(112 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thvroid); 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, vascular and neurosurgical).
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm 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. This modification will provide users with 8 additional transducers, an additional optional feature called Elastography Imaging and an enhanced version of the commercially available Volume Navigation (V Nav) optional feature. These modifications all lead to overall quality and image enhancement.
Here's a summary of the acceptance criteria and study information for the GE LOGIQ E9 BT2010 Diagnostic Ultrasound System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K092271) for the GE LOGIQ E9 BT2010 system does not specify quantitative acceptance criteria or specific device performance metrics in a readily extractable table format for individual features (like Elastography or Volume Navigation).
Instead, the documentation relies on a general statement of compliance and equivalence:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| General Safety and Effectiveness Standards | Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety). |
| Complies with voluntary standards detailed in Sections 9, 11, 15, and 17 of the premarket submission. | |
| Elastography Imaging Mode | The elasticity imaging algorithm can differentiate different structures with different stiffness. |
| Volume Navigation (V Nav) Feature | The V Nav feature functions according to requirements and specifications. |
| Substantial Equivalence to Predicate Devices | The LOGIQ E9 BT2010 is of a comparable type and substantially equivalent to the GE LOGIQ E9, GE Vivid E9, and the Elastography Imaging feature from SonixTouch Ultrasound Scanner. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction, materials, intended uses, and basic operating modes as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, LOGIQ E9 BT2010, did not require clinical studies to support substantial equivalence."
This indicates that clinical test data (and thus a "test set" with a corresponding sample size and data provenance as would be customary for a clinical study) was not used to demonstrate the substantial equivalence of the modified device. The submission relies on non-clinical tests and comparison to predicate devices.
However, for the specific features:
- Elastography Imaging: The submission includes "DOC0605013 Verification Results Summary for Elastography Imaging". The document does not specify the sample size or provenance of data used in this verification, but it is implied to be non-clinical (e.g., phantom studies or controlled material tests) given the statement about not requiring clinical studies.
- Volume Navigation: The submission includes "DOC0631792 Verification Results Summary for Volume Navigation". Similar to Elastography, details on sample size and provenance are not provided, but it is implied to be non-clinical verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since clinical studies were not required and new features were validated through non-clinical verification, there is no mention of human experts being used to establish ground truth for a clinical test set. The "ground truth" for the non-clinical verification studies (e.g., for Elastography and V Nav) would likely be physical measurements, known properties of test materials (phantoms), or engineering specifications, rather than expert consensus on clinical images.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was utilized for human expert review and thus no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. The document describes a diagnostic ultrasound system and its features, not an AI-assisted diagnostic tool in the sense of image analysis that would typically involve MRMC studies to assess human reader improvement. The "Elastography imaging algorithm" is mentioned, but its performance is verified against the ability to differentiate stiffness, not as an AI assistant to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For the specific features mentioned:
- Elastography Imaging: A standalone algorithm verification was done, as evidenced by the "DOC0605013 Verification Results Summary for Elastography Imaging" which provides evidence that the algorithm can differentiate different structures with different stiffness. This verifies the algorithm's capability independent of human interpretation for basic feature function.
- Volume Navigation: A standalone verification was done for the V Nav feature, as evidenced by "DOC0631792 Verification Results Summary for Volume Navigation," which confirms it functions according to requirements and specifications.
7. The Type of Ground Truth Used
- Elastography Imaging: The ground truth for the Elastography imaging algorithm verification likely involved physical properties/measurements of materials with known varying stiffness (e.g., phantoms). The goal was to prove the algorithm could differentiate stiffness, implying a controlled environment with established ground truth for stiffness levels.
- Volume Navigation: The ground truth for Volume Navigation verification would be based on engineering requirements and specifications for tracking movement and needle tracking accuracy, verified against known positions or trajectories.
- Overall System: For the overall substantial equivalence claim, the "ground truth" implicitly refers to the performance and characteristics of the predicate devices (GE LOGIQ E9, GE Vivid E9, and SonixTouch Ultrasound Scanner's Elastography feature). The new device is determined to be equivalent based on having the same technological characteristics, safety, effectiveness, physical design, construction, materials, and intended uses.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device with updated features (additional transducers, enhanced Volume Navigation, and Elastography imaging functionality), not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the context of machine learning. The verification studies for the new features (Elastography, V Nav) would involve test data specific to their function, but not "training data."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set 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.