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510(k) Data Aggregation
(23 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The GE Marlin is a full featured echocardiography system in a highly compact and portable package. It has a full complement of interchangeable electronic array transducers giving it additional capability in general imaging. Although this modificantly changes the size and packaging of the device, it does retain the same intended use and overall imaging capability as the unmodified GE Vivid 3
The GE Marlin Diagnostic Ultrasound System, cleared under K033139, is primarily a re-packaging of an existing device (GE Vivid 3) into a more compact and portable form, while also adding interchangeability with several new transducers. As such, the submission primarily focuses on establishing substantial equivalence based on technical characteristics, safety, and functionality rather than clinical performance metrics in a way that would require specific acceptance criteria and a study to prove they are met.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific quantitative acceptance criteria or reported device performance metrics in the way one might expect for an AI/CADe device (e.g., sensitivity, specificity, AUC). Instead, it establishes substantial equivalence by demonstrating that the GE Marlin system (including its various transducers) performs functions and uses technology comparable to existing cleared devices.
The "performance" is implicitly defined by its "Intended Use" and "Mode of Operation" for various clinical applications, which are identical to or a subset of those already cleared for the predicate devices. The acceptance criteria essentially revolve around meeting established safety standards and maintaining equivalent imaging capabilities to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit/Demonstrated) |
|---|---|
| Intended Use: Device offers ultrasound evaluation for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organ, etc.) | The GE Marlin Diagnostic Ultrasound System, with its various transducers (3C-RS, 8C-RS, E8C-RS, 8L-RS, i12L-RS, i/t739-RS, 3S-RS, 7S-RS, 10S-RS, 6T-RS, 9T-RS, P2D, P6D), is indicated for all listed diagnostic ultrasound imaging and fluid flow analysis applications (refer to "Indications for Use Forms" for each transducer). These indications are either "P" (previously cleared by FDA) or "N" (new indication, implying similar functionality to an existing predicate). |
| Mode of Operation: Supports standard ultrasound modes (B, M, PW Doppler, CW Doppler, Color Doppler, etc.) for each application. | All listed transducers support various combinations of B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, and Harmonic Imaging, as indicated by "P" or "N" on the respective tables. |
| Safety: Conforms to applicable medical device safety standards (acoustic output, biocompatibility, thermal, electrical, mechanical). | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." Additionally, "ongoing production surveillance" verifies compliance. |
| Substantial Equivalence to Predicate Device (GE Vivid 3): Same intended use and overall imaging capability. | "The GE Marlin is a comparable type and substantially equivalent to the unmodified Vivid 3 in terms of intended use and clinical utility." It shares "the same technological characteristics, overall design, construction methods and materials." |
| Substantial Equivalence to GE LOGIQ Book: Comparable physical size and portability. | "Additionally, it is comparable to the GE LOGIQ Book with respect to physical size and portability." |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "2. Clinical Tests: None required."
Therefore, there was no separate "test set" in the context of clinical performance evaluation (e.g., for accuracy, sensitivity, specificity). The substantial equivalence justification relies on non-clinical tests and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical tests or test sets were explicitly detailed for new performance claims, there were no experts establishing ground truth in this context. The "ground truth" for the device itself is its design and manufacturing adherence to safety standards and its functional equivalence to already cleared devices.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was described.
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. This submission is for a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device, and no MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device requiring standalone performance evaluation. It is an imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims in this submission is the established safety and effectiveness of the predicate GE Vivid 3 and GE LOGIQ Book ultrasound systems, and the manufacturer's verification through non-clinical testing (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety) that the GE Marlin system meets these standards and maintains equivalent functionality. There is no external clinical ground truth established for the Marlin system itself that is presented.
8. The Sample Size for the Training Set
Not applicable, as this is hardware (an ultrasound system), not a software algorithm that requires 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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