(30 days)
The GE LOGIQ 700 with CE is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid: neonatal cephalic: cardiac adult and pediatric: TR: TV: PV; urological; and conventional and superficial musculo-skeletal.
The GE LOGIQ 700 with CE is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. Coded Excitation is useful for enhancing B or M mode performance characteristics providing improved high frequency depth penetration without loss of spatial resolution.
The GE LOGIQ 700 Diagnostic Ultrasound with coded excitation (CE) modification is an ultrasonic pulsed echo imaging system. The submission documents indicate that this device is substantially equivalent to the currently marketed GE LOGIQ 700. The primary claim here is on substantial equivalence to an existing device, rather than new performance criteria being proven.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for substantial equivalence with a modification (coded excitation) to an already cleared device, the "acceptance criteria" are not framed as specific performance metrics to be met by a new algorithm or diagnostic capability. Instead, the acceptance criteria are met by demonstrating that the modified device has comparable technological characteristics, safety, and effectiveness to the predicate device.
The reported device performance, in this context, is that the Coded Excitation is useful for enhancing B or M mode performance characteristics, providing improved high frequency depth penetration without loss of spatial resolution, and it utilizes conventional digital image processing technology.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Comparable technological characteristics to predicate device | Utilizes conventional digital image processing technology for Coded Excitation. |
| Comparable in key safety features to predicate device | Evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety. Found to conform with applicable medical device safety standards. |
| Comparable in effectiveness features to predicate device | Coded Excitation is useful for enhancing B or M mode performance characteristics, providing improved high frequency depth penetration without loss of spatial resolution. |
| Same intended uses, operating modes, and probes as predicate device | Yes, the device has the same intended uses, operating modes, and probes as the predicate (GE LOGIQ 700). Specific transducers (548c, M7c, 618e, 618c, 739L) are cleared for various clinical applications. |
| Conformance to applicable medical device safety standards and quality systems | Conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. Compliance verified through independent evaluation with factory surveillance. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set was required for this submission.
- Data Provenance: Not applicable. No clinical studies were conducted to prove clinical efficacy. The assessment was based on non-clinical tests and a comparison of technological characteristics to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical test set with medical expert ground truth was required or performed.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was utilized.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of the query.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The Coded Excitation is a hardware/software modification to enhance image quality in the ultrasound system, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission primarily relies on non-clinical testing results demonstrating compliance with safety standards (acoustic output, biocompatibility, thermal, electrical, mechanical safety) and the established safe and effective performance history of diagnostic ultrasound technology in general and the predicate GE LOGIQ 700 system. The "ground truth" for the effectiveness of the Coded Excitation is described as enhancing B or M mode performance, providing improved high frequency depth penetration without loss of spatial resolution, which is a technical characteristic rather than a clinical diagnostic outcome.
8. The Sample Size for the Training Set
- Not applicable. The "Coded Excitation" technology is described as implemented with conventional digital image processing, and there is no mention of a machine learning model requiring a training set in the context of this 1999 submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no training set for a machine learning model was used.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The study proving the device meets its acceptance criteria is primarily a non-clinical assessment and a comparison to a predicate device, rather than a clinical trial.
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Non-clinical Tests: The device underwent evaluation for:
- Acoustic output
- Biocompatibility
- Thermal safety
- Electrical safety
- Mechanical safety
The device was found to conform with applicable medical device safety standards in these non-clinical tests.
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Technological Comparison and Feature Description: The submission argues for substantial equivalence by stating that the modified GE LOGIQ 700 with CE has:
- The same technological characteristics (with CE being a digital image processing enhancement).
- Comparable key safety and effectiveness features to the predicate GE LOGIQ 700.
- The same basic design, construction, and materials.
- The same intended uses, operating modes, and probes.
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Rationale for No Clinical Tests: "Clinical Tests: None required." This statement is based on the argument of substantial equivalence to an already cleared device, leveraging the long history of safe and effective performance of diagnostic ultrasound, and the fact that the coded excitation is an enhancement to an existing technology rather than a fundamentally new diagnostic modality. The claim is that the modification via Coded Excitation (providing improved high frequency depth penetration without loss of spatial resolution) is an inherent performance characteristic of the system rather than a new diagnostic capability that would require clinical validation.
In essence, the "study" for this 510(k) submission is the comprehensive documentation and testing showing that the modified device remains safe, performs as intended, and does not raise new questions of safety or effectiveness when compared to its existing, legally marketed predicate device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.