(17 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); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The GE LOGIQ 7 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 60 cm wide, 100 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD touch panel. This modification will provide users with improved ergonomics, image enhancement and productivity.
The provided document is a 510(k) premarket notification for the GE LOGIQ 7 Diagnostic Ultrasound System, BT04 modification. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets such criteria in the way you've outlined. Instead, it asserts equivalence to a previously cleared device.
Specifically:
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A table of acceptance criteria and the reported device performance: Not present. The document focuses on listing the intended uses (clinical applications and modes of operation) for the system and its various transducers, noting whether these were "previously cleared" (P) or "new" (N). It does not provide quantitative performance metrics against acceptance criteria.
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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): Not applicable, as no clinical study for performance evaluation is described. The document states: "2. Clinical Tests: None required."
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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): Not applicable, as no clinical study for performance evaluation is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study for performance evaluation is described.
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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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No AI component is mentioned, and no MRMC study is described.
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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 algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study for performance evaluation is described.
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The sample size for the training set: Not applicable, as no AI/machine learning component requiring a training set is mentioned.
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How the ground truth for the training set was established: Not applicable, as no AI/machine learning component requiring a training set is mentioned.
Summary of Device Equivalence (from the document):
The document states that the GE LOGIQ 7 BT04 (modified device) is "substantially equivalent to the current GE LOGIQ 7" (predicate device). It asserts that the modified device has:
- The same technological characteristics.
- Key safety and effectiveness features.
- Physical design, construction.
- The same intended uses and basic operating modes as the predicate device.
The basis for this assertion is non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, and mechanical safety, conforming to applicable medical device safety standards) and the statement that "Diagnostic ultrasound has accumulated a long history of safe and effective performance." No new clinical data or performance studies are presented because they were "None required" for this modification and 510(k) submission type.
§ 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.