasound System as part of the submission." Therefore, there is no test set of patient data, no sample size for such a set, and no data provenance from patients mentioned. Technical performance tests were conducted on the device itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no clinical testing with patient data or ground truth established by experts was performed for this submission.
4. Adjudication Method
Not applicable, as no clinical testing with patient data was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is a general-purpose ultrasound system and not an AI-assisted device. The submission explicitly states, "Clinical testing was not performed."
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this is a physical diagnostic ultrasound system, not a standalone algorithm. The submission explicitly states, "Clinical testing was not performed."
7. Type of Ground Truth Used
Not applicable, as no clinical testing with patient data requiring ground truth was performed. Performance was evaluated against recognized industry standards for safety and technical performance.
8. Sample Size for the Training Set
Not applicable, as no AI/ML algorithm requiring a training set is mentioned or evaluated in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI/ML algorithm or training set is mentioned.
§ 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.