(33 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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch LCD touch screen and color widescreen monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LOGIQ E10 device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. The document explicitly states that "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be limited, primarily referencing the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a diagnostic ultrasound system, the "acceptance criteria" are implied to be that the new device performs "as safe, as effective, and its performance is substantially equivalent to the predicate device(s)" (as stated in the conclusion). Specific quantitative acceptance criteria for image quality or diagnostic accuracy are not provided in this document, as clinical studies were not required. The performance is assessed by comparison to the established performance of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Conforms to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2). Acoustic power levels are below FDA limits. Transducer materials are biocompatible. |
| Effectiveness equivalent to predicate devices | Employs the same fundamental scientific technology as predicate device(s). Has the same clinical intended use and imaging modes as the predicate LOGIQ E9. Similar capability in terms of measurements, digital image capture, review, and reporting studies. |
| Substantial Equivalence to predicate devices | The new platform (LOGIQ E10) is substantially equivalent to the predicate devices (K163077 LOGIQ E9, K170445 LOGIQ S8, K172342 Voluson E6/E8/E10). This equivalence is based on similar technology, intended use, imaging modes, safety, and performance characteristics. Specific probes and features were migrated from other cleared GE devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned for a clinical performance study since none was required. The "testing" referred to in the document is primarily non-clinical, focusing on engineering verification and validation against technical standards and comparisons to existing predicate devices.
- Sample Size for Test Set: Not applicable, as no clinical test set was used/required for performance evaluation.
- Data Provenance: Not applicable for clinical test data. Non-clinical data would originate from internal GE Healthcare testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was required, and thus no ground truth established by experts for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The device described, LOGIQ E10, is a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device for image interpretation that would typically necessitate an MRMC study comparing human reader performance with and without AI assistance. The document focuses on the capabilities of the ultrasound system itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. The LOGIQ E10 is a diagnostic ultrasound imaging system; its "performance" is inherently tied to image acquisition and display, which is then interpreted by a human physician. It is not an algorithm designed for standalone diagnostic output.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for clinical performance studies. For non-clinical (engineering) verification, ground truth would be established through defined engineering specifications, phantom measurements (for acoustic output), and compliance with recognized standards.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/Machine Learning device that requires a training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/Machine Learning device.
§ 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.