(65 days)
The device is intended for use by a qualified physician for ultrasound evaluation of 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); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.
The provided text describes the GE LOGIQ E9 Diagnostic Ultrasound System and its various transducers. It highlights the device's indications for use and a summary of non-clinical tests conducted to prove its safety and substantial equivalence to predicate devices. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.
Therefore, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria, as no such clinical study is reported in the provided document.
Here's a breakdown of the information that can be extracted or inferred based on your prompt and the document:
1. A table of acceptance criteria and the reported device performance:
Since no clinical studies were performed, there are no specific performance metrics derived from such studies to present in a table. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.
| Acceptance Criteria (Inferred from Substantial Equivalence and Standards Adherence) | Reported Device Performance (as stated in document) |
|---|---|
| Safety: | Adherence to medical device safety standards. |
| Acoustic Output below FDA limits | Acoustic power levels are below applicable FDA limits. |
| Biocompatibility | Biocompatibility evaluated and found safe. |
| Cleaning and Disinfection Effectiveness | Cleaning and disinfection effectiveness evaluated. |
| Thermal, Electrical, Electromagnetic, Mechanical Safety | Conforms with applicable medical device safety standards. |
| Effectiveness (Substantial Equivalence): | Same fundamental scientific technology as predicate devices. |
| Intended Use | Same clinical intended use as predicate LOGIQ E9. |
| Imaging Capabilities | Same imaging modes as predicate LOGIQ E9 (with Shear Wave Elastography for Aixplorer). |
| Transducer Equivalence/Improvement | Transducers are identical to predicate LOGIQ E9 versions, or incremental improvements (C1-6VN-D, C2-9-VN-D). |
| Capability for Measurements, Digital Images, Reviewing, Reporting | Similar to predicate LOGIQ E9 systems. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable, as no clinical studies were conducted that would involve a "test set" of patients for performance evaluation. Non-clinical tests typically involve phantom, bench, or ex-vivo testing.
- Data Provenance: Not applicable for patient data, as no clinical studies were conducted. The document details adherence to international and national standards (AAMI/ANSI, IEC, NEMA, ISO), indicating these standards and tests were likely performed according to established protocols in manufacturing or testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as no clinical studies were conducted requiring ground truth established by experts for a patient test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies were conducted requiring adjudication for a patient test set.
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. The GE LOGIQ E9 is a diagnostic ultrasound system and the document does not suggest or describe any AI components or MRMC studies for improved human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the document does not describe standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth, as no clinical studies were described. For non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be defined by the specifications, standards, and established methodologies for each test (e.g., calibrated measurement devices for acoustic output).
8. The sample size for the training set:
Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.
9. How the ground truth for the training set was established:
Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.
§ 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.