(15 days)
The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
This is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ i/e, Vivid e Ultrasound) and does not contain detailed acceptance criteria and performance study results in the way a clinical trial submission for a novel device might.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores). Instead, it relies on a "substantial equivalence" argument to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.
| Acceptance Criteria (Not explicitly stated/quantified) | Reported Device Performance (Implicitly equivalent to predicate) |
|---|---|
| Safety: | Conforms with applicable medical device safety standards. |
| - Acoustic output | Evaluated and conforms. |
| - Biocompatibility | Evaluated and conforms. |
| - Cleaning and disinfection effectiveness | Evaluated and conforms. |
| - Electromagnetic compatibility | Evaluated and conforms. |
| - Thermal, electrical, and mechanical safety | Evaluated and conforms. |
| Effectiveness: | |
| - Overall performance | Comparable to predicate GE LOGIQ e and Venue 40. |
| - Key safety and effectiveness features | Same as predicate devices. |
| - Physical overall construction and materials | Same as predicate devices. |
| - Technological characteristics | Equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data is mentioned. The submission states: "Clinical Tests: None required." Therefore, there is no sample size for a test set and no data provenance (country of origin, retrospective/prospective). The rationale is that "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Diagnostic ultrasound has accumulated a long history of safe and effective performance."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical tests or test sets were used, no experts were involved in establishing ground truth for a test set.
4. Adjudication Method
Not applicable, as no test set or clinical data requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Tests: None required." The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness through head-to-head clinical trials with human readers.
6. Standalone Performance Study
No standalone performance study (algorithm only, without human-in-the-loop) was conducted or reported in this 510(k) submission. This device is a diagnostic ultrasound system, not an AI algorithm requiring standalone performance evaluation in the typical sense for medical imaging AI. Its performance is inherent in its imaging capabilities and user-controlled operation.
7. Type of Ground Truth Used
The ground truth for the device's performance, as argued in this 510(k), is essentially the established safe and effective performance of its predicate devices in clinical practice, along with compliance to recognized standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data for this specific submission's evaluation.
8. Sample Size for the Training Set
Not applicable. The GE LOGIQ i/e and Vivid e Ultrasound system is a conventional diagnostic ultrasound device, not an AI/machine learning model in the modern sense that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this conventional diagnostic ultrasound device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.