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510(k) Data Aggregation
(27 days)
LOGIQ 500
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(30 days)
GE LOGIQ 500
The LOGIQ 500 with Harmonic Imaging is a general purpose utrasound 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, pediatric, small organ, cephalic, cardiac, transesophageal, transvaginal, peripheral vascular, intra-operative, neurological, and musculo-skeletal.
The LOGIQ 500 with Harmonic Imaging is a mobile console approximately 53 cm wide, 94 cm deep and 130 cm high equipped with a keyboard control panel, small A/N display panel, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.
Here’s an analysis of the acceptance criteria and study information based on the provided text, using the specified format.
GE LOGIQ 500 with Harmonic Imaging Modification
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: | The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. A postclearance special report containing complete information, including acoustic output measurements based on production line devices, is required to be submitted to the FDA. |
| Effectiveness: | Harmonic imaging is implemented with conventional digital image processing technology. Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The device is considered substantially equivalent to the currently marketed GE LOGIQ 500 (predicate device) in terms of technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, operating modes, and transducers. The indications for use for the LOGIQ 500 with Harmonic Imaging are consistent with those previously cleared for the LOGIQ 500, with specific additions for certain transducers (S222, S317, and C358) across various clinical applications and modes of operation (e.g., Abdominal, Adult Cephalic, Cardiac, Other for S222; Abdominal, Cardiac for S317). |
| Quality System: | The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards. |
| **Substantial ** | The GE LOGIQ 500 with Harmonic Imaging is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 500. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, operating modes and transducers as the predicate device. Diagnostic ultrasound has accumulated a long history of safe and effective performance. The FDA reviewed the 510(k) and determined the device is substantially equivalent for the indications for use stated to legally marketed predicate devices. Key transducers (C358, S317, S222) were also determined to be substantially equivalent for their described uses. |
| Equivalence: |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission states "Clinical Tests: None required." The assessment for this device was based on non-clinical tests (acoustic output, biocompatibility, thermal, electrical, and mechanical safety) and a comparison to a predicate device.
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was used.
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 MRMC comparative effectiveness study was done. This device is an ultrasound system with a "Harmonic Imaging" modification, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an ultrasound imaging system, not an algorithm, and its performance inherently involves a human operator for image acquisition and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission. The primary ground for acceptance was substantial equivalence to a predicate device and compliance with safety standards.
8. The sample size for the training set:
- Not applicable, as this is an ultrasound system and not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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(286 days)
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
LOGIQ 500 is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical
The LOGIQ 500 diagnostic ultrasound system with the described modifications is intended for general radiological and cardiac use and consists of a mobile console and assorted transducers. 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.
The provided 510(k) summary for the GE LOGIQ 500 Diagnostic Ultrasound System is a submission intended to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria.
Therefore, the document does not contain explicit acceptance criteria or a study designed to prove the device meets such criteria. Instead, it relies on the concept of substantial equivalence to already cleared devices.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission.
This document describes a device seeking clearance based on substantial equivalence, not a device establishing new performance claims that require specific acceptance criteria and a detailed performance study against those criteria. The "performance" reported primarily relates to compliance with safety standards and functional equivalence to predicate devices, rather than quantitative clinical performance metrics.
The "Summary of Studies" section vaguely states: "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." This implies the acceptance criteria are adherence to these established safety standards, but no specific numerical performance metrics are provided.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable.
There is no mention of a "test set" in the context of clinical performance evaluation. The submission focuses on technical specifications, safety compliance, and comparison to predicate devices, not on a clinical test set for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
As there is no described test set for clinical performance evaluation, there is no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable.
Without a test set and ground truth establishment, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable.
This submission is for a diagnostic ultrasound system, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
This submission is for a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
Not applicable (in the sense of clinical performance ground truth).
The "ground truth" implied in this submission relates to:
- Compliance with safety standards: The "truth" is whether the device meets the specified technical requirements of applicable medical device safety standards.
- Substantial equivalence: The "truth" is whether the device is comparable in safety and effectiveness to the identified predicate devices (ATL HDI 3000 and GE Medical Systems LOGIQ 500).
8. The Sample Size for the Training Set
Not applicable.
This submission describes a diagnostic ultrasound system, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no training set mentioned, no ground truth establishment for it is described.
In summary, the provided document for the GE LOGIQ 500 Diagnostic Ultrasound System is a 510(k) summary relying on substantial equivalence, and therefore does not include detailed clinical performance studies with acceptance criteria, test sets, or ground truth as would be seen for novel devices making specific diagnostic claims, especially those involving AI/ML components. The primary "study" mentioned is the evaluation against existing safety standards, and the "acceptance criterion" is conformance to those standards, alongside demonstrating equivalence to predicate devices.
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