(27 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, vascular and neurological).
The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system available in Expert (full featured) or Pro (reduced feature) versions consists of a mobile console approximately 52 cm wide. 99 cm deep and 135 cm high that provides digital image acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification adds coded pulse modes from high-end LOGIQ systems to the Expert version and removes provides limited options for the Pro version.
The provided document is a 510(k) premarket notification for the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound System, which was filed in 2003. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study as would be required for novel devices or those with significant changes in indications for use.
Therefore, the document does not contain information related to acceptance criteria or clinical studies designed to prove device performance in the way a modern AI/ML device submission would. Instead, it focuses on demonstrating that the new ultrasound system is as safe and effective as its predicate device.
Here's why the requested information is absent and what the document does provide:
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A table of acceptance criteria and the reported device performance: This is not present. The submission is not structured around demonstrating performance against predefined metrics in a clinical trial. The "performance" assessment is based on comparison to the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a clinical study for performance evaluation is mentioned because no such clinical study was required for this 510(k) submission.
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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): No ground truth establishment or expert involvement for performance validation is described, as it was not required for this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no clinical test set for performance validation.
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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 is an ultrasound imaging system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for performance evaluation was established.
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The sample size for the training set: Not applicable, as this is not an AI/ML device relying on a training set.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
What the document does describe as proof of safety and effectiveness:
The submission relies on demonstrating substantial equivalence to an already legally marketed device (the GE LOGIQ 5 diagnostic ultrasound system, K014097). This is a common pathway for medical devices that are similar to existing ones.
The "proof" in this context is outlined in Section b):
- Non-clinical Tests: The device was evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, and mechanical safety
- It was found to conform with applicable medical device safety standards.
- Clinical Tests: "None required." This explicitly states that no clinical trials were deemed necessary by the FDA for this particular 510(k) submission, precisely because it was being cleared based on substantial equivalence.
- Conclusion: GE Medical Systems asserts that the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound is substantially equivalent to devices currently cleared for market based on:
- Consistent intended uses and other key features with traditional clinical practice, FDA guidelines, and established methods of patient examination.
- Conformity of the design and development process with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
- Compliance with applicable medical device safety standards, verified through independent evaluation and ongoing factory surveillance.
- The long history of safe and effective performance of diagnostic ultrasound in general.
In summary, this document reflects a regulatory submission from 2003 for an ultrasound system, not an AI/ML device. Therefore, the detailed performance criteria and study design elements typically associated with AI/ML device validation are not present. Instead, "proof" of acceptance is based on compliance with manufacturing standards, non-clinical safety testing, and substantial equivalence to a predicate device already on the market.
§ 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.