(51 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; and Intraoperative (abdominal, thoracic, vascular).
When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.
This document is a 510(k) premarket notification for the GE Healthcare LOGIQ P9 and LOGIQ P7 ultrasonic imaging systems. It asserts substantial equivalence to predicate devices, meaning that clinical studies were not required to demonstrate safety or effectiveness for the new device. Therefore, no acceptance criteria in terms of clinical performance metrics, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies are applicable or reported here.
The document focuses on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) premarket notification establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, there are no specific performance-based acceptance criteria or reported device performance in the format of a quantitative clinical study outcome table. The "performance" is implicitly deemed equivalent to the predicate devices through a qualitative comparison.
The acceptance criteria here would be compliance with recognized medical device safety standards and demonstration of technological equivalence to already cleared devices.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance/Compliance |
|---|---|---|
| Device Intent | Intended Use Equivalence: The new device (LOGIQ P9 and LOGIQ P7) must have the same intended use as the predicate device(s). | The LOGIQ P9 and LOGIQ P7 system's intended use for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology; Transvaginal; and Intraoperative applications is stated to be substantially equivalent to the predicate devices and existing LOGIQ P9/P7 systems. The Pinpoint™ GT Technology is also deemed equivalent in its intended use for magnetic needle tracking. |
| Technology | Technological Characteristics Equivalence: The new device must employ the same fundamental scientific technology as its predicate devices, or if different, the differences do not raise new questions of safety or effectiveness. | The LOGIQ P9 and LOGIQ P7 employs the same fundamental scientific technology as its predicate devices. The addition of new transducers (L12n-RS, P6D) and minor image rotation capabilities are considered not to raise new questions. |
| Safety | Compliance with Safety Standards: The device must meet recognized electrical, thermal, mechanical, acoustic, and electromagnetic safety standards. | |
| Biocompatibility: Materials in patient contact must be biocompatible. | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It conforms to applicable medical device safety standards including AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, and ISO14971. Transducer and patient contact materials are biocompatible. Acoustic power levels are below FDA limits. | |
| Performance (Non-Clinical) | Measurements, Digital Image Capture, Review, Reporting Equivalence: The new device must have similar capabilities in these aspects compared to predicate devices. | |
| Image Rotation: New rotational capabilities should be minor changes to previously cleared functionality. | ||
| Quality Assurance: Application of robust quality assurance measures during development. | The LOGIQ P9/P7 systems have similar capabilities to predicate LOGIQ P9/P7 systems in terms of performing measurements, capturing digital images, reviewing, and reporting studies. Image rotation for 90° and 270° is a minor change to the previously cleared 180° rotation. Quality assurance measures applied include Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing (Module verification), Integration testing (System verification), Performance testing (Verification), and Safety testing (Verification). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states: "The subject of this premarket submission, LOGIQ P9 and LOGIQ P7, did not require clinical studies to support substantial equivalence." Therefore, no test set data of patients or clinical images were collected, and no provenance information is provided.
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 performed, no ground truth needed to be established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical 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. No clinical studies were carried out, and the device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool as described in the context of improving 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 a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established for a test set. The ground truth for proving substantial equivalence was based on regulatory compliance and comparison to existing cleared devices.
8. The sample size for the training set
Not applicable. No machine learning algorithm or training set is mentioned in the context of this 510(k) submission for demonstrating substantial equivalence. The "training" of the device refers to its engineering and verification processes in compliance with standards, not a machine learning training set.
9. How the ground truth for the training set was established
Not applicable. No machine learning algorithm or training set with associated ground truth is referenced.
§ 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.