(56 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; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, 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 It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. 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.
The provided text is a 510(k) Summary and related Indications for Use forms for the GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound systems. It describes the device, its intended uses, and claims substantial equivalence to a predicate device.
Key takeaway: This documentation explicitly states, "Clinical Tests: None required." Therefore, there are no specific acceptance criteria or a study provided to prove the device meets performance criteria beyond safety and effectiveness compared to a predicate device. The information requested regarding performance metrics, sample sizes, expert qualifications, ground truth, and MRMC studies is not available in these documents because clinical studies were not performed for this 510(k) submission.
However, I can extract the information that is present concerning the device and its regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
As per the "Non-clinical Tests" section (Section b.1), the device was evaluated for its conformity with applicable medical device safety standards.
The core acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | The modified Compact Ultrasound devices are "virtually identical having the same design, construction, materials, brand names and intended uses. All technological characteristics and safety and effectiveness features are equivalent." The device conforms to applicable medical device safety standards. |
| Acoustic Output | Conforms with applicable medical device safety standards. |
| Biocompatibility | Conforms with applicable medical device safety standards. |
| Cleaning and Disinfection Effectiveness | Conforms with applicable medical device safety standards. |
| Electromagnetic Compatibility | Conforms with applicable medical device safety standards. |
| Thermal, Electrical, and Mechanical Safety | Conforms with applicable medical device safety standards. |
| Quality Systems Compliance | Design and development process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. Compliance verified through independent evaluation with ongoing factory surveillance. |
2. Sample size used for the test set and the data provenance
- No clinical test set was used. The submission explicitly states: "Clinical Tests: None required." This is a regulatory filing asserting substantial equivalence based on technical characteristics and safety standards, not a performance study using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As no clinical test set was used, no experts were required to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set and thus no adjudication method were used.
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
- No MRMC study was done. This device is an ultrasound imaging system, and the submission does not mention any AI components or features that would warrant an MRMC study comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an ultrasound imaging system, not an algorithm being tested in a standalone fashion.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical studies requiring ground truth were performed for this submission. The basis for clearance is substantial equivalence to a predicate device and compliance with safety standards.
8. The sample size for the training set
- Not applicable. No clinical training set was used as no new algorithm requiring such a set was part of this 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable. As there was no clinical training set, no ground truth needed to be established for it.
§ 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.