(29 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurological).
The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 52 cm wide, 99 cm deep and 135 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification makes a system with numerous high quality features available to diagnostic ultrasound users in a lower market segment.
GE Medical Systems' LOGIQ 5 Ultrasound System (K014097) is a diagnostic ultrasound system intended for various clinical applications. The submission states that "Clinical Tests: None required." This indicates that no specific clinical study was performed or considered necessary to prove the device meets acceptance criteria, beyond non-clinical testing and comparison to an already-marketed predicate device. Therefore, much of the requested information regarding clinical studies, sample sizes, expert ground truth, and adjudication methods is not applicable based on the provided document.
The acceptance criteria for this device appear to be primarily based on substantial equivalence to a predicate device, the GE LOGIQ 7 diagnostic ultrasound system (K010329), and adherence to various safety and quality standards.
Here's an attempt to fill in the table and address other points based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (GE LOGIQ 7, K010329) | "The GE LOGIQ 5 is of a comparable type and substantially equivalent to the current GE LOGIQ 7. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device." |
| Conformance with Applicable Medical Device Safety Standards | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." |
| Consistency with Traditional Clinical Practice, FDA Guidelines, and Established Patient Examination Methods | "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." |
| Conformance with Quality Systems | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems." |
| Safe and Effective Performance (Historical Context) | "Diagnostic ultrasound has accumulated a long history of safe and effective performance." |
| Functional Equivalence across various Clinical Applications and Modes of Operation (as detailed in Indications for Use forms for each transducer) | For each listed clinical application (e.g., Fetal, Abdominal, Cardiac, Small Organ) and mode of operation (B, M, PW Doppler, Color Doppler, etc.), the device is indicated to perform (marked 'P' for "previously cleared by FDA"). The specific performance metrics for these applications are not quantified in this document. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable, as no clinical performance study with a test set was conducted. The assessment was based on substantial equivalence and non-clinical testing.
- Data Provenance: Not applicable for a clinical test set. Non-clinical test data would originate from internal GE Medical Systems testing or certified external labs.
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 requiring expert ground truth was used for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was 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
- Not applicable. This device is a diagnostic ultrasound system, not an AI-powered diagnostic aide. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a hardware diagnostic ultrasound system, not an algorithm, and no standalone performance study was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a clinical performance study. The primary "ground truth" for demonstrating substantial equivalence was the predicate device (GE LOGIQ 7) and its established performance characteristics and safety profile, along with adherence to recognized safety and quality standards for ultrasound devices.
8. The sample size for the training set
- Not applicable, as the device is a hardware system, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as the device is a hardware system, not an AI/ML algorithm requiring a training set.
§ 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.